Status:
COMPLETED
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Bayer
Conditions:
Acute Coronary Syndrome
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
15526 Patients enrolled
Trial Details
Trial ID
NCT00809965
Start Date
November 1 2008
End Date
September 1 2011
Last Update
September 17 2014
Active Locations (556)
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1
Birmingham, Alabama, United States
2
Geneva, Alabama, United States
3
Mobile, Alabama, United States
4
Anaheim, California, United States