Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS (CURRENT/OASIS7)

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ClinicalTrials.gov Identifier: NCT00335452

Recruitment Status : Completed

First Posted : June 9, 2006

Results First Posted : October 7, 2010

Last Update Posted : November 18, 2010

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by:

Sanofi

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Acute Coronary Disease Angina Unstable
Interventions	Drug: Clopidogrel Drug: acetylsalicyclic acid (ASA)
Enrollment	25086

Participant Flow

Recruitment Details	25086 patients were enrolled and randomized between June 2006 and August 2009 in 597 sites in 39 countries. Because the observed overall blinded event rate was substantially lower than expected, the number of patients to be enrolled was increased from 18000 to 20000, then to 25000.
Pre-assignment Details	Treatment assignment was performed through an automated voice randomization service (AreS). At the same time, the AReS provided allocation to a Clopidogrel treatment regimen according to a pre-defined randomization list and to a ASA dose according to a factorial design.


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
Arm/Group Description	Day 1: Clopidogrel 300 mg loading d...	Day 1: Clopidogrel 300 mg loading d...	Day 1: Clopidogrel 600 mg loading d...	Day 1: Clopidogrel 600 mg loading d...
Arm/Group Description	Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg	Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg	Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg	Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
Period Title: Overall Study
Started	6312 ^[1]	6254 ^[1]	6267 ^[1]	6253 ^[1]
TREATED WITH CLOPIDOGREL	6271	6218	6228	6217
TREATED WITH ASA	6302	6251	6261	6247
Completed	6154 ^[2]	6107 ^[2]	6108 ^[2]	6122 ^[2]
Not Completed	158	147	159	131
Reason Not Completed
Death	156	144	158	129
Lost to Follow-up	2	3	1	2
[1] Randomized [2] Completed 30 days follow-up period

Baseline Characteristics

Arm/Group Title		Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose	Total
Arm/Group Description		[Not Specified]	[Not Specified]	[Not Specified]	[Not Specified]	Total of all reporting groups
Arm/Group Description		[Not Specified]	[Not Specified]	[Not Specified]	[Not Specified]	Total of all reporting groups
Overall Number of Baseline Participants		6312	6254	6267	6253	25086
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
		61.3 (11.7)	61.5 (11.7)	61.2 (11.8)	61.4 (11.9)	61.3 (11.8)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
< 65 years		3792	3740	3787	3735	15054
65 - 74 years		1573	1576	1543	1543	6235
≥ 75 years		947	937	937	975	3796
Missing		0	1	0	0	1
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
	Female	1702 27.0%	1756 28.1%	1671 26.7%	1742 27.9%	6871 27.4%
	Male	4610 73.0%	4498 71.9%	4596 73.3%	4511 72.1%	18215 72.6%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
Argentina		182	159	162	174	677
Australia		97	100	96	95	388
Austria		41	35	35	40	151
Belgium		55	61	59	53	228
Brazil		292	275	270	288	1125
Bulgaria		111	122	125	112	470
Canada		349	379	373	347	1448
Chile		95	85	82	90	352
China		510	492	500	515	2017
Croatia		114	145	144	114	517
Czech Republic		257	275	277	258	1067
Estonia		1	0	0	1	2
Finland		132	127	127	132	518
France		177	163	165	175	680
Germany		471	450	453	470	1844
Greece		20	21	23	21	85
India		658	650	645	646	2599
Ireland		24	13	15	23	75
Israel		286	272	275	282	1115
Italy		232	260	258	231	981
Korea, Republic of		161	149	152	165	627
Latvia		16	16	15	15	62
Lithuania		26	31	30	28	115
Malaysia		29	39	39	28	135
Mexico		16	17	19	17	69
Netherlands		46	48	48	46	188
New Zealand		36	31	29	29	125
Poland		365	322	325	362	1374
Romania		47	30	33	48	158
Russian Federation		132	137	138	131	538
Singapore		10	13	15	10	48
Slovakia		93	84	83	92	352
South Africa		24	14	14	23	75
Spain		264	276	283	263	1086
Sweden		10	11	9	10	40
Switzerland		51	64	64	48	227
Turkey		79	96	94	78	347
United Kingdom		28	29	34	28	119
United States		775	763	759	765	3062
Qualifying condition Measure Type: Number Unit of measure: Participants	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
Suspected Unstable Angina (UA)		1809	1771	1757	1877	7214
Suspected MI without ST elevation (NSTEMI)		2662	2662	2668	2539	10531
MI with ST elevation (STEMI)		1839	1817	1839	1832	7327
Missing		2	4	3	5	14
Intended PCI performed ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	6312 participants	6254 participants	6267 participants	6253 participants	25086 participants
Yes		4377	4326	4262	4298	17263
No		1935	1928	2005	1955	7823
		[1] Measure Description: The intent to perform a PCI as early as possible and no later than 72 hours of randomization was part of the criteria for inclusion

Outcome Measures

1.Primary Outcome


Title	First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
Description	The primary endpoint is the first occurrence of any of the following e...
Description	The primary endpoint is the first occurrence of any of the following events: Cardiovascular death (any death with a clear cardiovascular or unknown cause), Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA	Clopidogrel 600/150/75 mg + ASA
Arm/Group Description:	Patients randomized to the Clopidog...	Patients randomized to the Clopidog...
Arm/Group Description:	Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose	Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
Overall Number of Participants Analyzed	12566	12520
Measure Type: Number Unit of Measure: participants
CV death/MI/Stroke	557	522
- CV death	222	226
- MI (fatal or not)	274	237
- Stroke (fatal or not)	61	59

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA, Clopidogrel 600/150/75 mg + ASA
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3037
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	6.1
	Confidence Interval	(2-Sided) 95% -5.8 to 16.6
	Estimation Comments	The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.

2.Primary Outcome


Title	First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
Description	[Not Specified]
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.


Arm/Group Title	Clopidogrel + ASA Low Dose	Clopidogrel + ASA High Dose
Arm/Group Description:	Patients treated with ASA low dose ...	Patients treated with ASA high dose...
Arm/Group Description:	Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen	Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
Overall Number of Participants Analyzed	12563	12498
Measure Type: Number Unit of Measure: participants
CV death/MI/Stroke	546	527
- CV death	231	211
- MI (fatal or not)	260	251
- Stroke (fatal or not)	55	65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel + ASA Low Dose, Clopidogrel + ASA High Dose
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6047
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95% -9.2 to 14.0
	Estimation Comments	The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.

3.Primary Outcome


Title	First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
Description	[Not Specified]
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
Arm/Group Description:	[Not Specified]	[Not Specified]	[Not Specified]	[Not Specified]
Arm/Group Description:	[Not Specified]	[Not Specified]	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	6312	6254	6267	6253
Measure Type: Number Unit of Measure: participants
	267	290	282	240

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA Low Dose, Clopidogrel 600/150/75 mg + ASA Low Dose
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4579
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95% -26.0 to 9.9
	Estimation Comments	The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA High Dose, Clopidogrel 600/150/75 mg + ASA High Dose
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0262
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	17.6
	Confidence Interval	(2-Sided) 95% 2.2 to 30.5
	Estimation Comments	The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA Low Dose, Clopidogrel 300/75/75 mg + ASA High Dose, Clopidogrel 600/150/75 mg + ASA Low Dose, Clopidogrel 600/150/75 mg + ASA High Dose
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0355
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Chi-squared
	Comments	Interaction chi-squared test of the Cox proportional hazards model.

4.Primary Outcome


Title	First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
Description	[Not Specified]
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA	Clopidogrel 600/150/75 mg + ASA
Arm/Group Description:	Patients randomized to the Clopidog...	Patients randomized to the Clopidog...
Arm/Group Description:	Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose	Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
Overall Number of Participants Analyzed	8703	8560
Measure Type: Number Unit of Measure: participants
CV death/MI/Stroke	392	330
- CV death	132	130
- MI (fatal or not)	225	172
- Stroke (fatal or not)	35	28

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA, Clopidogrel 600/150/75 mg + ASA
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0332
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95% 1.2 to 26.3
	Estimation Comments	The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.

5.Secondary Outcome


Title	Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
Description	Major bleeding is defined as any severe bleeding (associated with any ...
Description	Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA	Clopidogrel 600/150/75 mg + ASA
Arm/Group Description:	Patients randomized to the Clopidog...	Patients randomized to the Clopidog...
Arm/Group Description:	Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose	Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
Overall Number of Participants Analyzed	12566	12520
Measure Type: Number Unit of Measure: participants
Major bleeding	255	313
- Severe bleeding	195	236
- Major but not severe bleeding	65	83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA, Clopidogrel 600/150/75 mg + ASA
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.012
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Regression, Logistic
	Comments	logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).

6.Secondary Outcome


Title	Occurrence of Major Bleeding - ASA Dose Level Comparison
Description	[Not Specified]
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.


Arm/Group Title	Clopidogrel + ASA Low Dose	Clopidogrel + ASA High Dose
Arm/Group Description:	Patients treated with ASA low dose ...	Patients treated with ASA high dose...
Arm/Group Description:	Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen	Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
Overall Number of Participants Analyzed	12563	12498
Measure Type: Number Unit of Measure: participants
Major bleeding	285	282
- Severe bleeding	215	216
- Major but not severe bleeding	74	73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel + ASA Low Dose, Clopidogrel + ASA High Dose
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.945
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Regression, Logistic
	Comments	Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).

7.Post-Hoc Outcome


Title	Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison
Description	This includes definite stent thrombosis (confirmed by angiography or e...
Description	This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Clopidogrel 300/75/75 mg + ASA	Clopidogrel 600/150/75 mg + ASA
Arm/Group Description:	Patients randomized to the Clopidog...	Patients randomized to the Clopidog...
Arm/Group Description:	Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose	Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
Overall Number of Participants Analyzed	12566	12520
Measure Type: Number Unit of Measure: participants
Stent trombosis	200	135
- Definite	111	58
- Probable	89	77

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel 300/75/75 mg + ASA, Clopidogrel 600/150/75 mg + ASA
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	The a priori threshold for statistical significance is ≤0.05.
	Method	Log Rank
	Comments	Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.

Method of Estimation	Estimation Parameter	Relative Risk Reduction (%)
	Estimated Value	32.6
	Confidence Interval	(2-Sided) 95% 16.2 to 45.8
	Estimation Comments	The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	The analysis is on the intent-to-treat population (ITT). All patients were included in the treatment arm to which they were allocated by the AReS. Any adverse event that developed or worsened on or after randomization up to the day of the final follow-up visit was included.

Arm/Group Title	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
Arm/Group Description	Day 1: Clopidogrel 300 mg loading d...	Day 1: Clopidogrel 300 mg loading d...	Day 1: Clopidogrel 600 mg loading d...	Day 1: Clopidogrel 600 mg loading d...
Arm/Group Description	Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg	Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg	Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg	Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg
All-Cause Mortality
	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	322/6312 (5.10%)	329/6254 (5.26%)	372/6267 (5.94%)	332/6253 (5.31%)
Blood and lymphatic system disorders
Haemorrhagic anaemia ^* 1	7/6312 (0.11%)	5/6254 (0.08%)	4/6267 (0.06%)	6/6253 (0.10%)
Anaemia ^* 1	5/6312 (0.08%)	1/6254 (0.02%)	3/6267 (0.05%)	5/6253 (0.08%)
Thrombocytopenia ^* 1	2/6312 (0.03%)	3/6254 (0.05%)	4/6267 (0.06%)	2/6253 (0.03%)
Nephrogenic anaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Heparin-induced thrombocytopenia ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	1/6253 (0.02%)
Anaemia of chronic disease ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Eosinophilia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Normochromic normocytic anaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Disseminated intravascular coagulation ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Iron deficiency anaemia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
White blood cell disorder ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Lymphadenopathy ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Microcytic anaemia ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Splenic infarction ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Cardiac disorders
Pericardial haemorrhage ^* 1	15/6312 (0.24%)	12/6254 (0.19%)	18/6267 (0.29%)	11/6253 (0.18%)
Intracardiac thrombus ^* 1	1/6312 (0.02%)	2/6254 (0.03%)	1/6267 (0.02%)	5/6253 (0.08%)
Pericarditis ^* 1	3/6312 (0.05%)	1/6254 (0.02%)	2/6267 (0.03%)	1/6253 (0.02%)
Acute left ventricular failure ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Atrial thrombosis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Cardiac perforation ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Cardiogenic shock ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Interventricular septum rupture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Myopericarditis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Mitral valve incompetence ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Cardiac tamponade ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Bradyarrhythmia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Cardiac arrest ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Cardiac failure congestive ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Haemorrhage coronary artery ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Myocarditis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Right ventricular dysfunction ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Cardiac failure ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	0/6253 (0.00%)
Cardiopulmonary failure ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Coronary artery thrombosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Myocardial infarction ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Pericardial effusion ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Cardio-respiratory arrest ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Dressler's syndrome ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Left ventricular failure ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Palpitations ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Congenital, familial and genetic disorders
Ventricular septal defect ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Gastrointestinal angiodysplasia haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Atrial septal defect ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Phimosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Ear and labyrinth disorders
Vertigo ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Deafness ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Hypoacusis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Endocrine disorders
Pituitary cyst ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Eye disorders
Diplopia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Retinal detachment ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Glaucoma ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Gastrointestinal disorders
Gastrointestinal haemorrhage ^* 1	13/6312 (0.21%)	12/6254 (0.19%)	15/6267 (0.24%)	15/6253 (0.24%)
Retroperitoneal haemorrhage ^* 1	2/6312 (0.03%)	4/6254 (0.06%)	9/6267 (0.14%)	8/6253 (0.13%)
Upper gastrointestinal haemorrhage ^* 1	3/6312 (0.05%)	6/6254 (0.10%)	3/6267 (0.05%)	6/6253 (0.10%)
Gastritis ^* 1	2/6312 (0.03%)	3/6254 (0.05%)	2/6267 (0.03%)	3/6253 (0.05%)
Gastrointestinal ulcer haemorrhage ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	2/6267 (0.03%)	3/6253 (0.05%)
Abdominal pain upper ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	3/6253 (0.05%)
Gastric haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	3/6253 (0.05%)
Retroperitoneal haematoma ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	2/6267 (0.03%)	2/6253 (0.03%)
Duodenal ulcer haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	2/6253 (0.03%)
Peptic ulcer ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Constipation ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Pancreatitis acute ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Colitis ischaemic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Duodenal ulcer ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Diarrhoea ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Gastritis haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Oesophagitis haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Abdominal discomfort ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Gastritis erosive ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Haematemesis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Intestinal ischaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Tongue haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Pancreatitis ^* 1	0/6312 (0.00%)	4/6254 (0.06%)	2/6267 (0.03%)	0/6253 (0.00%)
Gastrooesophageal reflux disease ^* 1	0/6312 (0.00%)	3/6254 (0.05%)	2/6267 (0.03%)	0/6253 (0.00%)
Haemorrhoidal haemorrhage ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	1/6267 (0.02%)	0/6253 (0.00%)
Gastric ulcer haemorrhage ^* 1	2/6312 (0.03%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Abdominal pain ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Colonic pseudo-obstruction ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gastric ulcer ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gastrointestinal pain ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Ileus ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Lumbar hernia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Nausea ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Rectal haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Small intestinal obstruction ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Vomiting ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Dysphagia ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Diverticulum intestinal haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Enterocolitis haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Gastrointestinal ischaemia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Haemorrhagic erosive gastritis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Intestinal obstruction ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Peptic ulcer haemorrhage ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Periodontitis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Peritonitis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Acute abdomen ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Diverticular perforation ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Gastric polyps ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Hiatus hernia ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Large intestinal haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Melaena ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Mesenteric vein thrombosis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Reflux oesophagitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
General disorders
Puncture site haemorrhage ^* 1	17/6312 (0.27%)	21/6254 (0.34%)	22/6267 (0.35%)	31/6253 (0.50%)
Pyrexia ^* 1	1/6312 (0.02%)	5/6254 (0.08%)	0/6267 (0.00%)	4/6253 (0.06%)
Vessel puncture site haematoma ^* 1	2/6312 (0.03%)	2/6254 (0.03%)	1/6267 (0.02%)	2/6253 (0.03%)
Chest pain ^* 1	2/6312 (0.03%)	3/6254 (0.05%)	5/6267 (0.08%)	1/6253 (0.02%)
Multi-organ failure ^* 1	1/6312 (0.02%)	2/6254 (0.03%)	3/6267 (0.05%)	1/6253 (0.02%)
Non-cardiac chest pain ^* 1	4/6312 (0.06%)	2/6254 (0.03%)	2/6267 (0.03%)	1/6253 (0.02%)
Catheter site haematoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Implant site haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Inflammation ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Necrosis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Systemic inflammatory response syndrome ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Oedema peripheral ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Application site erosion ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Catheter site haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gait disturbance ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Mechanical complication of implant ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Implant site haematoma ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Fatigue ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Hepatobiliary disorders
Cholecystitis acute ^* 1	3/6312 (0.05%)	4/6254 (0.06%)	1/6267 (0.02%)	2/6253 (0.03%)
Cholelithiasis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Bile duct obstruction ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Hepatitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Cholecystitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Cholangitis ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Hepatic failure ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Acute hepatic failure ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Biliary colic ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Hyperbilirubinaemia ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Immune system disorders
Hypersensitivity ^* 1	3/6312 (0.05%)	0/6254 (0.00%)	1/6267 (0.02%)	3/6253 (0.05%)
Anaphylactic shock ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Anaphylactic reaction ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Drug hypersensitivity ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Infections and infestations
Pneumonia ^* 1	21/6312 (0.33%)	11/6254 (0.18%)	22/6267 (0.35%)	16/6253 (0.26%)
Septic shock ^* 1	4/6312 (0.06%)	2/6254 (0.03%)	5/6267 (0.08%)	4/6253 (0.06%)
Urinary tract infection ^* 1	3/6312 (0.05%)	0/6254 (0.00%)	3/6267 (0.05%)	3/6253 (0.05%)
Postoperative wound infection ^* 1	3/6312 (0.05%)	3/6254 (0.05%)	2/6267 (0.03%)	3/6253 (0.05%)
Bronchopneumonia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	2/6253 (0.03%)
Bronchitis ^* 1	2/6312 (0.03%)	2/6254 (0.03%)	1/6267 (0.02%)	2/6253 (0.03%)
Gastroenteritis ^* 1	4/6312 (0.06%)	1/6254 (0.02%)	1/6267 (0.02%)	2/6253 (0.03%)
Lobar pneumonia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	2/6253 (0.03%)
Diverticulitis ^* 1	1/6312 (0.02%)	2/6254 (0.03%)	0/6267 (0.00%)	2/6253 (0.03%)
Cellulitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	2/6267 (0.03%)	1/6253 (0.02%)
Lower respiratory tract infection ^* 1	3/6312 (0.05%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Lung infection ^* 1	2/6312 (0.03%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Pseudomembranous colitis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Post procedural infection ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Post procedural sepsis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Viral infection ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Bronchiolitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Catheter related infection ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Graft infection ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Infected skin ulcer ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Necrotising fasciitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Sepsis ^* 1	4/6312 (0.06%)	3/6254 (0.05%)	5/6267 (0.08%)	0/6253 (0.00%)
Wound infection ^* 1	1/6312 (0.02%)	4/6254 (0.06%)	3/6267 (0.05%)	0/6253 (0.00%)
Appendicitis ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	1/6267 (0.02%)	0/6253 (0.00%)
Bacteraemia ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Endocarditis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Application site infection ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gallbladder empyema ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gastrointestinal infection ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Haematoma infection ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Influenza ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Pulmonary sepsis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Sinusitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Mediastinitis ^* 1	0/6312 (0.00%)	3/6254 (0.05%)	0/6267 (0.00%)	0/6253 (0.00%)
Dengue fever ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	0/6253 (0.00%)
Osteomyelitis ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Pyelonephritis ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Upper respiratory tract infection ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Catheter sepsis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Erysipelas ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Gangrene ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Meningitis coxsackie viral ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Pneumonia primary atypical ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Post procedural pneumonia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Pyelonephritis acute ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Respiratory tract infection ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Endocarditis bacterial ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Escherichia sepsis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Incision site infection ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Liver abscess ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Lower respiratory tract infection viral ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Myocarditis infectious ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Peridiverticulitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Peritoneal infection ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Puncture site infection ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Staphylococcal mediastinitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Urosepsis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Injury, poisoning and procedural complications
Operative haemorrhage ^* 1	39/6312 (0.62%)	50/6254 (0.80%)	57/6267 (0.91%)	48/6253 (0.77%)
Vascular pseudoaneurysm ^* 1	7/6312 (0.11%)	8/6254 (0.13%)	7/6267 (0.11%)	9/6253 (0.14%)
Post procedural haemorrhage ^* 1	12/6312 (0.19%)	16/6254 (0.26%)	18/6267 (0.29%)	6/6253 (0.10%)
Wound dehiscence ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Fall ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Compression fracture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Confusion postoperative ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Deep vein thrombosis postoperative ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Fat embolism ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Lower limb fracture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Overdose ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Subcutaneous haematoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Incision site haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Collapse of lung ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Femur fracture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Haematuria traumatic ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Haemolytic transfusion reaction ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Hepatic haematoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Post procedural haematoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Postoperative fever ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Rib fracture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Tibia fracture ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Vascular pseudoaneurysm ruptured ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Agitation postoperative ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	0/6253 (0.00%)
Postpericardiotomy syndrome ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	0/6253 (0.00%)
Subdural haematoma ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Traumatic haemorrhage ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Anaesthetic complication pulmonary ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Cardiac procedure complication ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Complication of device removal ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Facial bones fracture ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Incisional hernia, obstructive ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Joint dislocation ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Wound ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Anaemia postoperative ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Chest injury ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Hip fracture ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Mechanical ventilation complication ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Procedural hypotension ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Subdural haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Investigations
Haemoglobin decreased ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	5/6267 (0.08%)	2/6253 (0.03%)
Blood creatinine increased ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Platelet count decreased ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Hepatic enzyme increased ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Metabolism and nutrition disorders
Dehydration ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	3/6253 (0.05%)
Gout ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Hypoglycaemia ^* 1	4/6312 (0.06%)	2/6254 (0.03%)	0/6267 (0.00%)	1/6253 (0.02%)
Hyperkalaemia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Diabetes mellitus ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Hydraemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Hyponatraemia ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Hyperglycaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Diabetes mellitus inadequate control ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Fluid retention ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Hypocalcaemia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Fluid overload ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Musculoskeletal and connective tissue disorders
Compartment syndrome ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Musculoskeletal chest pain ^* 1	2/6312 (0.03%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Myalgia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Osteoarthritis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Gouty tophus ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Musculoskeletal pain ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Gouty arthritis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Intervertebral disc protrusion ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Muscle haemorrhage ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Muscular weakness ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Osteochondrosis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Lung neoplasm malignant ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Benign hepatic neoplasm ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Pituitary tumour benign ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Bronchial carcinoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Colon cancer ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Lung adenocarcinoma metastatic ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Metastases to lung ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Pancreatic carcinoma ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Rectosigmoid cancer ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Laryngeal cancer ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Lung adenocarcinoma ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Tumour associated fever ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Breast cancer ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Gastric cancer ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Metastatic carcinoma of the bladder ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Metastatic gastric cancer ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Nervous system disorders
Haemorrhage intracranial ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	1/6267 (0.02%)	2/6253 (0.03%)
Haemorrhagic stroke ^* 1	1/6312 (0.02%)	3/6254 (0.05%)	2/6267 (0.03%)	1/6253 (0.02%)
Transient ischaemic attack ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	1/6253 (0.02%)
Grand mal convulsion ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Critical illness polyneuropathy ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Optic neuritis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Spinal cord ischaemia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Syncope ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Presyncope ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Convulsion ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Dizziness ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Drop attacks ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Encephalomalacia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Loss of consciousness ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Paraesthesia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Brain stem syndrome ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Carotid artery stenosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Dysarthria ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Headache ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Hypertensive encephalopathy ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Migraine without aura ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Multiple sclerosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Anoxic encephalopathy ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Neurological symptom ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Spinal cord infarction ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Psychiatric disorders
Depression ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Major depression ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Psychotic disorder ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Confusional state ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Delirium ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Anxiety ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Completed suicide ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Generalised anxiety disorder ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Mental status changes ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Post-traumatic stress disorder ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Alcohol withdrawal syndrome ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Bipolar i disorder ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Mental disorder due to a general medical condition ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Suicide attempt ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Renal and urinary disorders
Renal failure acute ^* 1	11/6312 (0.17%)	9/6254 (0.14%)	18/6267 (0.29%)	10/6253 (0.16%)
Renal failure ^* 1	7/6312 (0.11%)	7/6254 (0.11%)	8/6267 (0.13%)	8/6253 (0.13%)
Haematuria ^* 1	5/6312 (0.08%)	4/6254 (0.06%)	4/6267 (0.06%)	5/6253 (0.08%)
Renal failure chronic ^* 1	2/6312 (0.03%)	2/6254 (0.03%)	0/6267 (0.00%)	3/6253 (0.05%)
Calculus ureteric ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	2/6253 (0.03%)
Cystitis haemorrhagic ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Renal colic ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Nephropathy toxic ^* 1	2/6312 (0.03%)	2/6254 (0.03%)	2/6267 (0.03%)	0/6253 (0.00%)
Nephrolithiasis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Renal impairment ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Hydronephrosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Renal cyst ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Nephropathy ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Urethral stenosis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Reproductive system and breast disorders
Menorrhagia ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Ovarian haemorrhage ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Prostatitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^* 1	5/6312 (0.08%)	7/6254 (0.11%)	5/6267 (0.08%)	10/6253 (0.16%)
Atelectasis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	3/6253 (0.05%)
Chronic obstructive pulmonary disease ^* 1	2/6312 (0.03%)	4/6254 (0.06%)	5/6267 (0.08%)	2/6253 (0.03%)
Respiratory failure ^* 1	3/6312 (0.05%)	4/6254 (0.06%)	4/6267 (0.06%)	2/6253 (0.03%)
Pneumothorax ^* 1	5/6312 (0.08%)	1/6254 (0.02%)	2/6267 (0.03%)	2/6253 (0.03%)
Epistaxis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	2/6253 (0.03%)
Haemothorax ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	2/6253 (0.03%)
Respiratory arrest ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	2/6253 (0.03%)
Pleural effusion ^* 1	3/6312 (0.05%)	0/6254 (0.00%)	3/6267 (0.05%)	1/6253 (0.02%)
Acute respiratory distress syndrome ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Pneumonitis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Pneumonia aspiration ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Pulmonary congestion ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Pulmonary oedema ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Haemoptysis ^* 1	1/6312 (0.02%)	2/6254 (0.03%)	0/6267 (0.00%)	1/6253 (0.02%)
Respiratory distress ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Thoracic haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Apnoea ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Lung disorder ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Respiratory depression ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Sleep apnoea syndrome ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Acute respiratory failure ^* 1	1/6312 (0.02%)	2/6254 (0.03%)	2/6267 (0.03%)	0/6253 (0.00%)
Pleural haemorrhage ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	2/6267 (0.03%)	0/6253 (0.00%)
Cough ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Hypoxia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Pulmonary alveolar haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Acute pulmonary oedema ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Pleurisy ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Emphysema ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Idiopathic pulmonary fibrosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Laryngospasm ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Upper respiratory tract congestion ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Dyspnoea ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Skin and subcutaneous tissue disorders
Rash ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	3/6253 (0.05%)
Dermatitis allergic ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Haemorrhage subcutaneous ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Palmar-plantar erythrodysaesthesia syndrome ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Rash maculo-papular ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Angioedema ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Drug eruption ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Urticaria ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Erythema ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Henoch-schonlein purpura ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Skin haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Vascular disorders
Deep vein thrombosis ^* 1	3/6312 (0.05%)	1/6254 (0.02%)	6/6267 (0.10%)	7/6253 (0.11%)
Haemorrhage ^* 1	3/6312 (0.05%)	5/6254 (0.08%)	5/6267 (0.08%)	2/6253 (0.03%)
Hypotension ^* 1	3/6312 (0.05%)	0/6254 (0.00%)	2/6267 (0.03%)	1/6253 (0.02%)
Hypertension ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	2/6267 (0.03%)	1/6253 (0.02%)
Peripheral ischaemia ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	1/6267 (0.02%)	1/6253 (0.02%)
Hypertensive crisis ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	1/6253 (0.02%)
Arterial thrombosis limb ^* 1	0/6312 (0.00%)	2/6254 (0.03%)	0/6267 (0.00%)	1/6253 (0.02%)
Haematoma ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Aortic aneurysm rupture ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	1/6253 (0.02%)
Shock ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Thrombosis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Vena cava thrombosis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Venous thrombosis limb ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	1/6253 (0.02%)
Peripheral embolism ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Peripheral vascular disorder ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	2/6267 (0.03%)	0/6253 (0.00%)
Arteriovenous fistula ^* 1	0/6312 (0.00%)	3/6254 (0.05%)	1/6267 (0.02%)	0/6253 (0.00%)
Aortic dissection ^* 1	2/6312 (0.03%)	1/6254 (0.02%)	1/6267 (0.02%)	0/6253 (0.00%)
Femoral artery occlusion ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Peripheral arterial occlusive disease ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Arterial occlusive disease ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Iliac artery occlusion ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Orthostatic hypotension ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Phlebitis ^* 1	0/6312 (0.00%)	0/6254 (0.00%)	1/6267 (0.02%)	0/6253 (0.00%)
Artery dissection ^* 1	1/6312 (0.02%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Arterial haemorrhage ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Arterial rupture ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Shock haemorrhagic ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Venous thrombosis ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Wound haemorrhage ^* 1	0/6312 (0.00%)	1/6254 (0.02%)	0/6267 (0.00%)	0/6253 (0.00%)
Femoral artery dissection ^* 1	2/6312 (0.03%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
Venous haemorrhage ^* 1	1/6312 (0.02%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA (12.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Clopidogrel 300/75/75 mg + ASA Low Dose	Clopidogrel 300/75/75 mg + ASA High Dose	Clopidogrel 600/150/75 mg + ASA Low Dose	Clopidogrel 600/150/75 mg + ASA High Dose
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6312 (0.00%)	0/6254 (0.00%)	0/6267 (0.00%)	0/6253 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Publication of the study is made jointly in the name of all wholehearted collaborators. Other papers are authored based on the contributions of the individuals to the overall study. Sub-studies with scientific merit which have received prior approvals of the Steering Committee may be published separately in the names of contributing Investigators. A copy of all manuscripts are provided to the Sponsors for their review and the final decision to publish is made by the Steering Committee.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Trial Information Transparency Team
Organization:	sanofi-aventis
EMail:	GV-Contact-us@sanofi-aventis.com

Publications of Results:

CURRENT-OASIS 7 Investigators; Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475. Erratum In: N Engl J Med. 2010 Oct 14;363(16):1585.

Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. doi: 10.1056/NEJMe1008891. No abstract available.

Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.

Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Oct 9;376(9748):1203-5. doi: 10.1016/S0140-6736(10)61262-7. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bossard M, Gao P, Boden W, Steg G, Tanguay JF, Joyner C, Granger CB, Kastrati A, Faxon D, Budaj A, Pais P, Di Pasquale G, Valentin V, Flather M, Moccetti T, Yusuf S, Mehta SR. Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease. Heart. 2021 Nov;107(21):1739-1747. doi: 10.1136/heartjnl-2020-318045. Epub 2021 Jan 27.

Bossard M, Granger CB, Tanguay JF, Montalescot G, Faxon DP, Jolly SS, Widimsky P, Niemela K, Steg PG, Natarajan MK, Gao P, Fox KAA, Yusuf S, Mehta SR. Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Nov 3;6(11):e006577. doi: 10.1161/JAHA.117.006577.

Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. Am Heart J. 2008 Dec;156(6):1080-1088.e1. doi: 10.1016/j.ahj.2008.07.026. Epub 2008 Nov 1.

Layout table for additonal information

Responsible Party:	ICD, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00335452
Other Study ID Numbers:	EFC5965 EUDRACT: 2006-000313-38
First Submitted:	June 8, 2006
First Posted:	June 9, 2006
Results First Submitted:	September 15, 2010
Results First Posted:	October 7, 2010
Last Update Posted:	November 18, 2010

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