Completed

COMPASSA 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).

What is being tested

Rivaroxaban (Xarelto, BAY59-7939)

+ Aspirin

+ Pantoprazole

Drug

Who is being recruted

Angina Pectoris+24

+ Arterial Occlusive Diseases

+ Arteriosclerosis

Over 18 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3

Interventional

Study Start: February 2013

See protocol details

Summary

Principal SponsorBayer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 28, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleA 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).

NCT01776424

Principal SponsorBayer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

27395 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Angina PectorisArterial Occlusive DiseasesArteriosclerosisBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersChest PainCoronary Artery DiseaseCoronary DiseaseHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisNervous System DiseasesNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesPeripheral Vascular DiseasesMyocardial IschemiaStrokeAtherosclerosisPeripheral Arterial Disease

Criteria

Inclusion Criteria: \- Meet criteria for CAD and/or PAD Subjects with CAD must also meet at least one of the following criteria: * Age ≥65, or * Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors Exclusion Criteria: * Stroke within 1 month or any history of hemorrhagic or lacunar stroke * Severe heart failure with known ejection fraction \<30% or New York Heart Association (NYHA) class III or IV symptoms * Estimated glomerular filtration rate (eGFR)\<15 mL/min * Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

Group II

Experimental

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 additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

Group III

Active Comparator

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. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers