Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Assessment of Pidogrel® Versus Plavix®|
- - study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE) [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: plavix
patient treated by the princeps
Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
Active Comparator: Pidogrel
patient treated by Pidogrel
Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
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.
|cardiology department, hospital La RABTA|
|Tunis, Tunis BAB SOUIKA, Tunisia, 1007|
|Study Chair:||Rachid MECHMECHE, MD||hospital La RABTA|