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

Not yet recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT05151263
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-11-28
• Study First Posted: 2021-12-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26
• Study Start: 2023-11-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 133

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical assessment of patients with ischemic stroke	10-15 min	assessment of ischemic stroke patient using modified Rankin score (MRS).The scale runs from 0-6, running from perfect health without symptoms to death.; 0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead
detection of aspirin resistance prevalence between ischemic stroke patients as risk factors and prevention of its recurrence.	7-10 days	Prevalence of aspirin resistance between patients of acute new onset stroke are calculated .and among patients with recurrent stroke on aspirin antiplatelet therapy who has aspirin resistance as risk factor calculated. Patients with aspirin resistance shifted to other antiplatelet therapy and MRS (modified Rankin score) evaluated on discharge

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt