Gene-guided Warfarin for Anticoagulation Therapy (GWAT)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Device: Gene detection (CYP2C9*3, VKORC1); Drug: Warfarin Sodium

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gene-guided Warfarin	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.
Other: Routine use	Drug: Warfarin Sodium; Warfarin is administered at a gene-guided dose or at a regular dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 19, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Anticoagulants; Warfarin
• Other Study ID Numbers: XJTU1AF2020LSK-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No