A Phase 2, Placebo-Controlled, Randomized, Double-Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients with a Recent Acute Coronary Syndrome
Phase 2
Withdrawn
- Conditions
- Acute Coronary Syndromnarrowing in the major coronary arteries10011082
- Registration Number
- NL-OMON30198
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
- recent (<= 7 days) Acute Coronary Syndrome
- unknown coronary anatomy or > 50 % stenosis in at least one major coronary artery
- plus 1 or more additional cardiovascular risk characteristics (eg, DM, Htn, PVD, CHF)
Exclusion Criteria
- planned PCI or CABG procedure following randomisation
- persistent severe hypertension
- severe renal dysfunction
- recent stroke (within the last 3 months)
- NYHA class IV
- platelet count <= 100, 000/mm3, hemoglobin < 10 g/dL, hematocrit < 30%
- Need for ongoing treatment with a parenteral or oral anticoagulant
- chronic NSAID or chronic high dose aspirin use (>325 mg/day)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary safety outcome is the composite of major bleeding and clinically<br /><br>significant non-major bleeding occurring through the end of treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary safety outcomes for this trial are 1) all bleeding events,<br /><br>including major bleeding, clinically significant non-major bleeding and minor<br /><br>bleeding occurring through the end of treatment and 2) the composite of<br /><br>all-cause death, non-fatal myocardial infarction, severe recurrent ischemia and<br /><br>non hemorrhagic stroke during the 30 days after discontinuation of therapy.<br /><br>Other safety outcome measures will also be assessed, and will include adverse<br /><br>events and abnormal standard clinical laboratory test results, eg., hemoglobin,<br /><br>platelet count, ALT/AST and creatinine.</p><br>