Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study (GeCCO)
This study has been terminated.
(Administrative reasons)
Sponsor:
Medco Health Solutions, Inc.
Information provided by (Responsible Party):
Eric Stanek, Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT00995514
First received: October 14, 2009
Last updated: May 29, 2012
Last verified: May 2012
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Purpose
The primary objective of this trial is to demonstrate the non-inferiority of clopidogrel compared to prasugrel over 6 months in cardiovascular disease patients when the clopidogrel cohort is limited to the estimated 70% of the population that are CYP2C19 extensive metabolizers. This protocol will examine the comparative effectiveness of these two strategies.
| Condition |
|---|
|
Cardiovascular Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study |
Resource links provided by NLM:
Further study details as provided by Medco Health Solutions, Inc.:
Primary Outcome Measures:
- Non-inferiority of clopidogrel therapy in CYP2C19 extensive metabolizers with cardiovascular disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]To assess the non-inferiority of clopidogrel therapy in patients with cardiovascular disease who are CYP2C19 extensive metabolizers (identified by genetic testing) compared to prasugrel therapy (non-genotyped) on the composite primary end point of cardiovascular death, hospitalization for acute coronary syndrome (nonfatal MI or unstable angina), nonfatal stroke or coronary revascularization
Secondary Outcome Measures:
- Incidence between the two study groups of all individual components of the primary end point. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Number of hospitalizations and ER visits for other cardiovascular events not included in the primary composite endpoint.
- the primary (composite) endpoint and the individual components of the primary end point in subjects who are CYP2C19 intermediate metabolizers (IM) with clopidogrel EM and prasugrel populations
- the primary (composite) endpoint and the individual components of the primary end point in the population of CYP2C19 intermediate and extensive metabolizers with the prasugrel population.
- Total health care resource utilization and cost-effectiveness [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Health-related quality of life and activity/work productivity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Incidence of hospitalization for site- and cause-specific bleeding [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
- Incidence of new or recurrent cancer [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
- To compare the incidence of the composite primary endpoint between the two study groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Saliva
| Enrollment: | 4471 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Clopidogrel
Patients receiving clopidogrel 75 mg/day as prescribed by their physician, and are extensive metabolizers by CYP2C19 genotype
|
|
Prasugrel
Patients receiving prasugrel 5 or 10 mg/day as prescribed by their physician
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults between the ages of 18 and 75 with newly initiated clopidogrel (Plavix) or prasugrel (Effient) therapy.
Criteria
Inclusion Criteria:
- Men and women between 18 years and 75 years of age
- Recent prescription for clopidogrel or prasugrel.
- Participant is willing and able to provide informed consent.
Exclusion Criteria:
- Previous use of any thienopyridine within 4 months of initiating new clopidogrel or prasugrel therapy.
- Participant refusal to participate in the study.
- Anticipated discontinuation of clopidogrel or prasugrel within the 6 month study follow-up period
- Participants that have previously stated "do not contact"
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995514
Locations
| United States, New Jersey | |
| Medco Health Solutions, Inc | |
| Franklin Lakes, New Jersey, United States, 07417 | |
Sponsors and Collaborators
Medco Health Solutions, Inc.
Investigators
| Principal Investigator: | Eric J Stanek, Pharm.D. | Medco Health Solutions, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Eric Stanek, Vice President, Research, Medco Health Solutions, Inc. |
| ClinicalTrials.gov Identifier: | NCT00995514 History of Changes |
| Other Study ID Numbers: | GeCCO1 |
| Study First Received: | October 14, 2009 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medco Health Solutions, Inc.:
|
acute coronary syndrome cardiovascular death non-fatal MI non-fatal stroke genetic testing CYP2C19 |
clopidogrel prasugrel antiplatelet therapy genotyping bleeding |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Clopidogrel Prasugrel 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 May 16, 2013