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

E. J. Do, P. Lenzini, C. S. Eby, A. R. Bass, G. A. McMillin, S. M. Stevens, S. C. Woller, R. C. Pendleton, J. L. Anderson, P. Proctor, R. M. Nunley, V. Davila-Roman, B. F. Gage

Research output: Contribution to journalArticle

58 Scopus citations

Abstract

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, INR4, and death.

Original languageEnglish
Pages (from-to)417-424
Number of pages8
JournalPharmacogenomics Journal
Volume12
Issue number5
DOIs
StatePublished - Oct 1 2012

Keywords

  • dosing algorithm
  • pharmacogenetics
  • randomized controlled trial
  • warfarin

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    Do, E. J., Lenzini, P., Eby, C. S., Bass, A. R., McMillin, G. A., Stevens, S. M., Woller, S. C., Pendleton, R. C., Anderson, J. L., Proctor, P., Nunley, R. M., Davila-Roman, V., & Gage, B. F. (2012). Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design. Pharmacogenomics Journal, 12(5), 417-424. https://doi.org/10.1038/tpj.2011.18