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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431495
|cardiology department, hospital La RABTA|
|Tunis, Tunis BAB SOUIKA, Tunisia, 1007|
|Study Chair:||Rachid MECHMECHE, MD||hospital La RABTA|