Clinical trial NCT03479684: Genotype-guided Versus Standard for Warfarin Dosing
Official title: Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Valvular Heart Disease
Keywords: warfarin
gene
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2018-03-27
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. Patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent.

Exclusion Criteria:

* Patients will be excluded from the trial if aged \<18 years old or \> 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their CYP2C9 or VKORC1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.

Primary outcomes:
measure: therapeutic INR range (TTR) 90
timeFrame: at Day90
Secondary outcomes:
measure: therapeutic INR range (TTR) 28
timeFrame: at Day28
measure: Time of the first time of the target INR
timeFrame: 90 days
Other outcomes:
measure: thrombus or embolism or bleeding complications
timeFrame: 90 days
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fuwai Hospital
state: Beijing
Study officials:
affiliation: Thrombosis and Vascular Medicine Center
name: Lu Hua, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: