Coronary Disease
Conditions
Keywords
platelet agregation, clopidogrel, major adverse cardiac events (MACE)
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.
Interventions
DRUGPidogrel
Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
DRUGPlavix
Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
Sponsors
Les Laboratoires des Médicaments Stériles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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 |
Countries
Tunisia
Outcome results
None listed