An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Phase 3
Completed
- Conditions
- Health Condition 1: null- Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15527
Inclusion Criteria
Inclusion Criteria:
Ages Eligible for Study: 18 Years and older. There is no upper age limit for this study.
Genders Eligible for Study: Both
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
Exclusion Criteria:
Patient below 18 years of age.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint is the composite of CV death, MI, or stroke.Timepoint: 6-day screening phase,<br>- treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). <br>- enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2
- Secondary Outcome Measures
Name Time Method