Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

Coronary Disease Clinical Trial

— (CAPP)  

Official title:

Clinical Assessment of Pidogrel® Versus Plavix®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431495
• Other study ID #: CAPP-study
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2011
• Last updated: September 8, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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

Locations

Country	Name	City	State
Tunisia	cardiology department, hospital La RABTA	Tunis	Tunis BAB SOUIKA

Sponsors (1)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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	Yes