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Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): rationale and study design

2011; Springer Nature; Volume: 12; Issue: 5 Linguagem: Inglês

10.1038/tpj.2011.18

1473-1150

Robert J Engeszer, Petra A. Lenzini, Charles S. Eby, Anne R. Bass, Gwendolyn A. McMillin, Scott M. Stevens, Scott C. Woller, Robert C. Pendleton, Jeffrey L. Anderson, Paul Proctor, Ryan M. Nunley, Víctor G. Dávila‐Román, Brian F. Gage,

Antiplatelet Therapy and Cardiovascular Diseases

The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR⩾4, and death.