<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/NCT03806894</url>
  </required_header>
  <id_info>
    <org_study_id>0112-17-ZIV</org_study_id>
    <nct_id>NCT03806894</nct_id>
  </id_info>
  <brief_title>Clopidogrel Resistance in Stroke Patients From Different Ethnicities</brief_title>
  <official_title>Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to&#xD;
      clopidogrel has been reported among different population and may lead to reoccurring ischemic&#xD;
      events. The aim of the present study is to evaluate the incidence of clopidogrel resistance&#xD;
      in ischemic stroke patients from different ethnicities in Northern Israel and to find&#xD;
      different strategies to overcome high platelet reactivity including clopidogrel dose&#xD;
      adjustment or the choice of alternative agents. Quantification of platelet aggregation will&#xD;
      be determined by vasodilator stimulated phosphoprotein (VASP) assay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>Rates of clopidogrel resistance assessed among the different ethnicities</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Identifying of high-risk subgroups of adverse clinical outcomes</measure>
    <time_frame>6 to 12 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Clopidogrel, Poor Metabolism of</condition>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Jewish communities</arm_group_label>
    <description>Ashkenazi, Sephardi, Ethiopian</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arab populations</arm_group_label>
    <description>Muslim, Christian, Druze</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantification of platelet aggregation</intervention_name>
    <description>Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay</description>
    <arm_group_label>Arab populations</arm_group_label>
    <arm_group_label>Jewish communities</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This prospective study will be conducted in two sites (Ziv Medical Center, Safed,&#xD;
        department of neurology, and Galilee Medical Center, Nahariya, department of neurology) on&#xD;
        300 patients from different ethnic backgrounds with an ischemic cerebrovascular event&#xD;
        (ischemic stroke and TIA), treated with clopidrogel for secondary stroke prevention. The&#xD;
        groups will consist of Jewish communities (Ashkenazi, Sephardi and Ethiopian) and Arab&#xD;
        populations (Muslim, Christian and Druze).&#xD;
&#xD;
        To be considered eligible to participate in this study, patients have to be able to provide&#xD;
        signed and dated written informed consent or written assent from their relatives. Both&#xD;
        genders aged 18 and above are eligible for this trial. Pregnant patients will be excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide written informed consent and to be compliant with protocol&#xD;
             assessments.&#xD;
&#xD;
          2. Ages 18 and above inclusive&#xD;
&#xD;
          3. Both genders eligible for the study&#xD;
&#xD;
          4. Diagnosis of ischemic cerebrovascular event&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients will be excluded&#xD;
&#xD;
          2. Ages below 18&#xD;
&#xD;
          3. Patients not able to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziv Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Najib Dally</investigator_full_name>
    <investigator_title>Director of Hematology Department</investigator_title>
  </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>
  </condition_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/NCT03806894
org study id: 0112-17-ZIV
nct id: NCT03806894
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to
      clopidogrel has been reported among different population and may lead to reoccurring ischemic
      events. The aim of the present study is to evaluate the incidence of clopidogrel resistance
      in ischemic stroke patients from different ethnicities in Northern Israel and to find
      different strategies to overcome high platelet reactivity including clopidogrel dose
      adjustment or the choice of alternative agents. Quantification of platelet aggregation will
      be determined by vasodilator stimulated phosphoprotein (VASP) assay.
observational model: Cohort
time perspective: Prospective
measure: Rates of clopidogrel resistance assessed among the different ethnicities
time frame: 6 months
measure: Identifying of high-risk subgroups of adverse clinical outcomes
time frame: 6 to 12 months
arm group label: Jewish communities
description: Ashkenazi, Sephardi, Ethiopian
arm group label: Arab populations
description: Muslim, Christian, Druze
intervention type: Diagnostic Test
intervention name: Quantification of platelet aggregation
description: Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay
arm group label: Arab populations
arm group label: Jewish communities
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ziv Hospital
investigator full name: Dr. Najib Dally
investigator title: Director of Hematology Department
mesh term: Stroke
mesh term: Ischemic Stroke