Pharmacogenetic Dosing of Warfarin

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.

Conditions

• Stroke
• Venous Thrombosis
• Atrial Fibrillation
• Atrial Flutter

Interventions

BEHAVIORAL

Standard of care dosing for warfarin

GENETIC

Genotype-guided dosingTaiwan algorithm for warfarin

GENETIC

Genotype-guided dosing IWPC algorithm for warfarin

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• Kaohsiung Medical University

  collaborator OTHER

• Academia Sinica, Taiwan

  lead OTHER

Principal Investigators

• Ming Ta Michael Lee, PhD · Institute of Biomedical Sciences, Academia Sinica

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Taiwan

Study Locations