drugset / Trial / NCT02065388

Pharmacogenetic Dosing of Warfarin

NCT02065388

RandomizedParallel-groupTriple-blindTreatment

Summary

Purpose: Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing algorithm which can predict patients required warfarin dose, thus could prevent warfarin induced warfarin adverse events. Methods: The investigators recruited patients with indications for warfarin, the genotypes of VKORC1 and CYP2C9 were determined by the hospitals and verified by National Center for Genome Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard of care. The investigators aimed to determine whether using genetic dosing algorithm can lead to more stable dose and safer use of the drug.

Timeline

Start
2009-09
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Warfarin Small molecule 5 mg Oral