<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/NCT03266731</url>
  </required_header>
  <id_info>
    <org_study_id>ROAITOAIS</org_study_id>
    <nct_id>NCT03266731</nct_id>
  </id_info>
  <brief_title>Role of Anti-platelet in Treatment of Acute Ischemic Stroke</brief_title>
  <official_title>Role of Anti-platelet in Treatment of Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Role of anti-platelet in treatment of acute ischemic stroke to determine the safety of&#xD;
      immediate anti-platelet therapy .that is started as soon as possible within the first 24&#xD;
      hours of the onset of symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2015, stroke was the second most frequent cause of death after coronary artery disease,&#xD;
      accounting for 6.3 million deaths (11% of the total).Studies have reported a 30-day&#xD;
      recurrence rate of 1.1 to 15 % after stroke and as high as 17% after transient ischemic&#xD;
      attack .Therefore, early initiation of antiplatelet agents in ischemic stroke and patients is&#xD;
      important to prevent stroke recurrence and is tracked as a quality measure by organizations&#xD;
      that accredit stroke centers . Intravenous thrombolysis with alteplase is the mainstay&#xD;
      medical treatment for acute ischemic stroke. given intravenously within 4.5 hours of symptom&#xD;
      onset, to reopen occluded intracerebral arteries. As in fact most patients with ischemic&#xD;
      stroke present to the emergency department beyond the approved time window for thrombolytic&#xD;
      or other revascularization therapies beside their high cost and at this time, there are no&#xD;
      approved urgent therapies for most of these patients In addition, those who present with&#xD;
      rapidly resolving deficit or low National Institutes of Health stroke scale score are&#xD;
      generally not considered for thrombolytic treatment, although approximately one third of them&#xD;
      may be at high risk for neurological deterioration and recurrent vascular events.This study&#xD;
      will evaluates the safety and efficacy of clopidogrel and aspirin in treatment of patients&#xD;
      not eligible for recombinant tissue plasminogen activator or any other acute reperfusion&#xD;
      therapy with acute ischemic stroke and transient ischemic attack within 24 hours of symptoms&#xD;
      onset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 4, 2018</start_date>
  <completion_date type="Anticipated">January 4, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 4, 2019</primary_completion_date>
  <phase>N/A</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>A clinically significant neurologic deterioration</measure>
    <time_frame>24 hours</time_frame>
    <description>NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>use of aspirin and clopidogrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>evaluates the safety and efficacy of clopidogrel and aspirin as an alternative treatment in patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke (AIS) and transient ischemic attack (TIA) within 24 hours of symptoms onset</description>
    <arm_group_label>use of aspirin and clopidogrel</arm_group_label>
    <other_name>clopidogrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of the patients is 40 years or older.&#xD;
&#xD;
          2. Patients not eligible for recombinant tissue plasminogen activator or any other acute&#xD;
             reperfusion therapy presenting after 6hours of onset of symptoms.&#xD;
&#xD;
          3. Patients presented with clinical symptoms of acute stroke or TIA with onset less than&#xD;
             24 hours before starting any treatment.&#xD;
&#xD;
          4. The diagnosis of stroke or TIA basing on clinical examination using National Institute&#xD;
             of Health stroke scale (NIHSS) by a stroke specialist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any history of ICH or systemic hemorrhage.&#xD;
&#xD;
          2. Any evidence of hemorrhage on baseline CT brain imaging.&#xD;
&#xD;
          3. Patients presented with failed medical or surgical thrombectomy.&#xD;
&#xD;
          4. International normalized ratio (INR) more than 1.5.&#xD;
&#xD;
          5. History of allergy to aspirin or clopidogrel or both of them.&#xD;
&#xD;
          6. Platelets count less than 100,000/mm3.&#xD;
&#xD;
          7. Hematocrit less than 30 mg/dL .&#xD;
&#xD;
          8. glucose less than 50 mg/dL or greater than 400 mg/dL.to exclude hypoglycemia induced&#xD;
             focal neurological deficit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>hassan farweez, professor</last_name>
    <phone>01221741465</phone>
    <email>hassan.farwez@med.au.edu.eg</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Tharwat</investigator_full_name>
    <investigator_title>principal investigator</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>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03266731
org study id: ROAITOAIS
nct id: NCT03266731
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Role of anti-platelet in treatment of acute ischemic stroke to determine the safety of
      immediate anti-platelet therapy .that is started as soon as possible within the first 24
      hours of the onset of symptoms.
In 2015, stroke was the second most frequent cause of death after coronary artery disease,
      accounting for 6.3 million deaths (11% of the total).Studies have reported a 30-day
      recurrence rate of 1.1 to 15 % after stroke and as high as 17% after transient ischemic
      attack .Therefore, early initiation of antiplatelet agents in ischemic stroke and patients is
      important to prevent stroke recurrence and is tracked as a quality measure by organizations
      that accredit stroke centers . Intravenous thrombolysis with alteplase is the mainstay
      medical treatment for acute ischemic stroke. given intravenously within 4.5 hours of symptom
      onset, to reopen occluded intracerebral arteries. As in fact most patients with ischemic
      stroke present to the emergency department beyond the approved time window for thrombolytic
      or other revascularization therapies beside their high cost and at this time, there are no
      approved urgent therapies for most of these patients In addition, those who present with
      rapidly resolving deficit or low National Institutes of Health stroke scale score are
      generally not considered for thrombolytic treatment, although approximately one third of them
      may be at high risk for neurological deterioration and recurrent vascular events.This study
      will evaluates the safety and efficacy of clopidogrel and aspirin in treatment of patients
      not eligible for recombinant tissue plasminogen activator or any other acute reperfusion
      therapy with acute ischemic stroke and transient ischemic attack within 24 hours of symptoms
      onset.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A clinically significant neurologic deterioration
time frame: 24 hours
description: NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.
arm group label: use of aspirin and clopidogrel
arm group type: Experimental
intervention type: Drug
intervention name: Aspirin
description: evaluates the safety and efficacy of clopidogrel and aspirin as an alternative treatment in patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke (AIS) and transient ischemic attack (TIA) within 24 hours of symptoms onset
arm group label: use of aspirin and clopidogrel
other name: clopidogrel
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: hassan farweez, professor
phone: 01221741465
email: hassan.farwez@med.au.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Tharwat
investigator title: principal investigator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Aspirin
mesh term: Clopidogrel
sharing ipd: Undecided