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[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] (SOCRATES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994720
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Acute Ischaemic Stroke
Transient Ischaemic Attack
Interventions Drug: ticagrelor
Drug: Acetylsalicylic acid (ASA)
Enrollment 13307
Recruitment Details In total, 13307 patients were enrolled from 674 study sites in 33 countries. The first patient was enrolled on 07 January 2014. The last patient visit took place on 02 March 2016.
Pre-assignment Details Enrolled patients randomised to study drug: 99.2%; n=13199 Patients who were not randomised: 0.8%; n=108 Patients with eligibility criteria not fulfilled: 0.7%; n=93 Patient decision: 0.1%; n=15
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description Ticagrelor 90 mg twice daily (BD) ASA 100 mg once daily (OD)
Period Title: Overall Study
Started 6589 6610
Completed 6543 [1] 6554 [1]
Not Completed 46 56
Reason Not Completed
Withdrawal by Subject             46             56
[1]
Includes patients who did not withdraw informed consent prior to the Study Closure Visit
Arm/Group Title Ticagrelor 90 mg ASA 100 mg Total
Hide Arm/Group Description Ticagrelor 90 mg twice daily (BD) ASA 100 mg once daily (OD) Total of all reporting groups
Overall Number of Baseline Participants 6589 6610 13199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6589 participants 6610 participants 13199 participants
65.8  (11.23) 65.9  (11.37) 65.9  (11.30)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6589 participants 6610 participants 13199 participants
<65 years 3021 3007 6028
Between 65 and 75 years 2064 2112 4176
>75 years 1504 1491 2995
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6589 participants 6610 participants 13199 participants
Female
2759
  41.9%
2724
  41.2%
5483
  41.5%
Male
3830
  58.1%
3886
  58.8%
7716
  58.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6589 participants 6610 participants 13199 participants
Hispanic or Latino
566
   8.6%
558
   8.4%
1124
   8.5%
Not Hispanic or Latino
6023
  91.4%
6050
  91.5%
12073
  91.5%
Unknown or Not Reported
0
   0.0%
2
   0.0%
2
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6589 participants 6610 participants 13199 participants
American Indian or Alaska Native 69 74 143
Asian 1957 1949 3906
Native Hawaiian or Other Pacific Islander 4 1 5
Black or African American 119 120 239
White 4374 4410 8784
Other 66 56 122
1.Primary Outcome
Title Number of Participants With Composite of Stroke/MI/Death
Hide Description Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
442 497
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments Composite of stroke/MI/death
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0670
Comments In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.78 to 1.01
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Ischaemic Stroke
Hide Description Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
385 441
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments Ischemic stroke
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0462
Comments If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.76 to 1.00
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Net Clinical Outcome
Hide Description Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
457 508
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0928
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.79 to 1.02
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Hide Description Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
423 475
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0771
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.78 to 1.01
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With All-Cause Death
Hide Description Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
68 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3641
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.83 to 1.67
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With CV Death
Hide Description Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
41 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4828
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.75 to 1.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With MI
Hide Description Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
25 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5457
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.67 to 2.14
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants by Severity of Stroke and Overall Disability
Hide Description

Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.

Modified Rankin Score:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.

Disability defined as mRS > 1.

Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables.

Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
1107 1194
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1393
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.85 to 1.02
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Stroke
Hide Description Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
390 450
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0342
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.75 to 0.99
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Fatal Stroke
Hide Description Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
18 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8557
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.55 to 2.06
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Disabling Stroke
Hide Description Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the full analysis set, which included all randomized patients.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6589 6610
Measure Type: Number
Unit of Measure: Participants
277 307
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2126
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.77 to 1.06
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in NIHSS
Hide Description

Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):

0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.

Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
NIHSS in patients with an index stroke event
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 4798 4869
Measure Type: Number
Unit of Measure: Participants
<=-5 132 127
-4 403 438
-3 779 810
-2 1088 1073
-1 1099 1131
0 681 683
1 67 79
2 28 31
3 18 16
4 13 11
5 6 6
>5 10 14
Missing 474 450
13.Secondary Outcome
Title EQ-5D at Visit 1 (Enrolment)
Hide Description

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Time Frame Visit 1 (Enrolment)
Hide Outcome Measure Data
Hide Analysis Population Description
Include only results from patients who visit the site in-person.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6497 6512
Mean (Standard Deviation)
Unit of Measure: Index score
0.70  (0.297) 0.70  (0.298)
14.Secondary Outcome
Title EQ-5D at Visit 2 (Day 7+-2d)
Hide Description

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Time Frame Visit 2 (Day 7+-2d)
Hide Outcome Measure Data
Hide Analysis Population Description
Include only results from patients who visit the site in-person.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 5883 5909
Mean (Standard Deviation)
Unit of Measure: Index score
0.80  (0.244) 0.79  (0.262)
15.Secondary Outcome
Title EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
Hide Description

EQ-5D index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Time Frame End of treatment visit (Day 90+-7d)
Hide Outcome Measure Data
Hide Analysis Population Description
Include only results from patients who visit the site in-person.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 5817 5893
Mean (Standard Deviation)
Unit of Measure: Index score
0.85  (0.203) 0.84  (0.208)
16.Secondary Outcome
Title EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
Hide Description

EQ-5D index score using the UK tariff.

EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Time Frame Premature treatment discontinuation visit(<15 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 787 633
Mean (Standard Deviation)
Unit of Measure: Index score
0.72  (0.330) 0.68  (0.364)
17.Secondary Outcome
Title Number of Participants With PLATO Major Bleeding Event
Hide Description

Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

PLATO Major bleeding is defined as a bleed that is any one of:

  • Fatal
  • Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)
  • Intrapericardial bleed with cardiac tamponade
  • Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery
  • Significantly disabling (eg. intraocular with permanent vision loss)
  • Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)
  • Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.
Time Frame From randomization up to 97 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6549 6581
Measure Type: Number
Unit of Measure: Participants
31 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments PLATO Major bleeding
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4511
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.52 to 1.34
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Hide Description Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
Time Frame Time from first dose and up to and including 7 days following the date of last dose of the study
Hide Outcome Measure Data
Hide Analysis Population Description
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.
Arm/Group Title Ticagrelor 90 mg ASA 100 mg
Hide Arm/Group Description:
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg once daily (OD)
Overall Number of Participants Analyzed 6549 6581
Measure Type: Number
Unit of Measure: Participants
82 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 90 mg, ASA 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
1.53 to 3.34
Estimation Comments [Not Specified]
Time Frame On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
Adverse Event Reporting Description

The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.

These patients totaled 6549 for ticagrelor and 6581 for ASA.

 
Arm/Group Title ASA 100mg Ticagrelor 90mg
Hide Arm/Group Description ASA 100 mg once daily (OD) Ticagrelor 90 mg twice daily (BD)
All-Cause Mortality
ASA 100mg Ticagrelor 90mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ASA 100mg Ticagrelor 90mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   533/6581 (8.10%)      532/6549 (8.12%)    
Blood and lymphatic system disorders     
Anaemia  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Antiphospholipid syndrome  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hypochromic anaemia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Iron deficiency anaemia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Leukocytosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Lymphadenopathy  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Thrombocytopenia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Thrombocytosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cardiac disorders     
Acute left ventricular failure  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Angina pectoris  1  3/6581 (0.05%)  3 3/6549 (0.05%)  3
Angina unstable  1  4/6581 (0.06%)  4 11/6549 (0.17%)  11
Aortic valve stenosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Arteriosclerosis coronary artery  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Atrial fibrillation  1  21/6581 (0.32%)  21 24/6549 (0.37%)  25
Atrial flutter  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Atrial thrombosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Atrioventricular block complete  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Atrioventricular block second degree  1  2/6581 (0.03%)  2 6/6549 (0.09%)  6
Bradyarrhythmia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Bradycardia  1  3/6581 (0.05%)  3 1/6549 (0.02%)  1
Cardiac failure  1  7/6581 (0.11%)  7 7/6549 (0.11%)  7
Cardiac failure acute  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Cardiac failure congestive  1  2/6581 (0.03%)  3 1/6549 (0.02%)  1
Cardiac ventricular thrombosis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Cardio-respiratory arrest  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cardiopulmonary failure  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Congestive cardiomyopathy  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Coronary artery disease  1  3/6581 (0.05%)  3 2/6549 (0.03%)  2
Coronary artery stenosis  1  4/6581 (0.06%)  4 4/6549 (0.06%)  4
Hypertensive heart disease  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intracardiac mass  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intracardiac thrombus  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Ischaemic cardiomyopathy  1  0/6581 (0.00%)  0 3/6549 (0.05%)  3
Left ventricular failure  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Mitral valve disease  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Myocardial ischaemia  1  1/6581 (0.02%)  1 4/6549 (0.06%)  4
Pericardial effusion  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pericarditis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Right ventricular failure  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Sinus arrest  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Sinus node dysfunction  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Supraventricular tachycardia  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Tachycardia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Ventricular asystole  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Ventricular tachycardia  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Congenital, familial and genetic disorders     
Atrial septal defect  1  6/6581 (0.09%)  6 3/6549 (0.05%)  3
Ear and labyrinth disorders     
Deafness permanent  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Vertigo  1  3/6581 (0.05%)  3 3/6549 (0.05%)  3
Vertigo positional  1  4/6581 (0.06%)  5 2/6549 (0.03%)  2
Eye disorders     
Conjunctival haemorrhage  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Diabetic retinopathy  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intraocular haematoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Optic neuropathy  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Retinal haemorrhage  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Vision blurred  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Visual acuity reduced  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Vitreous detachment  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Vitreous haemorrhage  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Chronic gastritis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Diarrhoea  1  3/6581 (0.05%)  3 2/6549 (0.03%)  2
Diverticulum intestinal  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Diverticulum intestinal haemorrhagic  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Duodenal ulcer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Duodenal ulcer haemorrhage  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Dyspepsia  1  1/6581 (0.02%)  1 3/6549 (0.05%)  4
Dysphagia  1  3/6581 (0.05%)  3 0/6549 (0.00%)  0
Enteritis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Enterocolitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Gastric haemorrhage  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Gastric ulcer  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Gastric ulcer haemorrhage  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Gastric ulcer perforation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Gastritis  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Gastritis erosive  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Gastritis haemorrhagic  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Gastrointestinal haemorrhage  1  5/6581 (0.08%)  5 2/6549 (0.03%)  2
Gastrooesophageal reflux disease  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Haemorrhagic erosive gastritis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Haemorrhoids  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Ileus  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Incarcerated inguinal hernia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Inguinal hernia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Intestinal haemorrhage  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intestinal obstruction  1  2/6581 (0.03%)  2 1/6549 (0.02%)  2
Intestinal perforation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Lower gastrointestinal haemorrhage  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Mallory-Weiss syndrome  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Nausea  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Oesophagitis haemorrhagic  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Pancreatitis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Pancreatitis acute  1  4/6581 (0.06%)  4 0/6549 (0.00%)  0
Rectal haemorrhage  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Small intestinal obstruction  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Upper gastrointestinal haemorrhage  1  3/6581 (0.05%)  3 2/6549 (0.03%)  2
Vomiting  1  2/6581 (0.03%)  2 3/6549 (0.05%)  3
General disorders     
Asthenia  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Chest pain  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Fatigue  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Generalised oedema  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Malaise  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Multi-organ failure  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Non-cardiac chest pain  1  7/6581 (0.11%)  8 5/6549 (0.08%)  5
Pyrexia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Hepatobiliary disorders     
Bile duct stone  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Cholecystitis  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Cholecystitis acute  1  5/6581 (0.08%)  5 3/6549 (0.05%)  3
Cholecystitis chronic  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cholelithiasis  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Drug-induced liver injury  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Hepatic function abnormal  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Hepatocellular injury  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Hepatotoxicity  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Jaundice  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Immune system disorders     
Anaphylactic shock  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Infections and infestations     
Abscess limb  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Acute endocarditis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Acute hepatitis C  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Acute sinusitis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Appendiceal abscess  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Biliary sepsis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Biliary tract infection  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Bronchitis  1  2/6581 (0.03%)  2 3/6549 (0.05%)  3
Cellulitis  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Clostridial infection  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Device related infection  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Diabetic gangrene  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Diverticulitis  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Encephalitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Endocarditis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Endophthalmitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Epididymitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Erysipelas  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Gangrene  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Gastroenteritis  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Gastroenteritis viral  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Gastrointestinal infection  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Hepatitis B  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Herpes zoster  1  0/6581 (0.00%)  0 3/6549 (0.05%)  3
Influenza  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Kidney infection  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Lung infection  1  5/6581 (0.08%)  5 1/6549 (0.02%)  1
Lyme disease  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Meningoencephalitis herpetic  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Neuroborreliosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Osteomyelitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Otosalpingitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pneumonia  1  23/6581 (0.35%)  25 19/6549 (0.29%)  19
Pneumonia influenzal  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Postoperative wound infection  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pseudomembranous colitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pulmonary tuberculosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Pyelonephritis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Pyelonephritis acute  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Respiratory tract infection  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Sepsis  1  1/6581 (0.02%)  1 4/6549 (0.06%)  4
Septic shock  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Sinusitis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Staphylococcal bacteraemia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Subdural empyema  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Upper respiratory tract infection  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Urinary tract infection  1  4/6581 (0.06%)  4 8/6549 (0.12%)  8
Urosepsis  1  0/6581 (0.00%)  0 4/6549 (0.06%)  4
Vestibular neuronitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Wound infection  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Back injury  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Clavicle fracture  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Compression fracture  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Craniocerebral injury  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Extradural haematoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Facial bones fracture  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Fall  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Femoral neck fracture  1  4/6581 (0.06%)  4 1/6549 (0.02%)  1
Femur fracture  1  4/6581 (0.06%)  4 1/6549 (0.02%)  1
Forearm fracture  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Head injury  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Hip fracture  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Intentional overdose  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Joint dislocation  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Ligament sprain  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Lower limb fracture  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Lumbar vertebral fracture  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Nerve root injury  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Pelvic fracture  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Post procedural haematoma  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Post procedural haematuria  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Procedural haemorrhage  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pubis fracture  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Rib fracture  1  4/6581 (0.06%)  4 1/6549 (0.02%)  1
Spinal compression fracture  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Spinal fracture  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Subdural haematoma  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Tendon injury  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Toxicity to various agents  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Traumatic haematoma  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Traumatic haemothorax  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Traumatic intracranial haemorrhage  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Wound necrosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Wrist fracture  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Aspartate aminotransferase increased  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Blood creatinine increased  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Blood urea increased  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Cardiac function test abnormal  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Flavivirus test positive  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Haemoglobin decreased  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Platelet count increased  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Transaminases increased  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
White blood cell count decreased  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Dehydration  1  5/6581 (0.08%)  5 0/6549 (0.00%)  0
Diabetes mellitus  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Diabetes mellitus inadequate control  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Diabetic metabolic decompensation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Gout  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Hypercalcaemia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hyperglycaemia  1  3/6581 (0.05%)  3 1/6549 (0.02%)  1
Hypoglycaemia  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Hyponatraemia  1  4/6581 (0.06%)  4 3/6549 (0.05%)  3
Hypovolaemia  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Tetany  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Type 2 diabetes mellitus  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Arthritis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Chondrocalcinosis pyrophosphate  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Foot deformity  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intervertebral disc degeneration  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Intervertebral disc disorder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intervertebral disc protrusion  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Lumbar spinal stenosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Muscular weakness  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Musculoskeletal chest pain  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Musculoskeletal pain  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Myalgia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Periostitis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Rheumatoid arthritis  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Spinal column stenosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Spinal osteoarthritis  1  0/6581 (0.00%)  0 3/6549 (0.05%)  3
Spinal pain  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Sympathetic posterior cervical syndrome  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Synovial cyst  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Anaplastic astrocytoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Basal cell carcinoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Bladder cancer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Bladder cancer recurrent  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Brain neoplasm  1  1/6581 (0.02%)  1 4/6549 (0.06%)  4
Breast cancer female  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cardiac myxoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Cardiac neoplasm unspecified  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Cardiac valve fibroelastoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Central nervous system neoplasm  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Clear cell renal cell carcinoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Colon cancer  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Colon neoplasm  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Endometrial adenocarcinoma  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Extraskeletal myxoid chondrosarcoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Gastric cancer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Glioblastoma  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Glioma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hepatic cancer  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hepatocellular carcinoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Leukaemia recurrent  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Lung adenocarcinoma  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Lung cancer metastatic  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Lung neoplasm  1  3/6581 (0.05%)  3 1/6549 (0.02%)  1
Lung neoplasm malignant  1  3/6581 (0.05%)  3 3/6549 (0.05%)  3
Metastases to central nervous system  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Metastases to liver  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Metastases to spine  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Nodular melanoma  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Ocular neoplasm  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Oesophageal carcinoma  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Ovarian neoplasm  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pancreatic carcinoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Pancreatic carcinoma metastatic  1  3/6581 (0.05%)  3 0/6549 (0.00%)  0
Pituitary tumour benign  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Plasma cell myeloma  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Polycythaemia vera  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Prostate cancer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Rectal adenoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Rectal cancer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Renal cancer  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Renal cell carcinoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Renal neoplasm  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Squamous cell carcinoma of lung  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Thyroid cancer  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/6581 (0.02%)  2 2/6549 (0.03%)  2
Basilar artery stenosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Capsular warning syndrome  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Carotid arteriosclerosis  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Carotid artery aneurysm  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Carotid artery dissection  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Carotid artery occlusion  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Carotid artery stenosis  1  27/6581 (0.41%)  27 28/6549 (0.43%)  28
Carotid artery thrombosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Carotid sinus syndrome  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Cerebral amyloid angiopathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cerebral artery occlusion  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cerebral haemorrhage  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Cerebral infarction  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Cerebrovascular accident  1  3/6581 (0.05%)  3 2/6549 (0.03%)  2
Cerebrovascular disorder  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Cervicobrachial syndrome  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Clumsiness  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Dementia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Depressed level of consciousness  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Diabetic neuropathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Dizziness  1  3/6581 (0.05%)  3 6/6549 (0.09%)  6
Dysaesthesia  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Dysarthria  1  3/6581 (0.05%)  3 1/6549 (0.02%)  1
Encephalopathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Epilepsy  1  1/6581 (0.02%)  1 4/6549 (0.06%)  5
Facial paresis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Generalised tonic-clonic seizure  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Haemorrhage intracranial  1  4/6581 (0.06%)  4 0/6549 (0.00%)  0
Haemorrhagic stroke  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Haemorrhagic transformation stroke  1  6/6581 (0.09%)  6 2/6549 (0.03%)  2
Headache  1  5/6581 (0.08%)  5 1/6549 (0.02%)  1
Hemianopia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hemiparesis  1  4/6581 (0.06%)  5 1/6549 (0.02%)  1
Hemiplegia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Hypertensive encephalopathy  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Hypoaesthesia  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Internal carotid artery kinking  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Intracranial aneurysm  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Intracranial haematoma  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Intracranial venous sinus thrombosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Ischaemic stroke  1  7/6581 (0.11%)  7 5/6549 (0.08%)  5
Loss of consciousness  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Lumbosacral radiculopathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Meningeal disorder  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Metabolic encephalopathy  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Migraine  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Migraine with aura  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Mononeuropathy  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Monoparesis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Multiple sclerosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Neurodegenerative disorder  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Neurological decompensation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Neurological symptom  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Paraesthesia  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Partial seizures  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Presyncope  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Reversible ischaemic neurological deficit  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Sciatica  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Seizure  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Spinal claudication  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Status epilepticus  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Stroke in evolution  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Subarachnoid haemorrhage  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Syncope  1  2/6581 (0.03%)  2 6/6549 (0.09%)  6
Tension headache  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Toxic encephalopathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Transient ischaemic attack  1  68/6581 (1.03%)  74 55/6549 (0.84%)  57
Tremor  1  1/6581 (0.02%)  2 0/6549 (0.00%)  0
Trigeminal nerve disorder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
VIIth nerve paralysis  1  5/6581 (0.08%)  5 1/6549 (0.02%)  1
Vascular encephalopathy  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Vasculitis cerebral  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Vocal cord paresis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Anxiety  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Anxiety disorder  1  1/6581 (0.02%)  1 3/6549 (0.05%)  3
Bipolar disorder  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Confusional state  1  4/6581 (0.06%)  4 1/6549 (0.02%)  1
Depression  1  4/6581 (0.06%)  4 2/6549 (0.03%)  2
Disorientation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Generalised anxiety disorder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hallucination  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Major depression  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Nervousness  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Personality disorder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Psychiatric decompensation  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Somatoform disorder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  7/6581 (0.11%)  7 6/6549 (0.09%)  6
Calculus bladder  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Calculus ureteric  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Cystitis noninfective  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Haematuria  1  5/6581 (0.08%)  5 2/6549 (0.03%)  2
Hydronephrosis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Malacoplakia vesicae  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Nephritis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Nephrolithiasis  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Pelvi-ureteric obstruction  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Renal cyst haemorrhage  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Renal failure  1  2/6581 (0.03%)  2 2/6549 (0.03%)  2
Renal impairment  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Tubulointerstitial nephritis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Urinary retention  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Menorrhagia  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Metrorrhagia  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Prostatitis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Vaginal haemorrhage  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Asthma  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Chronic obstructive pulmonary disease  1  5/6581 (0.08%)  6 1/6549 (0.02%)  1
Chronic respiratory failure  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Dyspnoea  1  1/6581 (0.02%)  1 11/6549 (0.17%)  11
Epistaxis  1  1/6581 (0.02%)  1 2/6549 (0.03%)  2
Haemoptysis  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Hypoxia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Interstitial lung disease  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Laryngeal oedema  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Platypnoea  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pneumonia aspiration  1  3/6581 (0.05%)  3 3/6549 (0.05%)  3
Pneumothorax  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pulmonary embolism  1  10/6581 (0.15%)  10 4/6549 (0.06%)  4
Pulmonary mass  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Pulmonary oedema  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Pulmonary sarcoidosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Respiratory arrest  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Respiratory failure  1  3/6581 (0.05%)  3 1/6549 (0.02%)  1
Sleep apnoea syndrome  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Tracheal stenosis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Dermatitis allergic  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Ecchymosis  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Eczema  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Rash  1  0/6581 (0.00%)  0 3/6549 (0.05%)  3
Rash papular  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Swelling face  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Urticaria  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Vascular disorders     
Accelerated hypertension  1  0/6581 (0.00%)  0 1/6549 (0.02%)  2
Aortic aneurysm  1  2/6581 (0.03%)  2 1/6549 (0.02%)  1
Aortic aneurysm rupture  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Aortic dissection  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Blood pressure fluctuation  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Blood pressure inadequately controlled  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Circulatory collapse  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Deep vein thrombosis  1  2/6581 (0.03%)  2 3/6549 (0.05%)  3
Haemorrhagic infarction  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hypertension  1  11/6581 (0.17%)  11 12/6549 (0.18%)  13
Hypertensive crisis  1  7/6581 (0.11%)  7 7/6549 (0.11%)  7
Hypertensive emergency  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Hypotension  1  0/6581 (0.00%)  0 2/6549 (0.03%)  2
Ischaemia  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Leriche syndrome  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Peripheral artery aneurysm  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Peripheral artery thrombosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Peripheral ischaemia  1  1/6581 (0.02%)  1 1/6549 (0.02%)  1
Phlebitis  1  2/6581 (0.03%)  2 0/6549 (0.00%)  0
Subclavian artery aneurysm  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Subclavian artery stenosis  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Thrombophlebitis  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Thrombophlebitis superficial  1  1/6581 (0.02%)  1 0/6549 (0.00%)  0
Venous thrombosis limb  1  0/6581 (0.00%)  0 1/6549 (0.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ASA 100mg Ticagrelor 90mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/6581 (1.29%)      383/6549 (5.85%)    
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  85/6581 (1.29%)  86 383/6549 (5.85%)  425
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brilinta Global Clinical Lead
Organization: AstraZeneca R&D
Phone: +46 31 776 10 00
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01994720     History of Changes
Other Study ID Numbers: D5134C00001
2012-003895-38 ( EudraCT Number )
First Submitted: November 18, 2013
First Posted: November 26, 2013
Results First Submitted: March 7, 2017
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017