Clinical Assessment of Pidogrel� Versus Plavix� (CAPP)
Information source: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Disease
Intervention: Pidogrel (Drug); Plavix (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Les Laboratoires des Médicaments Stériles Official(s) and/or principal investigator(s): Rachid MECHMECHE, MD, Study Chair, Affiliation: hospital La RABTA
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).
Clinical Details
Official title: Clinical Assessment of Pidogrel® Versus Plavix®
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: - 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)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
cardiology department, hospital La RABTA, Tunis, Tunis BAB SOUIKA 1007, Tunisia
Additional Information
Starting date: April 2010
Last updated: September 8, 2011
|