Genetics Informatics Trial (GIFT) of Warfarin to Prevent Deep Venous Thrombosis (DVT)

NCT01006733 Phase 3 COMPLETED

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.

Details

Lead sponsor	Washington University School of Medicine
Phase	Phase 3
Status	COMPLETED
Enrolment	1598
Start date	2011-03
Completion	2016-11

Conditions

• Thromboembolism

Interventions

• Pharmacogenetic
• Target INR 1.8

Primary outcomes

• For Aim 1: The composite outcome of: non-fatal venous thromboembolism (VTE), non-fatal major hemorrhage, INR>=4.0, and death. — 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. — 30-days for death; 60 days for VTE

Countries

United States