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

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ClinicalTrials.gov Identifier: NCT01390974
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Phase
Acute Coronary Syndrome Phase 4

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 270 participants
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
Study Start Date : July 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients treated for ACS
ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.


Outcome Measures

Primary Outcome Measures :
  1. proportion of patients who are within the optimal prespecified window of P2Y12 inhibition [ Time Frame: At one month ]
    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 :
  1. proportion of patients who are within the optimal prespecified window of P2Y12 inhibition [ Time Frame: at 45 days ]
    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),


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01390974     History of Changes
Other Study ID Numbers: P101203
2011-A00543-38 ( Other Identifier: IDRCB )
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
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
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors