Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

Phase 4

Completed

• Conditions: Coronary Disease
• Interventions: Drug: Plavix; Drug: Pidogrel

• Registration Number: NCT01431495
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Study First Submitted: 2011-08-25
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-08
• Last Update Submitted: 2011-09-08
• Study First Posted: 2011-09-09
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plavix	Plavix	patient treated by the princeps
Pidogrel	Pidogrel	patient treated by Pidogrel

Primary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (1)

cardiology department, hospital La RABTA; 🇹🇳 Tunis, Tunis BAB SOUIKA, Tunisia