Identification of Clopidogrel CYP2C19 Metabolizer and Thienopyridine Treatment After an Acute Coronary Syndrome (GAMMA)
|
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. |
| ClinicalTrials.gov Identifier: NCT01390974 |
|
Recruitment Status
:
Completed
First Posted
: July 11, 2011
Last Update Posted
: February 10, 2014
|
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|
| Acute Coronary Syndrome |
Show Detailed Description
| 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 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | November 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Clopidogrel bisulfate
U.S. FDA Resources
| Group/Cohort |
|---|
|
Patients treated for ACS
ACS patients who recently underwent stent PCI, who are stable and eligible for prasugrel or clopidogrel therapy.
|
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),
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
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 |
| 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 |