CompletedPhase 3

Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT

United States1,598 participantsStarted 2011-03

Plain-language summary

Blood clots contribute to the death of at least 100,000 Americans each year. Because many of these deaths occur suddenly where treatment is impossible, the best treatment is prevention. With this grant, researchers in Missouri, New York, Utah, Illinois, and Texas are developing strategies to improve the safety and effectiveness of clot prevention by customizing a popular blood thinner (warfarin) to each person's genetic and clinical profile. They hypothesize that the use of genetics to guide warfarin therapy will reduce the risk of venous thromboembolism (VTE) postoperatively. They further hypothesize that using a target international normalized ratio (INR) of 1.8 is non-inferior to using a target INR of 2.5 in VTE prevention.

Who can participate

Age range65 Years

SexALL

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Inclusion Criteria: * 65 years of age or older * must anticipate taking warfarin for at least 4 weeks for VTE prophylaxis after hip or knee arthroplasty * must be able to give written, informed consent * must have venous access * must not be institutionalized, incarcerated at the time of enrollment (nursing home okay) * must have life expectancy \> 6 months * must have plans to have regular INR monitoring * willing/able to follow-up in 3-7 weeks with a Doppler Ultrasound Exclusion Criteria: * Baseline INR \> 1.35 * knowledge of CYP2C9, VKORC1, or CYP4F2 genotype * knowledge of warfarin dose requirements from prior warfarin therapy * absolute contraindication or allergy to warfarin therapy (e.g. pregnancy) * receiving or planning to receive any anticoagulant besides warfarin (if low molecular weight heparin (LMWH) or subcutaneous heparin is deemed necessary by the clinician after enrollment, such patients will be allowed to remain in the study) * unlikely to be compliant (e.g. due to history of non-compliance, or alcoholism) * known thrombophilia, bleeding disorder, or history of serious bleed in the past 2 years (unless caused by trauma) * personal history of venous thromboembolism

What they're measuring

For Aim 1: The composite outcome of: non-fatal venous thromboembolism (VTE), non-fatal major hemorrhage, INR>=4.0, and death.

Timeframe: 30-days, except that VTE may be detected up to day 60

For Aim 2: The composite outcome of: non-fatal venous thromboembolism (VTE) and death.

Timeframe: 30-days for death; 60 days for VTE

Trial details

NCT IDNCT01006733

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

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