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Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:
NCT01431495
First received: August 25, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Coronary Disease
Drug: Pidogrel
Drug: Plavix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Pidogrel® Versus Plavix®

Resource links provided by NLM:


Further study details as provided by Les Laboratoires des Médicaments Stériles:

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) [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]

Enrollment: 219
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431495

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

No publications provided

Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT01431495     History of Changes
Other Study ID Numbers: CAPP-study
Study First Received: August 25, 2011
Last Updated: September 8, 2011
Health Authority: Tunisia: Office of Pharmacies and Medicines

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

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

ClinicalTrials.gov processed this record on November 24, 2014