Genotype-guided Versus Standard for Warfarin Dosing

NCT03479684 | Completed DMC

• 1 other identifier: Z171100001017216
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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。

Conditions

Atrial Fibrillation; Valvular Heart Disease

Keywords

warfarin; gene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• therapeutic INR range (TTR) 28

  at Day28

• Time of the first time of the target INR

  90 days

Other Outcomes (1)

• thrombus or embolism or bleeding complications

  90 days

Study Arms (2)

Gene-directed group

EXPERIMENTAL

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

Other: Gene-directed dosage of warfarin

Standard care group

ACTIVE COMPARATOR

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

Other: standard dosage of warfarin

Interventions

Gene-directed dosage of warfarin 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

Gene-directed group

standard dosage of warfarin OTHER

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

Standard care group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lu Hua, MD. PhD

  Thrombosis and Vascular Medicine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician of Thrombosis and Vascular Medicine Center Fuwai Hospitai

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 27, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)