Genotype-guided Versus Standard for Warfarin Dosing

Atrial Fibrillation Clinical Trial

Official title:

Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479684
• Other study ID #: Z171100001017216
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

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
• standard dosage of warfarin
the first day given 4.5mg; adjusted dose based on INR from the second day

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	thrombus or embolism or bleeding complications	The number of thrombus or embolism or any hemorrhage events for participants through the study completion will be collected and assessed at Day90.	90 days
Primary	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.	at Day90
Secondary	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.	at Day28
Secondary	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.	90 days