Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): rationale and study design. Academic Article uri icon

Overview

MeSH

  • Cytochrome P-450 CYP2C9
  • Dose-Response Relationship, Drug
  • Genotype
  • Humans
  • Postoperative Period
  • Vitamin K Epoxide Reductases

MeSH Major

  • Aryl Hydrocarbon Hydroxylases
  • Mixed Function Oxygenases
  • Venous Thrombosis
  • Warfarin

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, INR ≥ 4, and death.

publication date

  • October 2012

has subject area

  • Aryl Hydrocarbon Hydroxylases
  • Cytochrome P-450 CYP2C9
  • Dose-Response Relationship, Drug
  • Genotype
  • Humans
  • Mixed Function Oxygenases
  • Postoperative Period
  • Venous Thrombosis
  • Vitamin K Epoxide Reductases
  • Warfarin

Research

keywords

  • Journal Article
  • Randomized Controlled Trial

Identity

Language

  • eng

PubMed Central ID

  • PMC3175019

Digital Object Identifier (DOI)

  • 10.1038/tpj.2011.18

PubMed ID

  • 21606949

Additional Document Info

start page

  • 417

end page

  • 424

volume

  • 12

number

  • 5