Role of Anti-platelet in Treatment of Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

Role of Anti-platelet in Treatment of Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03266731
• Other study ID #: ROAITOAIS
• Status: Not yet recruiting
• Phase: N/A
• First received: August 28, 2017
• Last updated: August 30, 2017
• Start date: January 4, 2018
• Est. completion date: January 4, 2020

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: hassan farweez, professor
• Phone: 01221741465
• Email: hassan.farwez[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 4, 2020
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours