Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Hospital for Special Surgery, New York; Intermountain Health Care, Inc.; National Heart, Lung, and Blood Institute (NHLBI); Rush University Medical Center; University of Texas Southwestern Medical Center; University of Utah
• Treatments: Warfarin

Criteria

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