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A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

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: NCT02415400
Recruitment Status : Completed
First Posted : April 14, 2015
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Pfizer
Duke Clinical Research Institute
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Acute Coronary Syndromes
Interventions Drug: Apixaban
Drug: vitamin K antagonist
Drug: Acetylsalicylic acid
Other: Acetylsalicylic acid placebo
Enrollment 4614
Recruitment Details  
Pre-assignment Details 4683 participants enrolled, 4614 randomized. Reasons not randomized: 2 adverse event; 1 request to stop therapy; 12 withdrew consent; 1 lost to follow-up; 1 poor/non-compliance; 35 no longer met criteria; 2 admin reasons by Sponsor; 10 lack of IP at site; 1 IWRS down; 2 physician recommended; 1 leaving the country; 1 pharmacogenetic sample positive
Arm/Group Title Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic Acid VKA With Placebo Matching Acetylsalicylic Acid
Hide Arm/Group Description 5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy 5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Period Title: Overall Study
Started [1] 1153 1153 1154 1154
Completed [2] 1087 1091 1069 1071
Not Completed 66 62 85 83
Reason Not Completed
Adverse Event             0             1             1             2
Participant request to stop therapy             4             3             8             6
Participant withdrew consent             14             12             30             21
Death             39             41             35             42
Lost to Follow-up             3             3             2             5
Poor/Non-Compliance             0             1             3             4
Participant no longer meets criteria             2             0             0             1
Participant doesn't answer phone             1             0             0             0
Participant wanted home visits             1             0             0             0
Randomized in error             2             0             0             0
No study drug on site             0             1             0             0
Stroke and stroke rehabilitation             0             0             1             0
Coagulation values cannot be set             0             0             1             0
State regulations prevent participation             0             0             1             0
Poor treatment monitoring             0             0             1             0
Participant in jail             0             0             1             0
Investigator decision             0             0             1             1
Site closure; participant won't transfer             0             0             0             1
[1]
Started = Randomized
[2]
Completed = Completing the period
Arm/Group Title Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic VKA With Placebo Matching Acetylsalicylic Acid Total
Hide Arm/Group Description 5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy 5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy Total of all reporting groups
Overall Number of Baseline Participants 1153 1153 1154 1154 4614
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1153 participants 1153 participants 1154 participants 1154 participants 4614 participants
70.2  (9.12) 69.3  (9.32) 70.0  (9.09) 70.0  (9.13) 69.9  (9.17)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1153 participants 1153 participants 1154 participants 1154 participants 4614 participants
< 65 years old 308 333 311 315 1267
65-80 years old 664 660 662 657 2643
>=80 181 160 181 182 704
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1153 participants 1153 participants 1154 participants 1154 participants 4614 participants
Female
357
  31.0%
313
  27.1%
339
  29.4%
328
  28.4%
1337
  29.0%
Male
796
  69.0%
840
  72.9%
815
  70.6%
826
  71.6%
3277
  71.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1153 participants 1153 participants 1154 participants 1154 participants 4614 participants
Hispanic or Latino
2
   0.2%
10
   0.9%
7
   0.6%
5
   0.4%
24
   0.5%
Not Hispanic or Latino
114
   9.9%
123
  10.7%
120
  10.4%
126
  10.9%
483
  10.5%
Unknown or Not Reported
1037
  89.9%
1020
  88.5%
1027
  89.0%
1023
  88.6%
4107
  89.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1153 participants 1153 participants 1154 participants 1154 participants 4614 participants
White 1039 1058 1043 1044 4184
Black/African American 17 12 12 18 59
Asian 35 35 39 31 140
American Indian/Alaska Native 4 6 2 4 16
Native Hawaiian/Other Pacific Islander 0 0 0 1 1
Other 47 29 38 43 157
Not Reported 11 13 20 13 57
[1]
Measure Description: Table is for category of Race.
1.Primary Outcome
Title The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
Hide Description

Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants treated with Apixaban or VKA.

Assessment is only for the Apixaban and VKA interventions.

Arm/Group Title Apixaban Vitamin K Antagonist
Hide Arm/Group Description:
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2290 2259
Measure Type: Number
Unit of Measure: Percentage per year
24.66 35.79
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Vitamin K Antagonist
Comments Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.
Type of Statistical Test Non-Inferiority
Comments Non-Inferiority (NI) margin = 1.2
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sided p-value for NI test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apixaban, Vitamin K Antagonist
Comments Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 2-sided p-value for superiority test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.58 to 0.82
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
Hide Description

Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.

N is the number of participants with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants treated with aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Arm/Group Title Acetylsalicylic Acid Film Coated Tablet Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Hide Arm/Group Description:
81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2277 2279
Measure Type: Number
Unit of Measure: Percentage per year
40.51 21.03
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetylsalicylic Acid Film Coated Tablet, Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Comments Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 2-sided p-value for superiority test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.58 to 2.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
Hide Description

Time to first occurrence during the time the participants were treated with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants treated with Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Arm/Group Title Apixaban Vitamin K Antagonist
Hide Arm/Group Description:
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2290 2259
Measure Type: Number
Unit of Measure: Percentage per year
24.66 35.79
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Vitamin K Antagonist
Comments Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 2-sided p-value for superiority test
Comments [Not Specified]
4.Secondary Outcome
Title The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
Hide Description

Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants randomized to Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Arm/Group Title Apixaban Vitamin K Antagonist
Hide Arm/Group Description:
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2306 2308
Measure Type: Number
Unit of Measure: Percentage per year
57.24 69.19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Vitamin K Antagonist
Comments Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method 2-sided p-value
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.75 to 0.94
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
Hide Description

Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.

N is the number of participants treated with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants randomized to aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Arm/Group Title Acetylsalicylic Acid Film Coated Tablet Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Hide Arm/Group Description:
81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2307 2307
Measure Type: Number
Unit of Measure: Percentage per year
65.72 60.56
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetylsalicylic Acid Film Coated Tablet, Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Comments Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2219
Comments [Not Specified]
Method 2-sided p-value
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.96 to 1.20
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
Hide Description

Time to first occurrence during the 6-month treatment period with Apixaban or VKA.

N is the number of participants treated with Apixaban or VKA.

n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.

Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants randomized to Apixaban or VKA.

Assessment is only for the Apixaban or VKA interventions.

Arm/Group Title Apixaban Vitamin K Antagonist
Hide Arm/Group Description:
5 mg or 2.5 mg Apixaban tablets orally twice per day with concomitant P2Y12 inhibitor therapy
VKA tablets orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2306 2308
Measure Type: Number
Unit of Measure: Percentage per year
15.85 17.17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Vitamin K Antagonist
Comments Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4370
Comments [Not Specified]
Method 2-sided p-value
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.75 to 1.13
Estimation Comments [Not Specified]
7.Secondary Outcome
Title The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
Hide Description

Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.

N is the number of participants treated with aspirin or placebo.

n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.

Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

Time Frame Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants randomized to aspirin or placebo.

Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions.

Arm/Group Title Acetylsalicylic Acid Film Coated Tablet Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Hide Arm/Group Description:
81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy
Overall Number of Participants Analyzed 2307 2307
Measure Type: Number
Unit of Measure: Percentage per year
15.28 17.73
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetylsalicylic Acid Film Coated Tablet, Placebo Matching Acetylsalicylic Acid Film Coated Tablet
Comments Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1742
Comments [Not Specified]
Method 2-sided p-value
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.70 to 1.07
Estimation Comments [Not Specified]
Time Frame Includes adverse events (AEs) with onset on or after the first dose of study medication through 2 days (for non-serious AE) or 30 days (for serious AE) after the last dose of study medication (approximately 7 months).
Adverse Event Reporting Description Note: Within the VKA/placebo arm, 1 participant was enrolled but died prior to dosing and is included only within the All-Cause Mortality table below.
 
Arm/Group Title Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic Acid VKA With Placebo Matching Acetylsalicylic Acid APIXABAN ONLY VKA ONLY ACETYLSALICLIC ACID ONLY PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
Hide Arm/Group Description 5 mg or 2.5 mg Apixaban tablets orally twice per day with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy 5 mg or 2.5 mg Apixaban tablets orally twice per day with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with 81 mg Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy VKA tablets orally once daily with placebo matching Acetylsalicylic acid film coated tablet orally once daily with concomitant P2Y12 inhibitor therapy Only Apixaban intervention received: 5 mg or 2.5 mg Apixaban tablets orally twice per day Only VKA intervention received: VKA tablets orally once daily Only acetylsalicylic acid intervention received: 81 mg Acetylsalicylic acid film coated tablet orally once daily Only placebo matching acetylsalicylic acid intervention received: placebo matching Acetylsalicylic acid film coated tablet orally once daily
All-Cause Mortality
Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic Acid VKA With Placebo Matching Acetylsalicylic Acid APIXABAN ONLY VKA ONLY ACETYLSALICLIC ACID ONLY PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/1145 (3.67%)   46/1143 (4.02%)   38/1123 (3.38%)   42/1127 (3.73%)   0/2 (0.00%)   3/10 (30.00%)   0/9 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic Acid VKA With Placebo Matching Acetylsalicylic Acid APIXABAN ONLY VKA ONLY ACETYLSALICLIC ACID ONLY PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/1145 (4.63%)   50/1143 (4.37%)   52/1123 (4.63%)   55/1126 (4.88%)   0/2 (0.00%)   3/10 (30.00%)   0/9 (0.00%)   0/10 (0.00%) 
Blood and lymphatic system disorders                 
Anaemia  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Haemorrhagic anaemia  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac disorders                 
Acute coronary syndrome  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Acute myocardial infarction  1  3/1145 (0.26%)  1/1143 (0.09%)  6/1123 (0.53%)  3/1126 (0.27%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Angina pectoris  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Angina unstable  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Arrhythmia  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Atrial flutter  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac arrest  1  2/1145 (0.17%)  3/1143 (0.26%)  3/1123 (0.27%)  3/1126 (0.27%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac failure  1  1/1145 (0.09%)  9/1143 (0.79%)  5/1123 (0.45%)  3/1126 (0.27%)  0/2 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac failure acute  1  1/1145 (0.09%)  2/1143 (0.17%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac failure chronic  1  1/1145 (0.09%)  1/1143 (0.09%)  0/1123 (0.00%)  3/1126 (0.27%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiac failure congestive  1  1/1145 (0.09%)  1/1143 (0.09%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardio-respiratory arrest  1  0/1145 (0.00%)  1/1143 (0.09%)  1/1123 (0.09%)  3/1126 (0.27%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiogenic shock  1  2/1145 (0.17%)  2/1143 (0.17%)  2/1123 (0.18%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiomyopathy  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cardiovascular disorder  1  0/1145 (0.00%)  1/1143 (0.09%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Coronary artery disease  1  1/1145 (0.09%)  0/1143 (0.00%)  1/1123 (0.09%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Myocardial infarction  1  4/1145 (0.35%)  5/1143 (0.44%)  5/1123 (0.45%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Myocardial ischaemia  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Ventricular arrhythmia  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Ventricular fibrillation  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Crohn's disease  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Duodenal ulcer  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Gastritis erosive  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Gastrointestinal haemorrhage  1  1/1145 (0.09%)  1/1143 (0.09%)  2/1123 (0.18%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Intestinal ischaemia  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Melaena  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Mesenteric artery thrombosis  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Rectal haemorrhage  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
General disorders                 
Cardiac death  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Death  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Multimorbidity  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Multiple organ dysfunction syndrome  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Sudden cardiac death  1  2/1145 (0.17%)  2/1143 (0.17%)  1/1123 (0.09%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Sudden death  1  5/1145 (0.44%)  3/1143 (0.26%)  2/1123 (0.18%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Hepatobiliary disorders                 
Hepatotoxicity  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Jaundice  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Liver injury  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Infections and infestations                 
Meningoencephalitis bacterial  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pneumonia  1  1/1145 (0.09%)  1/1143 (0.09%)  2/1123 (0.18%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pneumonia bacterial  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Sepsis  1  1/1145 (0.09%)  2/1143 (0.17%)  1/1123 (0.09%)  3/1126 (0.27%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Septic shock  1  3/1145 (0.26%)  1/1143 (0.09%)  1/1123 (0.09%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Staphylococcal bacteraemia  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications                 
Accidental overdose  1  1/1145 (0.09%)  1/1143 (0.09%)  1/1123 (0.09%)  4/1126 (0.36%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Brain herniation  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Overdose  1  2/1145 (0.17%)  0/1143 (0.00%)  5/1123 (0.45%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Investigations                 
International normalised ratio increased  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Glioblastoma  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Lip squamous cell carcinoma  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Lung neoplasm malignant  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Malignant neoplasm progression  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Neoplasm malignant  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pancreatic carcinoma  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Prostate cancer  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Renal cancer stage IV  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Nervous system disorders                 
Brain injury  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cerebral haemorrhage  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  2/1126 (0.18%)  0/2 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cerebral infarction  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Cerebrovascular accident  1  1/1145 (0.09%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Haemorrhagic stroke  1  1/1145 (0.09%)  1/1143 (0.09%)  0/1123 (0.00%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Ischaemic stroke  1  0/1145 (0.00%)  0/1143 (0.00%)  3/1123 (0.27%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Loss of consciousness  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Status epilepticus  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Psychiatric disorders                 
Confusional state  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Renal and urinary disorders                 
Calculus urinary  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Renal failure  1  0/1145 (0.00%)  2/1143 (0.17%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Acute pulmonary oedema  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Dyspnoea  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Epistaxis  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Lung disorder  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pulmonary embolism  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pulmonary hypertension  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Pulmonary oedema  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Respiratory arrest  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Respiratory failure  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Vascular disorders                 
Aortic aneurysm  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Haemorrhage  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Hypotension  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Peripheral ischaemia  1  1/1145 (0.09%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%) 
Shock  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
Shock haemorrhagic  1  0/1145 (0.00%)  1/1143 (0.09%)  0/1123 (0.00%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apixaban With Acetylsalicylic Acid Film Coated Tablet Apixaban With Placebo Matching Acetylsalicylic Acid Vitamin K Antagonist (VKA) With Acetylsalicylic Acid VKA With Placebo Matching Acetylsalicylic Acid APIXABAN ONLY VKA ONLY ACETYLSALICLIC ACID ONLY PLACEBO MATCHING ACETYLSALICLIC ACID ONLY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/1145 (3.06%)   21/1143 (1.84%)   33/1123 (2.94%)   18/1126 (1.60%)   0/2 (0.00%)   1/10 (10.00%)   3/9 (33.33%)   0/10 (0.00%) 
Blood and lymphatic system disorders                 
Anaemia  1  16/1145 (1.40%)  3/1143 (0.26%)  10/1123 (0.89%)  6/1126 (0.53%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
Cardiac disorders                 
Cardiac failure  1  8/1145 (0.70%)  8/1143 (0.70%)  9/1123 (0.80%)  5/1126 (0.44%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
General disorders                 
Puncture site reaction  1  0/1145 (0.00%)  0/1143 (0.00%)  0/1123 (0.00%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
Infections and infestations                 
Pneumonia  1  5/1145 (0.44%)  1/1143 (0.09%)  2/1123 (0.18%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
Injury, poisoning and procedural complications                 
Vascular pseudoaneurysm  1  0/1145 (0.00%)  0/1143 (0.00%)  1/1123 (0.09%)  0/1126 (0.00%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
Renal and urinary disorders                 
Acute kidney injury  1  9/1145 (0.79%)  3/1143 (0.26%)  5/1123 (0.45%)  2/1126 (0.18%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
Haematuria  1  2/1145 (0.17%)  3/1143 (0.26%)  5/1123 (0.45%)  3/1126 (0.27%)  0/2 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/10 (0.00%) 
Vascular disorders                 
Haematoma  1  4/1145 (0.35%)  3/1143 (0.26%)  6/1123 (0.53%)  1/1126 (0.09%)  0/2 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email:
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02415400    
Other Study ID Numbers: CV185-316
2014-002004-24 ( EudraCT Number )
First Submitted: April 9, 2015
First Posted: April 14, 2015
Results First Submitted: November 7, 2019
Results First Posted: February 7, 2020
Last Update Posted: February 7, 2020