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Role of Anti-platelet in Treatment of Acute Ischemic Stroke

NCT ID: NCT03266731

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2020-01-04

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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use of aspirin and clopidogrel

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

Interventions

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Aspirin

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

Intervention Type DRUG

Other Intervention Names

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clopidogrel

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Tharwat

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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hassan farweez, professor

Role: CONTACT

Phone: 01221741465

Email: [email protected]

Other Identifiers

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ROAITOAIS

Identifier Type: -

Identifier Source: org_study_id