NCT01431495

Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

Clinical Assessment of Pidogrel® Versus Plavix®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Les Laboratoires des Médicaments Stériles · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DRUG	Pidogrel	Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
DRUG	Plavix	Plavix(R) 75 mg/day for period ranging from 1 to 6 months.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2011-09-09
• Last updated: 2011-09-09

Locations

1 site across 1 country: Tunisia