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Identification of Clopidogrel CYP2C19 Metabolizer and Thienopyridine Treatment After an Acute Coronary Syndrome (GAMMA)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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.
| 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 ]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 ]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.
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Show Detailed Description
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01390974
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
| 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 ) |
| Study First Received: | July 7, 2011 |
| Last Updated: | February 7, 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 |
ClinicalTrials.gov processed this record on July 19, 2017