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

September 25, 2023 updated by: Ahmed Saeed Mostafa, Assiut University
  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients presenting consecutively to the Department of Neurology of Assiut university Hospital with acute ischemic stroke whether new onset or recurrent. Acute ischemic stroke was defined as focal neurological deficit persisting for more than 24 h with evidence of cerebral infarction on neuroimaging (MRI brain). The time between stroke occurrence and admission to the hospital was 1-48 h.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical assessment of patients with ischemic stroke
Time Frame: 15-30 min

assessment of ischemic stroke patient using National Institute of Health Stroke Scale (NIHSS)which is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Score Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
15-30 min
detection of aspirin resistance prevalence between ischemic stroke patients as risk factors and prevention of its recurrence.
Time Frame: 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
7-10 days
clinical assessment of patients with ischemic stroke
Time Frame: 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
10-15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 28, 2021

First Submitted That Met QC Criteria

November 28, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aspirin resistance in stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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