MedPath

Genotype-guided Warfarin Individualized Treatment

Not Applicable
Completed
Conditions
Atrial Fibrillation
Deep Venous Thrombosis
Registration Number
NCT02211326
Lead Sponsor
The Third Xiangya Hospital of Central South University
Brief Summary

The purpose of this study is to determine whether the international pharmacogenetic algorithm is better than the standard initiation dosing and whether the two algorithms are suitable for Chinese elderly patients.

Detailed Description

The study protocol is a multicenter, randomized, patient-blinded and controlled trial, comparing two approaches among 864 enrolled AF(atrial fibrillation) or DVT(deep venous thrombosis) patients for guiding warfarin initial anticoagulation in Chinese elderly patients: the intervention group using the algorithm of International Warfarin Pharmacogenetic Consortium and its dose revision, and the control group using a standard initiation dose (2.25 mg).The study hypothesis is that the intervention group relative to the control group will increase the percentage of time in therapeutic INR (international normalized ratio) range during the first 3 months.This trial is the first prospective large-scale randomized controlled trial for elders in China. It is of great significance for promoting special crowd individualization of anticoagulants at home and abroad.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
660
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
%TTR12 weeks

percentage of time in the therapeutic INR (%TTR) of INR 2-3 (\<60 years old) or 1.5-2.5 (≥ 60 years old) within 12 weeks

Secondary Outcome Measures
NameTimeMethod
the time to reach therapeutic INR12 weeks

the time to reach therapeutic INR

the time to reach stable warfarin dose which defined as the dose to achieve INR within ±0.1 of therapeutic range at Day 8 post-dose12 weeks

the time to reach stable warfarin dose which defined as the dose to achieve INR within ±0.1 of therapeutic range at Day 8 post-dose

The number of adjustment units in the dose of warfarin (with 0.375 mg (1/8 tablet) as a unit); Incidence of INR ≥ 412 weeks

The number of adjustment units in the dose of warfarin (with 0.375 mg (1/8 tablet) as a unit); Incidence of INR ≥ 4

Trial Locations

Locations (15)

The People's Hospital of Hunan Province

🇨🇳

Changsha, Hunan, China

The Central Hospital of Changsha

🇨🇳

Changsha, Hunan, China

The Fourth Hospital of Changsha

🇨🇳

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The Third Hospital of Changsha

🇨🇳

Changsha, Hunan, China

The Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The First People's Hospital of Chenzhou

🇨🇳

Chenzhou, Hunan, China

The First Affiliated Hospital of Nanhua university

🇨🇳

Hengyang, Hunan, China

The Second Affiliated Hospital of Nanhua university

🇨🇳

Hengyang, Hunan, China

The Central Hospital of Loudi

🇨🇳

Loudi, Hunan, China

Scroll for more (5 remaining)
The People's Hospital of Hunan Province
🇨🇳Changsha, Hunan, China

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.