CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27,395 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +6 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01776424
NCT01776424Phase 3Completed
CompareCT.gov

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).

Bayer·interventional·Posted Jan 28, 2013·Updated Nov 28, 2022

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939), Aspirin, and 4 other interventions for Prevention & Control. Completed, enrolled 27,395 participants across 565 sites in 33 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention & Control
CountriesArgentina, 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, United States
CollaboratorsPopulation Health Research Institute, Janssen Research & Development, LLC

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartFeb 28, 2013
Primary CompletionJul 21, 2017
Study CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.4 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Tablet, 2.5 mg, twice daily, oral

Rivaroxaban (Xarelto, BAY59-7939)drug

Tablet, 5 mg, twice daily, oral

Aspirindrug

Tablet, 100 mg, once daily, oral

Aspirin placebodrug

Aspirin matching placebo, once daily, oral

Rivaroxaban placebodrug

Rivaroxaban matching placebo, twice daily, oral

Pantoprazoledrug

Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole

Pantoprazole placebodrug

Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo