Status:
COMPLETED
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
Lead Sponsor:
Les Laboratoires des Médicaments Stériles
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 afte...
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01431495
Start Date
April 1 2010
End Date
July 1 2011
Last Update
September 9 2011
Active Locations (1)
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1
cardiology department, hospital La RABTA
Tunis, Tunis BAB Souika, Tunisia, 1007