<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/NCT03823274</url>
  </required_header>
  <id_info>
    <org_study_id>YMC037</org_study_id>
    <nct_id>NCT03823274</nct_id>
  </id_info>
  <brief_title>Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients</brief_title>
  <official_title>Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</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 cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet&#xD;
      resistance in ischemic stroke patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 3, 2022</completion_date>
  <primary_completion_date type="Actual">January 3, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>evaluate the relationship of stroke recurrence and anti-platelet resitance</measure>
    <time_frame>12weeks</time_frame>
    <description>To evaluate the relationship of stroke recurrence and anti-platelet resitance in ischemic stroke patients receiving aspirin 10mmg and clopidogrel 75mg for 12weeks</description>
  </primary_outcome>
  <enrollment type="Actual">1011</enrollment>
  <condition>Ischemic Stroke</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin, Clopidogrel</intervention_name>
    <description>to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stroke patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women over 60 years old at the time of written consent&#xD;
&#xD;
          2. Those admitted to the hospital within 72 hours after acute cerebral infarction and&#xD;
             treated with Aspirin 100 mg and Clopidogrel 75 mg&#xD;
&#xD;
          3. Written informed consent voluntarily signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with evidence other brain lesions such as brain tumors&#xD;
&#xD;
          2. Those who need oral anticoagulants other than vitamin K antagonists or anticoagulant&#xD;
             therapy of warfarin&#xD;
&#xD;
          3. Contraindicate to Aspirin or Clopidogrel or allergic to the drug&#xD;
&#xD;
          4. Subjects who are at risk of active pathological bleeding such as digestive ulcer and&#xD;
             intracranial hemorrhage&#xD;
&#xD;
          5. Cancer disease that can shorten life expectancy&#xD;
&#xD;
          6. Patient's condition that may interfere with participation in study such as mental&#xD;
             illness, mental retardation, dementia, drug abuse, and alcoholism&#xD;
&#xD;
          7. Subjects other than the above unsuitable for this clinical study identified by&#xD;
             Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jei Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National Universtity Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</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>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Clopidogrel</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/NCT03823274
org study id: YMC037
nct id: NCT03823274
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet
      resistance in ischemic stroke patients
observational model: Cohort
time perspective: Prospective
measure: evaluate the relationship of stroke recurrence and anti-platelet resitance
time frame: 12weeks
description: To evaluate the relationship of stroke recurrence and anti-platelet resitance in ischemic stroke patients receiving aspirin 10mmg and clopidogrel 75mg for 12weeks
intervention type: Drug
intervention name: Aspirin, Clopidogrel
description: to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: jei Kim
role: Principal Investigator
affiliation: Chungnam National Universtity Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Recurrence
mesh term: Aspirin
mesh term: Clopidogrel