Identification of Clopidogrel CYP2C19 Metabolizer and Thienopyridine Treatment After an Acute Coronary Syndrome (GAMMA)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01390974
First received: July 7, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows to select adequately one of the 2 antiplatelet treatments approved in the same indication (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar levels of platelet inhibition with the 2 different thienopyridines suggesting optimal risk/benefit ratio in most patients with individualized therapy.


Condition Phase
Acute Coronary Syndrome
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bedside Genetic Approach to Identify Clopidogrel CYP2C19 Metabolizer and Optimize Maintenance Thienopyridine Treatment After an Acute Coronary Syndrome: The GAMMA Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • proportion of patients who are within the optimal prespecified window of P2Y12 inhibition [ Time Frame: At one month ] [ Designated as safety issue: No ]
    the proportion of rapid metabolizers treated with a 75mg clopidogrel MD within the optimal range of P2Y12 inhibition at 30 days, (defined as a threshold of 220 AU·min up to 350 AU·min of ADP-induced platelet aggregation measured by the Multiple Electrode platelet Aggregometry - Multiplate analyzer, Dynabyte, Munich, Germany or a % inhibition between 30% up to 80% using the VerifyNowTMP2Y12 platform),


Secondary Outcome Measures:
  • proportion of patients who are within the optimal prespecified window of P2Y12 inhibition [ Time Frame: at 45 days ] [ Designated as safety issue: No ]
    the proportion of rapid metabolizers treated with a 75mg clopidogrel MD within the optimal range of P2Y12 inhibition at 30 days, (defined as a threshold of 220 AU·min up to 350 AU·min of ADP-induced platelet aggregation measured by the Multiple Electrode platelet Aggregometry - Multiplate analyzer, Dynabyte, Munich, Germany or a % inhibition between 30% up to 80% using the VerifyNowTMP2Y12 platform),


Enrollment: 270
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated for ACS
ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.

Criteria

Inclusion Criteria:

- ACS patients who underwent Percutaneous coronary intervention

Exclusion Criteria:

  • Anemia <10g/dL
  • Indication for VKA
  • Recent bleeding or planned surgery
  • Thrombopenia <80 000/µl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390974

Locations
France
ACTION-Institut de Cardiologie-Groupe Hospitalier Pitié-Salpêtrière (APHP) Université Pierre et Marie Curie (UPMC)
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Jean Philippe COLLET, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01390974     History of Changes
Other Study ID Numbers: P101203, 2011-A00543-38
Study First Received: July 7, 2011
Last Updated: February 7, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ACS
PCI
thienopyridines
prasugrel therapy
clopidogrel therapy

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014