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

The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Enrollment: 27395
Actual Study Start Date: February 28, 2013
Estimated Study Completion Date: March 31, 2018
Primary Completion Date: July 21, 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Rivaroxaban [2.5mg] + Aspirin
- Experimental: Rivaroxaban [5mg] + Placebo(1)
- Active Comparator: Aspirin + Placebo(2)