Woman and Man
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Extract
The primary objective of this study is to test the hypothesis that prasugrel and aspirin is superior to clopidogrel and aspirin in the treatment of medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. Superiority will be assessed by the reduction in risk of the composite endpoint of first occurrence of cardiovascular (CV) death, myocardial infarction (MI), or stroke throughout the study. The primary analysis will be conducted in a hierarchical manner, with evaluation of the primary endpoint performed first in medically managed UA/NSTEMI subjects < age 75 years. Conditional on successfully establishing superiority in the primary analysis, the same composite endpoint will be evaluated in the entire population.
Inclusion criteria
- Treatment of Acute Coronary Syndrome in medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event