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Gene-guided Warfarin for Anticoagulation Therapy (GWAT)

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gene detection (CYP2C9*3, VKORC1)
Warfarin Sodium
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Gene-guided Warfarin

    Routine use

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2020
    Last Updated
    August 22, 2021
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04482842
    Brief Title
    Gene-guided Warfarin for Anticoagulation Therapy
    Acronym
    GWAT
    Official Title
    Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    December 10, 2020 (Actual)
    Primary Completion Date
    August 20, 2021 (Actual)
    Study Completion Date
    August 20, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gene-guided Warfarin
    Arm Type
    Experimental
    Arm Title
    Routine use
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Gene detection (CYP2C9*3, VKORC1)
    Intervention Description
    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
    Drug
    Intervention Name(s)
    Warfarin Sodium
    Intervention Description
    Warfarin is administered at a gene-guided dose or at a regular dose.
    Primary Outcome Measure Information:
    Title
    Stroke recurrence rate, compliance rate of INR value
    Description
    Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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