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Completed

NCT Number: NCT00992420

Genotype Information and Functional Testing Study

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Genomic Medicine

La Jolla, California, 92037, United States

About this study

AS DESCRIBED BY THE PI: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. residual platelet reactivity

    Time frame: 6 months

    Outcome 1 is residual platelet reactivity the measurement

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Collaborators

  • Accumetrics, Inc.
  • Bristol-Myers Squibb
  • Sanofi

Registry information

Official study title

GIFT: Genotype Information and Functional Testing Study

Acronym: GIFT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2009
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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