Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study (GeCCO)
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ClinicalTrials.gov Identifier: NCT00995514 |
Recruitment Status :
Terminated
(Administrative reasons)
First Posted : October 15, 2009
Last Update Posted : May 30, 2012
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Condition or disease |
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Cardiovascular Disease |

Study Type : | Observational |
Actual Enrollment : | 4471 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Group/Cohort |
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Clopidogrel
Patients receiving clopidogrel 75 mg/day as prescribed by their physician, and are extensive metabolizers by CYP2C19 genotype
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Prasugrel
Patients receiving prasugrel 5 or 10 mg/day as prescribed by their physician
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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"

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): NCT00995514
United States, New Jersey | |
Medco Health Solutions, Inc | |
Franklin Lakes, New Jersey, United States, 07417 |
Principal Investigator: | Eric J Stanek, Pharm.D. | Medco Health Solutions, Inc. |
Publications:
Responsible Party: | Eric Stanek, Vice President, Research, Medco Health Solutions, Inc. |
ClinicalTrials.gov Identifier: | NCT00995514 |
Other Study ID Numbers: |
GeCCO1 |
First Posted: | October 15, 2009 Key Record Dates |
Last Update Posted: | May 30, 2012 |
Last Verified: | May 2012 |
acute coronary syndrome cardiovascular death non-fatal MI non-fatal stroke genetic testing CYP2C19 |
clopidogrel prasugrel antiplatelet therapy genotyping bleeding |
Cardiovascular Diseases |