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Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study (GeCCO)

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. Identifier: NCT00995514
Recruitment Status : Terminated (Administrative reasons)
First Posted : October 15, 2009
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
Eric Stanek, Medco Health Solutions, Inc.

Brief Summary:
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 or disease
Cardiovascular Disease

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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

Resource links provided by the National Library of Medicine

Patients receiving clopidogrel 75 mg/day as prescribed by their physician, and are extensive metabolizers by CYP2C19 genotype
Patients receiving prasugrel 5 or 10 mg/day as prescribed by their physician

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Total health care resource utilization and cost-effectiveness [ Time Frame: 6 and 12 months ]
  3. Health-related quality of life and activity/work productivity [ Time Frame: 6 and 12 months ]
  4. Incidence of hospitalization for site- and cause-specific bleeding [ Time Frame: 6 and 12 months ]
  5. Incidence of new or recurrent cancer [ Time Frame: 6 and 12 months ]
  6. To compare the incidence of the composite primary endpoint between the two study groups. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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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
Study Population
Adults between the ages of 18 and 75 with newly initiated clopidogrel (Plavix) or prasugrel (Effient) therapy.

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"

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 identifier (NCT number): NCT00995514

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United States, New Jersey
Medco Health Solutions, Inc
Franklin Lakes, New Jersey, United States, 07417
Sponsors and Collaborators
Medco Health Solutions, Inc.
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Principal Investigator: Eric J Stanek, Pharm.D. Medco Health Solutions, Inc.
Additional Information:

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Responsible Party: Eric Stanek, Vice President, Research, Medco Health Solutions, Inc. 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
Keywords provided by Eric Stanek, Medco Health Solutions, Inc.:
acute coronary syndrome
cardiovascular death
non-fatal MI
non-fatal stroke
genetic testing
antiplatelet therapy
Additional relevant MeSH terms:
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Cardiovascular Diseases