Genotype-guided Versus Standard for Warfarin Dosing

China National Center for Cardiovascular Diseases560 enrolled

Overview

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。

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

560

Conditions

Atrial Fibrillation Valvular Heart Disease

Interventions

Gene-directed dosage of warfarinOTHER

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

standard dosage of warfarinOTHER

the first day given 4.5mg; adjusted dose based on INR from the second day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

therapeutic INR range (TTR) 90

The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day90, and the TTR of all patients will be reported.

Time frame: at Day90

Secondary Outcomes

therapeutic INR range (TTR) 28

The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day28, and the TTR of all patients will be reported.

Time frame: at Day28

Time of the first time of the target INR

Time of the first time for participants to reach the target INR will be collected and reported during the study.

Time frame: 90 days

Data from ClinicalTrials.gov

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