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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Unstable Angina

In brief

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.

Key facts

Study ID

NCT00809965

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

15526

Starts

2008-11-01

Expected to finish

2011-09-01

Last updated by the study team

2014-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Geneva, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Burbank, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Hills, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Rome, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Merrillville, Indiana, United States
• Study site — Munster, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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