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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

Page last updated: August 23, 2015

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