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Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy. (CURRENT/OASIS7)
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 (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 25086 |
| Start date | 2006-06 |
| Completion | 2009-09 |
Conditions
- Acute Coronary Disease
- Angina Unstable
Interventions
- Clopidogrel
- acetylsalicyclic acid (ASA)
Primary outcomes
- First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison — 30 days
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC). - First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison — 30 days
- First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level — 30 days
- First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup — 30 days
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, Singapore