Role of Anti-platelet in Treatment of Acute Ischemic Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Drug: Aspirin

• Registration Number: NCT03266731
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31
• Study Start: 2018-01-04
• Primary Completion: 2019-01-04
• Study Completion: 2020-01-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
use of aspirin and clopidogrel	Aspirin	-

Primary Outcome Measures

Name	Time	Method
A clinically significant neurologic deterioration	24 hours	NIHSS score to detect the outcome of the patients as a greater than or equal to 2-point decrease or a score of 0.