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Genotype Information and Functional Testing Study (GIFT)

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Accumetrics, Inc.
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT00992420
First received: October 5, 2009
Last updated: January 13, 2011
Last verified: August 2010
  Purpose

This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GIFT: Genotype Information and Functional Testing Study

Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • residual platelet reactivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 2000
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
GRAVITAS Study Arm A
"Tailored" clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months
GRAVITAS Study Arm B
"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months.
GRAVITAS Study Arm C
Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination.

Criteria

Inclusion Criteria:

  • Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination

Exclusion Criteria:

  • See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)
  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: NCT00992420

Locations
United States, California
Scripps Genomic Medicine
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Health
Bristol-Myers Squibb
Sanofi
Accumetrics, Inc.
Investigators
Principal Investigator: Matthew J Price, MD Scripps Clinic, La Jolla, CA
  More Information

No publications provided by Scripps Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Price, M.D./Principal Investigator, Scripps Health/Scripps Genomic Institute
ClinicalTrials.gov Identifier: NCT00992420     History of Changes
Other Study ID Numbers: P95082S
Study First Received: October 5, 2009
Last Updated: January 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Health:
thienopyridine
platelets
CYP2C19
clopidogrel
platelet function tests
platelet
genes
cytochrome P450
single nucleotide polymorphisms
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014