Gene-guided Warfarin for Anticoagulation Therapy

NCT04482842 | Withdrawn

• 1 other identifier: XJTU1AF2020LSK-067
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gene-guided Warfarin

EXPERIMENTAL

Device: Gene detection (CYP2C9*3, VKORC1); Drug: Warfarin Sodium

Routine use

OTHER

Drug: Warfarin Sodium

Interventions

Gene detection (CYP2C9*3, VKORC1) 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.

Gene-guided Warfarin

Warfarin Sodium DRUG

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

Gene-guided Warfarin; Routine use

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Stroke

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 23, 2020
• Study Start: December 10, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08