<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/NCT02221102</url>
  </required_header>
  <id_info>
    <org_study_id>Xijing-Edoxaban</org_study_id>
    <nct_id>NCT02221102</nct_id>
  </id_info>
  <brief_title>Edoxaban for TIA and Acute Minor Stroke</brief_title>
  <official_title>Treatment of Edoxaban Versus Aspirin for Non-disabling Cerebrovascular Events: Rationale, Objectives, and Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent&#xD;
      stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and&#xD;
      slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral&#xD;
      anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying&#xD;
      significantly less risk of intracranial hemorrhage.&#xD;
&#xD;
      This trial is a randomized, double-blind, multicenter, controlled clinical trial in China.&#xD;
      The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to&#xD;
      aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular&#xD;
      event.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of patients with new stroke (ischemic or hemorrhage)</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6</measure>
    <time_frame>30 days and 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in NIHSS scores</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>moderate to severe bleeding events</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events/severe adverse events reported by the investigators</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">3700</enrollment>
  <condition>Ischemia</condition>
  <condition>Stroke</condition>
  <condition>Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>edoxaban 30mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>edoxaban 60mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>non-steroidal anti-inflammatory drugs</description>
    <arm_group_label>aspirin</arm_group_label>
    <other_name>Acetylsalicylic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>edoxaban</intervention_name>
    <description>orally active direct factor Xa inhibitor</description>
    <arm_group_label>edoxaban 30mg</arm_group_label>
    <arm_group_label>edoxaban 60mg</arm_group_label>
    <other_name>DU176b</other_name>
    <other_name>LIXIANA TABLETS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>aspirin</arm_group_label>
    <arm_group_label>edoxaban 30mg</arm_group_label>
    <arm_group_label>edoxaban 60mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult subjects (male or female ≥18 years old)&#xD;
&#xD;
          -  Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be&#xD;
             treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by&#xD;
             the &quot;last see normal&quot; principle&#xD;
&#xD;
          -  TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the&#xD;
             deficit within 24 hours of symptom onset), that can be treated with investigational&#xD;
             medication within 24 hours of symptoms onset. Symptom onset is defined by the &quot;last&#xD;
             see normal&quot; principle&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor,&#xD;
             abscess or other major nonischemic brain disease, on baseline head CT or MRI scan&#xD;
&#xD;
          -  mRS score &gt;2 at randomization (premorbid historical assessment)&#xD;
&#xD;
          -  NIHSS ≥4 at randomization&#xD;
&#xD;
          -  Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves,&#xD;
             deep venous thrombosis, pulmonary embolism or known hypercoagulable state)&#xD;
&#xD;
          -  Contraindication to investigational medications&#xD;
&#xD;
          -  Thrombolysis for ischemic stroke within preceding 7 days&#xD;
&#xD;
          -  History of intracranial hemorrhage&#xD;
&#xD;
          -  Current treatment (last dose given within 10 days before randomization) with heparin&#xD;
             therapy or oral anticoagulation&#xD;
&#xD;
          -  Gastrointestinal bleed or major surgery within 3 months&#xD;
&#xD;
          -  Planned or likely revascularization (any angioplasty or vascular surgery) within the&#xD;
             next 3 months&#xD;
&#xD;
          -  TIA or minor stroke induced by angiography or surgery&#xD;
&#xD;
          -  Severe noncardiovascular comorbidity with life expectancy &lt;3 months&#xD;
&#xD;
          -  Women of childbearing age not practicing reliable contraception who do not have a&#xD;
             documented negative pregnancy test result&#xD;
&#xD;
          -  Severe renal failure, defined as Glomerular Filtration Rate (GFR) &lt;30 ml/min -Severe&#xD;
             hepatic insufficiency (Child-Pugh score B to C)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gang Zhao, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Xijing hostipal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuedong Liu</last_name>
    <phone>+86 029 84775055</phone>
    <email>liuxued@fmmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Fang Yang, M.D. Ph.D.</last_name>
      <phone>+86 029 84773214</phone>
      <email>fyangx@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Gang Zhao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>edoxaban</keyword>
  <keyword>aspirin</keyword>
  <keyword>new oral anticoagulant</keyword>
  <keyword>TIA</keyword>
  <keyword>acute minor ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Edoxaban</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/NCT02221102
org study id: Xijing-Edoxaban
nct id: NCT02221102
lead sponsor: 
has dmc: Yes
Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent
      stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and
      slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral
      anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying
      significantly less risk of intracranial hemorrhage.

      This trial is a randomized, double-blind, multicenter, controlled clinical trial in China.
      The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to
      aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular
      event.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: percentage of patients with new stroke (ischemic or hemorrhage)
time frame: 90 days
measure: Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
time frame: 30 days
measure: mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6
time frame: 30 days and 90 days
measure: Changes in NIHSS scores
time frame: 90 days
measure: moderate to severe bleeding events
time frame: 90 days
measure: Total mortality
time frame: 90 days
measure: Adverse events/severe adverse events reported by the investigators
time frame: 90 days
arm group label: aspirin
arm group type: Active Comparator
description: Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30
arm group label: edoxaban 30mg
arm group type: Experimental
description: Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30
arm group label: edoxaban 60mg
arm group type: Experimental
description: Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30
intervention type: Drug
intervention name: Aspirin
description: non-steroidal anti-inflammatory drugs
arm group label: aspirin
other name: Acetylsalicylic acid
intervention type: Drug
intervention name: edoxaban
description: orally active direct factor Xa inhibitor
arm group label: edoxaban 30mg
arm group label: edoxaban 60mg
other name: DU176b
other name: LIXIANA TABLETS
intervention type: Drug
intervention name: placebo
arm group label: aspirin
arm group label: edoxaban 30mg
arm group label: edoxaban 60mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gang Zhao, M.D.
role: Study Chair
affiliation: Xijing hostipal
last name: Xuedong Liu
phone: +86 029 84775055
email: liuxued@fmmu.edu.cn
facility: 
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Stroke
mesh term: Cerebral Infarction
mesh term: Infarction
mesh term: Ischemia
mesh term: Aspirin
mesh term: Edoxaban