The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death, stroke, myocardial infarction) after a percutaneous coronary intervention.
Official Title
CURRENT/OASIS 7: Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Conditions
Acute Coronary DiseaseAngina Unstable
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Dose Comparison, Factorial Assignment, Efficacy Study
Further Details
- Primary Outcome Measures: At Day 30, first occurrence of cardiovascular death, myocardial infarction and stroke; second co-primary outcome: first occurrence of cardiovascular death, stroke, myocardial infarction and recurrent ischemia
- Secondary Outcome Measures: At Day 30, rate of major bleeding
Study Start
June 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or aged > 60 years and documented previous coronary artery disease or cardiac enzymes elevated
Exclusion Criteria:
- Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period
- Administration of clopidogrel > 300 mg prior to randomization
- Contraindication to clopidogrel or aspirin
- Active bleeding or significant risk of bleeding
Total Enrolment
14000
Contact Details
- Macquarie Park, Australia; Recruiting
- Cove, New South Wales, Australia; Recruiting
- GV-Contact-us@sanofi-aventis.com
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