<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482842</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2020LSK-067</org_study_id>
    <nct_id>NCT04482842</nct_id>
  </id_info>
  <brief_title>Gene-guided Warfarin for Anticoagulation Therapy</brief_title>
  <acronym>GWAT</acronym>
  <official_title>Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the effect of warfarin gene polymorphism on the effectiveness and&#xD;
      safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the&#xD;
      correlation between genetic testing and compliance rate of INR value. It will illustrate the&#xD;
      significance of gene-guided warfarin for administered dose to anticoagulation therapy in&#xD;
      patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose&#xD;
      prediction model suitable for such patients, and provide basis for the personalized&#xD;
      medication regimen of warfarin in patients with acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">December 10, 2020</start_date>
  <completion_date type="Actual">August 20, 2021</completion_date>
  <primary_completion_date type="Actual">August 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke recurrence rate, compliance rate of INR value</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Gene-guided Warfarin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine use</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gene detection (CYP2C9*3, VKORC1)</intervention_name>
    <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.</description>
    <arm_group_label>Gene-guided Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin Sodium</intervention_name>
    <description>Warfarin is administered at a gene-guided dose or at a regular dose.</description>
    <arm_group_label>Gene-guided Warfarin</arm_group_label>
    <arm_group_label>Routine use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism&#xD;
             patients)&#xD;
&#xD;
          -  Clinicians judge that long-term oral anticoagulation with warfarin is required&#xD;
&#xD;
          -  No anticoagulation treatment in the past 10 days&#xD;
&#xD;
          -  Agree to participate in this project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had a tendency to bleed when taking warfarin&#xD;
&#xD;
          -  High-risk groups using warfarin anticoagulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 22, 2021</last_update_submitted>
  <last_update_submitted_qc>August 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482842
org study id: XJTU1AF2020LSK-067
nct id: NCT04482842
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Stroke recurrence rate, compliance rate of INR value
time frame: 12 months
description: Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment
arm group label: Gene-guided Warfarin
arm group type: Experimental
arm group label: Routine use
arm group type: Other
intervention type: Device
intervention name: Gene detection (CYP2C9*3, VKORC1)
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.
arm group label: Gene-guided Warfarin
intervention type: Drug
intervention name: Warfarin Sodium
description: Warfarin is administered at a gene-guided dose or at a regular dose.
arm group label: Gene-guided Warfarin
arm group label: Routine use
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Stroke
mesh term: Warfarin
sharing ipd: Undecided