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Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

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ClinicalTrials.gov Identifier: NCT01776424
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prevention & Control
Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Aspirin
Drug: Aspirin placebo
Drug: Rivaroxaban placebo
Drug: Pantoprazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted at 602 centers with randomized participants in 33 countries between 28 Feb 2013 (first patient first visit) and 18 Jul 2017 (last patient last visit for antithrombotic part).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 29872 participants were screened, of which 2477 participants were screen failures. A total of 27395 participants were randomized to one of the study treatment arms.

Reporting Groups
  Description
Rivaroxaban 2.5mg + Aspirin 100mg Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
Rivaroxaban 5mg + Aspirin Placebo Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
Rivaroxaban Placebo + Aspirin 100mg Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.

Participant Flow:   Overall Study
    Rivaroxaban 2.5mg + Aspirin 100mg   Rivaroxaban 5mg + Aspirin Placebo   Rivaroxaban Placebo + Aspirin 100mg
STARTED [1]   9152   9117   9126 
Treated   9134   9110   9107 
COMPLETED   9132   9098   9102 
NOT COMPLETED   20   19   24 
Lost to Follow-up                10                8                9 
Withdrawal by Subject                10                11                15 
[1] Intention-to-treat (ITT) analysis set



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivaroxaban 2.5mg + Aspirin 100mg Participants received Rivaroxaban 2.5 mg twice daily (bid) and Aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
Rivaroxaban 5mg + Aspirin Placebo Participants received Rivaroxaban 5 mg bid and Aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
Rivaroxaban Placebo + Aspirin 100mg Participants received Rivaroxaban placebo bid and Aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. The pantoprazole/placebo part of the study is ongoing.
Total Total of all reporting groups

Baseline Measures
   Rivaroxaban 2.5mg + Aspirin 100mg   Rivaroxaban 5mg + Aspirin Placebo   Rivaroxaban Placebo + Aspirin 100mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 9152   9117   9126   27395 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.3  (7.9)   68.2  (7.9)   68.2  (8.0)   68.2  (7.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2059  22.5%      1972  21.6%      1989  21.8%      6020  22.0% 
Male      7093  77.5%      7145  78.4%      7137  78.2%      21375  78.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Chinese      388   4.2%      381   4.2%      376   4.1%      1145   4.2% 
Hispanic      1769  19.3%      1751  19.2%      1758  19.3%      5278  19.3% 
White/Caucasian      5673  62.0%      5672  62.2%      5682  62.3%      17027  62.2% 
South Asian      107   1.2%      102   1.1%      106   1.2%      315   1.1% 
Other Asian      956  10.4%      938  10.3%      915  10.0%      2809  10.3% 
Black/African American      76   0.8%      94   1.0%      92   1.0%      262   1.0% 
Other      183   2.0%      179   2.0%      197   2.2%      559   2.0% 


  Outcome Measures

1.  Primary:   The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death   [ Time Frame: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]

2.  Primary:   The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria   [ Time Frame: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]

3.  Secondary:   The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death   [ Time Frame: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]

4.  Secondary:   The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death   [ Time Frame: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]

5.  Secondary:   All-cause Mortality   [ Time Frame: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Bayer
phone: (+) 1-888-8422937
e-mail: clinical-trials-contact@bayer.com


Publications of Results:


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01776424     History of Changes
Other Study ID Numbers: 15786
2012-004180-43 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: July 16, 2018
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018