<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/NCT03749057</url>
  </required_header>
  <id_info>
    <org_study_id>k （2018）39</org_study_id>
    <nct_id>NCT03749057</nct_id>
  </id_info>
  <brief_title>Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation</brief_title>
  <acronym>ERSAF</acronym>
  <official_title>Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Shenyang Military Region</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral&#xD;
      infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and&#xD;
      national guidelines for the management of anticoagulation recommend that most of AF patients&#xD;
      with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days&#xD;
      of symptom onset, while European guidelines recommend that the timing of the initiation of&#xD;
      non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction&#xD;
      or TIA is association with stroke severity in light of the &quot;1-3-6-12&quot; principle. However,&#xD;
      there are still many problems about the use of NOACs in ischemic stroke with AF. for example,&#xD;
      it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity&#xD;
      with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks.&#xD;
      Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need&#xD;
      is to develop a guideline-based specific regimen in which the benefit-risk factors are&#xD;
      further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.&#xD;
&#xD;
      Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot.&#xD;
      ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of&#xD;
      warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased&#xD;
      bleeding risk compared with warfarin. Recent study indicates that early administration with&#xD;
      rivaroxaban for AF patients within 14 days of onset does not significantly increase&#xD;
      hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of&#xD;
      early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in&#xD;
      China.&#xD;
&#xD;
      Therefore, the investigators conduct a multicenter cohort study to investigate the safety of&#xD;
      early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of intracranial hemorrhage</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of early neurological deterioration</measure>
    <time_frame>7 days</time_frame>
    <description>2 or more increase in NIHSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence of stroke or other vascular events</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding event</measure>
    <time_frame>90 days</time_frame>
    <description>Any bleeding event except intracranial hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Cerebral Infarction</condition>
  <condition>TIA</condition>
  <arm_group>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>15-20 mg rivaroxaban daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban</intervention_name>
    <description>Rivaroxaban 15-20 mg daily</description>
    <arm_group_label>rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Over 18 years&#xD;
&#xD;
          2. Acute cerebral infarction caused by non-valvular atrial fibrillation&#xD;
&#xD;
          3. NIHSS score ≤ 15&#xD;
&#xD;
          4. Within 12 days of onset&#xD;
&#xD;
          5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)&#xD;
&#xD;
          6. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hemorrhagic stroke or mixed stroke&#xD;
&#xD;
          2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction&#xD;
&#xD;
          3. Patients with severe infection or serious diseases&#xD;
&#xD;
          4. Gastrointestinal bleeding or major operation within 3 months&#xD;
&#xD;
          5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months&#xD;
&#xD;
          6. Planed major surgery within 3 months&#xD;
&#xD;
          7. Participating in other clinical trials within 3 months&#xD;
&#xD;
          8. Unsuitable for this trial assessed by research&#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>Huisheng Chen, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Neurology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xinhong Wang, Doctor</last_name>
    <phone>15309885658</phone>
    <phone_ext>024-28897512</phone_ext>
    <email>450341972@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yu Cui, Master</last_name>
    <phone>18842398646</phone>
    <phone_ext>024-28897512</phone_ext>
    <email>314486939@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>General Hospital of ShenYang Military Region</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Wang, Master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>General Hospital of Shenyang Military Region</investigator_affiliation>
    <investigator_full_name>Hui-Sheng Chen</investigator_full_name>
    <investigator_title>Department Chairman</investigator_title>
  </responsible_party>
  <keyword>rivaroxaban</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Infarction</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/NCT03749057
org study id: k （2018）39
nct id: NCT03749057
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral
      infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and
      national guidelines for the management of anticoagulation recommend that most of AF patients
      with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days
      of symptom onset, while European guidelines recommend that the timing of the initiation of
      non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction
      or TIA is association with stroke severity in light of the "1-3-6-12" principle. However,
      there are still many problems about the use of NOACs in ischemic stroke with AF. for example,
      it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity
      with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks.
      Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need
      is to develop a guideline-based specific regimen in which the benefit-risk factors are
      further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.

      Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot.
      ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of
      warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased
      bleeding risk compared with warfarin. Recent study indicates that early administration with
      rivaroxaban for AF patients within 14 days of onset does not significantly increase
      hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of
      early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in
      China.

      Therefore, the investigators conduct a multicenter cohort study to investigate the safety of
      early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: incidence of intracranial hemorrhage
time frame: 7 days
measure: incidence of early neurological deterioration
time frame: 7 days
description: 2 or more increase in NIHSS
measure: recurrence of stroke or other vascular events
time frame: 90 days
measure: bleeding event
time frame: 90 days
description: Any bleeding event except intracranial hemorrhage
measure: Serious adverse events
time frame: 90 days
arm group label: rivaroxaban
arm group type: Other
description: 15-20 mg rivaroxaban daily
intervention type: Drug
intervention name: Rivaroxaban
description: Rivaroxaban 15-20 mg daily
arm group label: rivaroxaban
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Huisheng Chen, Doctor
role: Study Chair
affiliation: Neurology Department
last name: Xinhong Wang, Doctor
phone: 15309885658
phone ext: 024-28897512
email: 450341972@qq.com
last name: Yu Cui, Master
phone: 18842398646
phone ext: 024-28897512
email: 314486939@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: General Hospital of Shenyang Military Region
investigator full name: Hui-Sheng Chen
investigator title: Department Chairman
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Atrial Fibrillation
mesh term: Infarction
mesh term: Rivaroxaban