drugset / Trial / NCT01431495

Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

NCT01431495

Phase 4 Completed 219 enrolled Les Laboratoires des Médicaments Stériles
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2010-04
Primary completion
2011-06
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg
Comparator clopidogrel bisulfate Unknown 75 mg