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Genotype-guided Versus Standard for Warfarin Dosing

Primary Purpose

Atrial Fibrillation, Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gene-directed dosage of warfarin
standard dosage of warfarin
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring warfarin, gene

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Sciences Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gene-directed group

Standard care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
February 27, 2018
Last Updated
April 28, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03479684
Brief Title
Genotype-guided Versus Standard for Warfarin Dosing
Official Title
Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Valvular Heart Disease
Keywords
warfarin, gene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gene-directed group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
the first day given 4.5mg; adjusted dose based on INR from the second day
Intervention Type
Other
Intervention Name(s)
Gene-directed dosage of warfarin
Intervention Description
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
Intervention Name(s)
standard dosage of warfarin
Intervention Description
the first day given 4.5mg; adjusted dose based on INR from the second day
Primary Outcome Measure Information:
Title
therapeutic INR range (TTR) 90
Description
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 Outcome Measure Information:
Title
therapeutic INR range (TTR) 28
Description
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
Title
Time of the first time of the target INR
Description
Time of the first time for participants to reach the target INR will be collected and reported during the study.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
thrombus or embolism or bleeding complications
Description
The number of thrombus or embolism or any hemorrhage events for participants through the study completion will be collected and assessed at Day90.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Hua, MD. PhD
Organizational Affiliation
Thrombosis and Vascular Medicine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Consent for sharing of non identifiable study data for regulatory authorities.

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Genotype-guided Versus Standard for Warfarin Dosing

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