A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000023-15

Femme et Homme

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Extrait

The primary objective of this study is to test the hypothesis that CS-747 plus aspirin is superior to clopidogrel plus aspirin in the treatment of subjects with acute coronary syndrome who are to undergo percutaneous coronary intervention, as measured by a reduction in the composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke at a median follow-up of at least 12 months. CS-747 will be given as an oral loading dose of 60 mg, followed by an oral maintenance dose of 10 mg once daily (QD). Clopidogrel will be given as an oral loading dose of 300 mg, followed by an oral maintenance dose of 75 mg QD. The primary endpoint will be analyzed first in the subjects with unstable angina (UA) and non-ST-segment elevation myocardial infarction (NSTEMI), followed by analysis of the same endpoint in all ACS subjects (UA, NSTEMI and ST-segment elevation myocardial infarction [STEMI]).


Critère d'inclusion

  • Reduction of atherothrombotic events in patients with acute coronary syndromes (ACS) that is patients with ST-segment elevation MI [STEMI], non-ST-segment elevation MI [NSTEMI], or unstable angina [UA], who are to undergo percutaneous coronary intervention (PCI)