search
Back to results

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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Pidogrel
Plavix
Sponsored by
Les Laboratoires des Médicaments Stériles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring platelet agregation, clopidogrel, major adverse cardiac events (MACE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • cardiology department, hospital La RABTA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

plavix

Pidogrel

Arm Description

patient treated by the princeps

patient treated by Pidogrel

Outcomes

Primary Outcome Measures

- 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)

Secondary Outcome Measures

Full Information

First Posted
August 25, 2011
Last Updated
September 8, 2011
Sponsor
Les Laboratoires des Médicaments Stériles
search

1. Study Identification

Unique Protocol Identification Number
NCT01431495
Brief Title
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
Acronym
(CAPP)
Official Title
Clinical Assessment of Pidogrel® Versus Plavix®
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
platelet agregation, clopidogrel, major adverse cardiac events (MACE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plavix
Arm Type
Active Comparator
Arm Description
patient treated by the princeps
Arm Title
Pidogrel
Arm Type
Active Comparator
Arm Description
patient treated by Pidogrel
Intervention Type
Drug
Intervention Name(s)
Pidogrel
Intervention Description
Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
Intervention Type
Drug
Intervention Name(s)
Plavix
Intervention Description
Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
Primary Outcome Measure Information:
Title
- 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)
Time Frame
06 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachid MECHMECHE, MD
Organizational Affiliation
hospital La RABTA
Official's Role
Study Chair
Facility Information:
Facility Name
cardiology department, hospital La RABTA
City
Tunis
State/Province
Tunis BAB SOUIKA
ZIP/Postal Code
1007
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

We'll reach out to this number within 24 hrs