Genotype-guided Versus Standard for Warfarin Dosing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-31

Brief Summary

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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。

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Detailed Description

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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

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Atrial Fibrillation Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gene-directed group

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

Group Type EXPERIMENTAL

Gene-directed dosage of warfarin

Intervention Type OTHER

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 care group

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

Group Type ACTIVE_COMPARATOR

standard dosage of warfarin

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

standard dosage of warfarin

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No