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

This study has been terminated.
(Administrative reasons)
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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 July 10, 2014