An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Bayer
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation

• Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding

• Need for continued anticoagulant therapy

• Significant renal impairment or known significant liver disease