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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431495
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles

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).

Condition or disease Intervention/treatment Phase
Coronary Disease Drug: Pidogrel Drug: Plavix Phase 4

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  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Pidogrel® Versus Plavix®
Study Start Date : April 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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) [ Time Frame: 06 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431495

cardiology department, hospital La RABTA
Tunis, Tunis BAB SOUIKA, Tunisia, 1007
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
Study Chair: Rachid MECHMECHE, MD hospital La RABTA

Responsible Party: Les Laboratoires des Médicaments Stériles Identifier: NCT01431495     History of Changes
Other Study ID Numbers: CAPP-study
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Les Laboratoires des Médicaments Stériles:
platelet agregation
major adverse cardiac events (MACE)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs