Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

NCT01431495 | Completed Phase 4 DMC

• 1 other identifier: CAPP-study
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Coronary Disease

Keywords

platelet agregation; clopidogrel; major adverse cardiac events (MACE)

Outcome Measures

Primary Outcomes (1)

• - 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

Study Arms (2)

plavix

ACTIVE COMPARATOR

patient treated by the princeps

Drug: Plavix

Pidogrel

ACTIVE COMPARATOR

patient treated by Pidogrel

Drug: Pidogrel

Interventions

Pidogrel DRUG

Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.

Pidogrel

Plavix DRUG

Plavix(R) 75 mg/day for period ranging from 1 to 6 months.

plavix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

cardiology department, hospital La RABTA

Tunis, Tunis BAB Souika, 1007, Tunisia

Location

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rachid MECHMECHE, MD

  hospital La RABTA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 9, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 9, 2011

Record last verified: 2011-09

Locations

TU (1)