Clinical Assessment of Pidogrel® Versus Plavix® (CAPP) ((CAPP))

Clinical Assessment of Pidogrel® Versus Plavix®

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).

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Drug: Plavix; Drug: Pidogrel

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis BAB SOUIKA
    • Tunis, Tunis BAB SOUIKA, Tunisia, 1007
      • cardiology department, hospital La RABTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: plavix; patient treated by the princeps	Drug: Plavix; Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
Active Comparator: Pidogrel; patient treated by Pidogrel	Drug: Pidogrel; Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- 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)	06 months

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Investigators: Study Chair: Rachid MECHMECHE, MD, Hospital La Rabta

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): September 9, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: clopidogrel; platelet agregation; major adverse cardiac events (MACE)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: CAPP-study