Gene-guided Warfarin for Anticoagulation Therapy

Stroke Clinical Trial

— GWAT  

Official title:

Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04482842
• Other study ID #: XJTU1AF2020LSK-067
• Status: Withdrawn
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with acute ischemic stroke aged =18 years (cardiogenic cerebral embolism patients)
• Clinicians judge that long-term oral anticoagulation with warfarin is required
• No anticoagulation treatment in the past 10 days
• Agree to participate in this project

Exclusion Criteria:

• Patients who had a tendency to bleed when taking warfarin
• High-risk groups using warfarin anticoagulation

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Gene detection (CYP2C9*3, VKORC1)
Warfarin is administered at the recommended dose by detecting CYP2C9*3 and VKORC1 gene polymorphismsand. The doctor adjusts the dosage according to the fluctuation of INR value in time.

Drug:
• Warfarin Sodium
Warfarin is administered at a gene-guided dose or at a regular dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke recurrence rate, compliance rate of INR value	Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment	12 months