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

• Status: Completed
• Trial end date: 2021-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Hamilton Health Sciences Corporation, Population Health Research Institute; Janssen Research & Development, LLC; Population Health Research Institute
• Treatments: Aspirin; Pantoprazole; Rivaroxaban

Criteria

Inclusion Criteria:

-- Coronary or peripheral artery disease

Patients with coronary artery disease must also meet at least one of the following:

• 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:

• Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy

• 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