Status:
COMPLETED
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Bayer
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myo...
Detailed Description
This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to e...
Eligibility Criteria
Inclusion
- Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
- Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature
Exclusion
- Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain)
- Need for continued anticoagulant therapy
- Significantly impaired renal (kidney) or hepatic (liver) function
- Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
3490 Patients enrolled
Trial Details
Trial ID
NCT00402597
Start Date
November 1 2006
End Date
October 1 2008
Last Update
October 4 2012
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