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Role of Anti-platelet in Treatment of Acute Ischemic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age of the patients is 40 years or older.
  2. Patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy presenting after 6hours of onset of symptoms.
  3. Patients presented with clinical symptoms of acute stroke or TIA with onset less than 24 hours before starting any treatment.
  4. The diagnosis of stroke or TIA basing on clinical examination using National Institute of Health stroke scale (NIHSS) by a stroke specialist

Exclusion Criteria:

  1. Any history of ICH or systemic hemorrhage.
  2. Any evidence of hemorrhage on baseline CT brain imaging.
  3. Patients presented with failed medical or surgical thrombectomy.
  4. International normalized ratio (INR) more than 1.5.
  5. History of allergy to aspirin or clopidogrel or both of them.
  6. Platelets count less than 100,000/mm3.
  7. Hematocrit less than 30 mg/dL .
  8. glucose less than 50 mg/dL or greater than 400 mg/dL.to exclude hypoglycemia induced focal neurological deficit.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    use of aspirin and clopidogrel

    Arm Description

    Outcomes

    Primary Outcome Measures

    A clinically significant neurologic deterioration
    NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 28, 2017
    Last Updated
    August 30, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03266731
    Brief Title
    Role of Anti-platelet in Treatment of Acute Ischemic Stroke
    Official Title
    Role of Anti-platelet in Treatment of Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 4, 2018 (Anticipated)
    Primary Completion Date
    January 4, 2019 (Anticipated)
    Study Completion Date
    January 4, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    use of aspirin and clopidogrel
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Other Intervention Name(s)
    clopidogrel
    Intervention 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
    Primary Outcome Measure Information:
    Title
    A clinically significant neurologic deterioration
    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.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age of the patients is 40 years or older. Patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy presenting after 6hours of onset of symptoms. Patients presented with clinical symptoms of acute stroke or TIA with onset less than 24 hours before starting any treatment. The diagnosis of stroke or TIA basing on clinical examination using National Institute of Health stroke scale (NIHSS) by a stroke specialist Exclusion Criteria: Any history of ICH or systemic hemorrhage. Any evidence of hemorrhage on baseline CT brain imaging. Patients presented with failed medical or surgical thrombectomy. International normalized ratio (INR) more than 1.5. History of allergy to aspirin or clopidogrel or both of them. Platelets count less than 100,000/mm3. Hematocrit less than 30 mg/dL . glucose less than 50 mg/dL or greater than 400 mg/dL.to exclude hypoglycemia induced focal neurological deficit.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hassan farweez, professor
    Phone
    01221741465
    Email
    hassan.farwez@med.au.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Role of Anti-platelet in Treatment of Acute Ischemic Stroke

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