Trials / Completed
CompletedNCT01776424
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
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).
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 27,395 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); * To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban (Xarelto, BAY59-7939) | Tablet, 2.5 mg, twice daily, oral |
| DRUG | Rivaroxaban (Xarelto, BAY59-7939) | Tablet, 5 mg, twice daily, oral |
| DRUG | Aspirin | Tablet, 100 mg, once daily, oral |
| DRUG | Aspirin placebo | Aspirin matching placebo, once daily, oral |
| DRUG | Rivaroxaban placebo | Rivaroxaban matching placebo, twice daily, oral |
| DRUG | Pantoprazole | Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole |
| DRUG | Pantoprazole placebo | Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo |
Timeline
- Start date
- 2013-02-28
- Primary completion
- 2017-07-21
- Completion
- 2021-06-15
- First posted
- 2013-01-28
- Last updated
- 2022-11-28
- Results posted
- 2018-10-05
Locations
565 sites across 33 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01776424. Inclusion in this directory is not an endorsement.