Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Les Laboratoires des Médicaments Stériles
• Treatments: Clopidogrel

Criteria

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