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
About this trial
This is an interventional treatment trial for Stroke
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.
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
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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