cardiology department, hospital La RABTA
Tunis, Tunis BAB Souika, 1007, Tunisia
NCT Number: NCT01431495
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Tunis, Tunis BAB Souika, 1007, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
Time frame: 06 months
Les Laboratoires des Médicaments Stériles
Industry
Clinical Assessment of Pidogrel® Versus Plavix®
Acronym: (CAPP)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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