A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome
- Conditions
- Acute coronary syndromecoronary artery disease10011082
- Registration Number
- NL-OMON33485
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1) An acute coronary syndrome within 7 days characterized by:
a) Symptoms of myocardial ischemia at rest lasting at least 10 minutes
And either
b) Elevation in cardiac biomarkers above the local upper limit of normal
Or
c) Dynamic ST-segment deviation (depression or elevation >= 0.1 mV (1.0 mm))
2) Completion of parenteral anticoagulation therapy for the index ACS event.
3) Clinically stable, receiving standard of care for ACS, including single or dual antiplatelet therapy, at the discretion of the treating physician.
4) Two or more of the following risk factors
a) Age >= 65 year
b) Diabetes mellitus
c) Prior myocardial infarction (other than the qualifying event) within 5 years
d) Ischemic cerebrovascular disease
e) Peripheral vascular disease (symptoms of claudication and/or peripheral revascularization, and/or ankle-brachial index (ABI) < 0.9)
f) Heart failure or left ventricular ejection fraction < 40% associated with the index ACS event
g) Impaired renal function (calculated CrCl < 60 mL/min)
h) No revascularization for index ACS event.
1. Persistent severe hypertension (SBP * 180 mmHg of DB * 110 mmHg)
2. Calculated CrCl < 20 mL/min or on dialysis for end-stage renal disease
3. Active bleeding or high risk for major bleeding
4. Known coagulopathy
5. Acute pericarditis
6. Recent (<7 days) ischemic stroke
7. NYHA Class IV heart failure at time of randomization
8. Any history of intracranial bleeding
9. Active and/or significant, known hepatobiliary disease
10. Required ongoing treatment with a parenteral or chronic oral anticoagulant (eg, mechanical valve, recent DVT or pulmonary embolism, known left ventricular thrombus)
11. Required ongoing treatment with a strong inhibitor of CYP3A4, macrolide antibiotics, protease inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy outcome: Time to first occurrence of cardiovascular death,<br /><br>myocardial infarction, or ischemic stroke.<br /><br>Primary safety outcome: Time to first occurrence of TIMI major bleeding.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy outcomes: Time to first occurence:<br /><br>• Cardiovascular death, myocardial infarction, unstable angina or ischemic<br /><br>stroke.<br /><br>• Cardiovascular death, fatal bleeding, myocardial infarction or stroke<br /><br>(ischemic or hemorrhagic).<br /><br>• Death (all-cause), myocardial infarction or stroke (ischemic or hemorrhagic).<br /><br><br /><br>Secondary safety outcome: Time to first occurrence of ISTH major bleeding.</p><br>