Gene-guided Warfarin for Anticoagulation Therapy

NCT ID: NCT04482842

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Gene-guided Warfarin

Group Type EXPERIMENTAL

Gene detection (CYP2C9*3, VKORC1)

Intervention Type DEVICE

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.

Warfarin Sodium

Intervention Type DRUG

Warfarin is administered at a gene-guided dose or at a regular dose.

Routine use

Group Type OTHER

Warfarin Sodium

Intervention Type DRUG

Warfarin is administered at a gene-guided dose or at a regular dose.

Interventions

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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.

Intervention Type DEVICE

Warfarin Sodium

Warfarin is administered at a gene-guided dose or at a regular dose.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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XJTU1AF2020LSK-067

Identifier Type: -

Identifier Source: org_study_id

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