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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 Eric Stanek, Medco Health Solutions, Inc.:
Primary Outcome Measures:
- Non-inferiority of clopidogrel therapy in CYP2C19 extensive metabolizers with cardiovascular disease [ Time Frame: 6 months ]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 ]
- 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 ]
- Health-related quality of life and activity/work productivity [ Time Frame: 6 and 12 months ]
- Incidence of hospitalization for site- and cause-specific bleeding [ Time Frame: 6 and 12 months ]
- Incidence of new or recurrent cancer [ Time Frame: 6 and 12 months ]
- To compare the incidence of the composite primary endpoint between the two study groups. [ Time Frame: 12 months ]
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995514
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 |
Keywords provided by Eric Stanek, 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 Ticlopidine Prasugrel Hydrochloride 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 September 21, 2017