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

Bayer

Status and phase: Completed; Phase 3

Conditions: Prevention & Control

Treatments: Drug: Aspirin; Drug: Aspirin placebo; Drug: Rivaroxaban placebo; Drug: Pantoprazole placebo; Drug: Pantoprazole; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01776424

2012-004180-43 (EudraCT Number)

15786

Details and patient eligibility

About

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.

Enrollment: 27,395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27,395 participants in 3 patient groups

Rivaroxaban 2.5mg + Aspirin 100mg

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Pantoprazole placebo

Drug: Pantoprazole

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 5mg + Aspirin Placebo

Experimental group

Description:

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.

Treatment:

Drug: Aspirin placebo

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Pantoprazole placebo

Drug: Pantoprazole

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban Placebo + Aspirin 100mg

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Pantoprazole placebo

Drug: Pantoprazole

Drug: Rivaroxaban placebo