Prevalence of Aspirin Resistance in Ischemic Stroke Patients at Assiut University Hospital

NCT ID: NCT05151263

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-04-01

Brief Summary

• This study aims to assess the prevalence of aspirin resistance in patients with acute ischemic stroke and its importance in secondary stroke prevention.
• Effect of aspirin resistance on short and long term mortality and detection of its relationship with recurrence of stroke.

Detailed Description

Stroke is the rapidly developing loss of brain functions due to disturbance in the blood supply to the brain. It is the leading cause of adult disability in the United States and Europe and currently the second leading cause of death, ranking after heart disease and before cancer, accounting for 10% of deaths worldwide . About 80-90% of strokes are caused by ischemia, and the remainder by hemorrhage . Arterioarterial micro thromboembolism is an important etiological factor in the pathogenesis of ischemic stroke. Platelet activation in cerebrovascular disease is associated with recurrent stroke and death, while inhibition of platelet function by antiplatelet drugs including aspirin lowers the risk of ischemic stroke. Aspirin is an effective antiplatelet agent, exhibiting its action by irreversibly inhibiting platelet cyclooxygenase-1 enzyme, thus preventing the production of thromboxane A2 (TXA2). It has been used in the primary and secondary prevention of thromboembolic vascular events. Yet, some patients experience recurrent ischemic events despite optimal antiplatelet therapy. This has raised the possibility that these patients may be resistant to aspirin and generated much interest in identification of such patients with laboratory tests of platelet function. Although many studies have demonstrated aspirin resistance in cardiovascular disorders including coronary artery disease, metabolic syndrome , and diabetes by certain tests of aspirin resistance, there are still concerns that these tests have not correlated closely with subsequent recurrent events, and have not reliably identified non-responders to antiplatelet therapy . In addition to the absence of any standardized approach to the diagnosis, there is currently no proven effective treatment for aspirin resistance. Although aspirin resistance has been demonstrated as a possible risk factor for recurrent cardiovascular ischemic events, there is a lack of data correlating aspirin resistance and risk of cerebrovascular ischemic events

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Acetyl Salicylate

Aspirin is an effective antiplatelet agent, exhibiting its action by irreversibly inhibiting platelet cyclooxygenase-1 enzyme, thus preventing the production of thromboxane A2 (TXA2). It has been used in the primary and secondary prevention of thromboembolic vascular events

Intervention Type: DRUG

Optical Platelet Aggregation test

The evaluation of platelet aggregation was performed using an optical aggregometer (AggRAM, using fresh citrated blood. Platelet-rich plasma was obtained by centrifugation of the citrated blood at 190 g for 5 min. The platelet count was adjusted to 200,000 to 300,000 platelets/mm3. Platelet-rich plasma (250 μl) was deposited in each equipment channel, and the activators adenosine diphosphate, epinephrine, collagen, and arachidonic acid were used according to the manufacturer's instructions. aspirin resistance was defined as platelet aggregation ≥ 20% with arachidonic acid and ≥70% with adenosine diphosphate.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

aspirin

Eligibility Criteria

Inclusion Criteria

1. At least 7 days of aspirin therapy (acetylsalicylic acid, 100 mg daily) prior to stroke onset

2. Within 24 h of experiencing a new focal or global neurological deficit.

3. Evidence of new or old ischemic infarct on CT brain or magnetic resonance imaging (MRI).

4. With informed consents.

5. Presence or not previous cerebrovascular event as previous history of transient ischemic attack (TIA) before the onset of stroke.

Exclusion Criteria

1. Patients with other neurological deficits due to stroke mimics or hemorrhagic insult.

2. Patients is subjected to anticoagulant treatment (atrial fibrillation, valve replacement, others).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Saeed Mostafa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Essam S Darwish, PE

Role: CONTACT

Essam.S.Darwish@gmail.com

01114571118

amal M Aly tohamy, AP

Role: CONTACT

Amaltohamy@rocketmail.com

01221783835

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Other Identifiers

aspirin resistance in stroke

Identifier Type: -

Identifier Source: org_study_id