Clinical trial NCT01431495: Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
Official title: Clinical Assessment of Pidogrel® Versus Plavix®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Keywords: platelet agregation
clopidogrel
major adverse cardiac events (MACE)
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2011-09-09
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: - 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)
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: cardiology department, hospital La RABTA
state: Tunis BAB SOUIKA
Study officials:
affiliation: hospital La RABTA
name: Rachid MECHMECHE, MD
role: STUDY_CHAIR
References: