Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

Les Laboratoires des Médicaments Stériles

Status and phase

Completed

Phase 4

Conditions

Coronary Disease

Treatments

Drug: Pidogrel

Drug: Plavix

Study type

Interventional

Funder types

Industry

Identifiers

NCT01431495

CAPP-study

Details and patient eligibility

About

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).

Full 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.

Enrollment

219 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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