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

NCT05151263 | Unknown

• 1 other identifier: aspirin resistance in stroke
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• clinical assessment of patients with ischemic stroke

  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.

  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

  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

Interventions

Acetyl Salicylate DRUG

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

Also known as: aspirin

Optical Platelet Aggregation test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 7 days of aspirin therapy (acetylsalicylic acid, 100 mg daily) prior to stroke onset
• Within 24 h of experiencing a new focal or global neurological deficit.
• Evidence of new or old ischemic infarct on CT brain or magnetic resonance imaging (MRI).
• With informed consents.
• Presence or not previous cerebrovascular event as previous history of transient ischemic attack (TIA) before the onset of stroke.

You may not qualify if:

• Patients with other neurological deficits due to stroke mimics or hemorrhagic insult.
• Patients is subjected to anticoagulant treatment (atrial fibrillation, valve replacement, others).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (15)

• Bennett D, Yan B, Macgregor L, Eccleston D, Davis SM. A pilot study of resistance to aspirin in stroke patients. J Clin Neurosci. 2008 Nov;15(11):1204-9. doi: 10.1016/j.jocn.2008.01.006. Epub 2008 Sep 27.

  PMID: 18824358 BACKGROUND

• Feigin VL. Stroke epidemiology in the developing world. Lancet. 2005 Jun 25-Jul 1;365(9478):2160-1. doi: 10.1016/S0140-6736(05)66755-4. No abstract available.

  PMID: 15978910 BACKGROUND

• Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7.

  PMID: 18468545 BACKGROUND

• Bogousslavsky J, Van Melle G, Regli F. The Lausanne Stroke Registry: analysis of 1,000 consecutive patients with first stroke. Stroke. 1988 Sep;19(9):1083-92. doi: 10.1161/01.str.19.9.1083.

  PMID: 3413804 BACKGROUND

• Yip HK, Liou CW, Chang HW, Lan MY, Liu JS, Chen MC. Link between platelet activity and outcomes after an ischemic stroke. Cerebrovasc Dis. 2005;20(2):120-8. doi: 10.1159/000086802. Epub 2005 Jul 5.

  PMID: 16006760 BACKGROUND

• Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

  PMID: 11786451 BACKGROUND

• Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet. 1988 Aug 13;2(8607):349-60.

  PMID: 2899772 BACKGROUND

• Zimmermann N, Wenk A, Kim U, Kienzle P, Weber AA, Gams E, Schror K, Hohlfeld T. Functional and biochemical evaluation of platelet aspirin resistance after coronary artery bypass surgery. Circulation. 2003 Aug 5;108(5):542-7. doi: 10.1161/01.CIR.0000081770.51929.5A. Epub 2003 Jul 21.

  PMID: 12874188 BACKGROUND

• Borna C, Lazarowski E, van Heusden C, Ohlin H, Erlinge D. Resistance to aspirin is increased by ST-elevation myocardial infarction and correlates with adenosine diphosphate levels. Thromb J. 2005 Jul 26;3:10. doi: 10.1186/1477-9560-3-10.

  PMID: 16045804 BACKGROUND

• Kahraman G, Sahin T, Kilic T, Baytugan NZ, Agacdiken A, Ural E, Ural D, Komsuoglu B. The frequency of aspirin resistance and its risk factors in patients with metabolic syndrome. Int J Cardiol. 2007 Feb 14;115(3):391-6. doi: 10.1016/j.ijcard.2006.10.025. Epub 2007 Jan 9.

  PMID: 17218028 BACKGROUND

• Watala C, Pluta J, Golanski J, Rozalski M, Czyz M, Trojanowski Z, Drzewoski J. Increased protein glycation in diabetes mellitus is associated with decreased aspirin-mediated protein acetylation and reduced sensitivity of blood platelets to aspirin. J Mol Med (Berl). 2005 Feb;83(2):148-58. doi: 10.1007/s00109-004-0600-x. Epub 2004 Nov 10.

  PMID: 15723265 BACKGROUND

• Fateh-Moghadam S, Plockinger U, Cabeza N, Htun P, Reuter T, Ersel S, Gawaz M, Dietz R, Bocksch W. Prevalence of aspirin resistance in patients with type 2 diabetes. Acta Diabetol. 2005 Jun;42(2):99-103. doi: 10.1007/s00592-005-0186-y.

  PMID: 15944844 BACKGROUND

• Gorog DA, Sweeny JM, Fuster V. Antiplatelet drug 'resistance'. Part 2: laboratory resistance to antiplatelet drugs-fact or artifact? Nat Rev Cardiol. 2009 May;6(5):365-73. doi: 10.1038/nrcardio.2009.13. Epub 2009 Apr 14.

  PMID: 19365406 BACKGROUND

• Lev EI. Aspirin resistance transient laboratory finding or important clinical entity? J Am Coll Cardiol. 2009 Feb 24;53(8):678-80. doi: 10.1016/j.jacc.2008.11.018. No abstract available.

  PMID: 19232900 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Essam S Darwish, PE

CONTACT

01114571118; Essam.S.Darwish@gmail.com

amal M Aly tohamy, AP

CONTACT

01221783835; Amaltohamy@rocketmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 9, 2021
• Study Start: November 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: April 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

EG (1)