Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Clinical Assessment of Pidogrel® Versus Plavix®

Conditions
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Coronary Disease

Intervention / Treatment
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* Drug: Pidogrel
* Drug: Plavix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, Old (e) over 20 years Patients hospitalized for acute coronary syndrome (Whatever the T and troponin) Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days) Exclusion Criteria: Patients unwilling. Patient participating in another study. Patients with cardiogenic shock Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability Patients scheduled for surgery in less than 6 months. Patients candidates for coronary angioplasty Patients who underwent TAC + / - bare stent fewer than 30 days. Patients who underwent stenting with ATC active there is less than 12 months. ischemic stroke older than 6 weeks. History of hemorrhagic stroke (any time) Patients on warfarin or candidates Patients with a different anti ADP (ticlopidine, prasugrel) Patients with indication for clopidogrel-cons (side effects, bleeding ...) Thrombocytopenia <100000/mm3 anemia (Ht <30%) Thrombocythaemia (Ht> 52%) Patients seeking treatment for an elective forms of Clopidogrel. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plavix<br>patient treated by the princeps | Drug: Plavix<br>* Plavix(R) 75 mg/day for period ranging from 1 to 6 months.<br>|
| Active Comparator: Pidogrel<br>patient treated by Pidogrel | Drug: Pidogrel<br>* Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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) |  | 06 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet agregation, clopidogrel, major adverse cardiac events (MACE)