Coronary Disease Clinical Trial
Official title:
Clinical Assessment of Pidogrel® Versus Plavix®
This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in
patients with coronary disease:
- Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600
mg loading dose or after the last maintenance dose (75 mg).
- Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events
(MACE).
- Safety Criteria: severe bleeding (GUSTO scale).
after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet
activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the
last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will
determine: - The PRU:-P2Y12 Reaction Units-
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant
patient with PRU> 235 or %inhibition <15%.
Monitoring of patients included in the study will take place over a period of 12 months,
MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary
angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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