Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT

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.

Conditions

• Thromboembolism

Interventions

GENETIC

Pharmacogenetic

The pharmacogenetic arm estimates therapeutic warfarin dose using cytochrome P 450 2C9 (CYP2C9), vitamin K epoxide reductase complex subunit 1 (VKORC1), and cytochrome P 450 4F2 (CYP4F2) genotype and clinical information. The clinical arm estimates warfarin dose from clinical information alone.

DRUG

Target INR 1.8

We will randomize patients to a target International Normalized Ratio (INR) of 2.5 or 1.8.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Hospital for Special Surgery, New York

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Brian F Gage, MD, MSc · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2016-10-31

Completion

2016-11-30

Countries

• United States

Study Locations