<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/NCT03772457</url>
  </required_header>
  <id_info>
    <org_study_id>InV HT RAF 1010</org_study_id>
    <nct_id>NCT03772457</nct_id>
  </id_info>
  <brief_title>Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban</brief_title>
  <official_title>To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taizhou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhuji People's hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaoxing People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinhua Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HaiyanPeople's hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wenzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Central Hospital of Lishui City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dongyang People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rui'an People's hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was aimed at patients with newly diagnosed stroke / TIA associated with&#xD;
      nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban&#xD;
      anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode&#xD;
      MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment</measure>
    <time_frame>14 days after enrolling</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Cerebrovascular Stroke</condition>
  <condition>Intracranial Hemorrhages</condition>
  <condition>Anticoagulant</condition>
  <condition>Matrix Metalloproteinases</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban</intervention_name>
    <description>new oral anticoagulant molecules which is the selective factor Xa inhibitor</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and&#xD;
        receiveRivaroxaban treatment in the in-patient ward.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, age≥18;&#xD;
&#xD;
          2. Were newly diagnosed asischemic stroke/TIA concomitant NVAF;&#xD;
&#xD;
          3. Prescribedand accept Rivaroxaban;&#xD;
&#xD;
          4. Sign thewritten informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Renal impairment (CrCl&lt;15 ml/min) or severe hepatic impairment.&#xD;
&#xD;
          2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the&#xD;
             ECASS definition).&#xD;
&#xD;
          3. Stroke or TIA caused by large artery atherosclerosis&#xD;
&#xD;
          4. Planned major surgery or invasive intervention&#xD;
&#xD;
          5. Active internal bleeding&#xD;
&#xD;
          6. Malignancy or other serious medical conditions with a life expectancy &lt;6 months&#xD;
&#xD;
          7. Allergery to Rivaroxaban&#xD;
&#xD;
          8. Pregnancy or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Lou, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Lou, PhD</last_name>
    <phone>13958007213</phone>
    <email>loumingxc@vip.sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MIN LOU, Ph.D.</last_name>
      <phone>8657187784811</phone>
      <email>loumingxc@vip.sina.com</email>
    </contact>
    <investigator>
      <last_name>MIN LOU, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 10, 2017</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 16, 2023</last_update_submitted>
  <last_update_submitted_qc>April 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</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>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03772457
org study id: InV HT RAF 1010
nct id: NCT03772457
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study was aimed at patients with newly diagnosed stroke / TIA associated with
      nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban
      anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode
      MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.
observational model: Cohort
time perspective: Prospective
measure: Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
time frame: 14 days after enrolling
intervention type: Drug
intervention name: Rivaroxaban
description: new oral anticoagulant molecules which is the selective factor Xa inhibitor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Min Lou, PhD
role: Study Chair
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Min Lou, PhD
phone: 13958007213
email: loumingxc@vip.sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Intracranial Hemorrhages
mesh term: Atrial Fibrillation
mesh term: Infarction
mesh term: Hemorrhage
mesh term: Rivaroxaban