NCT03479684

Genotype-guided Versus Standard for Warfarin Dosing

Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。

Detailed description

Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.

Conditions

• Atrial Fibrillation
• Valvular Heart Disease

Interventions

Type	Name	Description
OTHER	Gene-directed dosage of warfarin	the first day given model prediction dose \* 1.5 times（\<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day
OTHER	standard dosage of warfarin	the first day given 4.5mg; adjusted dose based on INR from the second day

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-03-27
• Last updated: 2022-04-29

Locations

1 site across 1 country: China