Ischemic StrokeNCT05151263
Prevalence of Aspirin Resistance in Ischemic Stroke Patients at Assiut University Hospital
An observational study of Ischemic Stroke, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Acetyl Salicylate and Optical Platelet Aggregation test
- How many people
- 133 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with other neurological deficits due to stroke mimics or hemorrhagic insult.
- Patients is subjected to anticoagulant treatment (atrial fibrillation, valve replacement, others).
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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
- Being tested
- Acetyl Salicylate, Optical Platelet Aggregation test
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl SalicylateDrug
Also called aspirin
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
Optical Platelet Aggregation testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Measured: 10-15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Nov 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saeed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151263
- Sponsor's protocol ID
- aspirin resistance in stroke
- Status last verified
- Sep 2023
- First submitted
- 28 Nov 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18824358Feigin 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.
PubMed 15978910Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7.
PubMed 18468545Bogousslavsky 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.
PubMed 3413804Yip 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.
PubMed 16006760Antithrombotic 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.
PubMed 11786451Randomised 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.
PubMed 2899772Zimmermann 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.
PubMed 12874188Borna 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.
PubMed 16045804Kahraman 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.
PubMed 17218028Watala 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.
PubMed 15723265Fateh-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.
PubMed 15944844Gorog 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.
PubMed 19365406Lev 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.
PubMed 19232900MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Aspirin Resistance in Ischemic Stroke Patients at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05151263
- Acronym / sponsor ID
- aspirin resistance in stroke
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with other neurological deficits due to stroke mimics or hemorrhagic insult.
- Patients is subjected to anticoagulant treatment (atrial fibrillation, valve replacement, others).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl SalicylateAlso: aspirinAspirin 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 | Drug | – |
| Optical Platelet Aggregation testThe 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. | Diagnostic test | – |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 18824358Bennett 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.
- Background: PubMed 15978910Feigin 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.
- Background: PubMed 18468545Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet. 2008 May 10;371(9624):1612-23. doi: 10.1016/S0140-6736(08)60694-7.
- Background: PubMed 3413804Bogousslavsky 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.
- Background: PubMed 16006760Yip 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.
- Background: PubMed 11786451Antithrombotic 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.
- Background: PubMed 2899772Randomised 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.
- Background: PubMed 12874188Zimmermann 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.
- Background: PubMed 16045804Borna 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.
- Background: PubMed 17218028Kahraman 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.
- Background: PubMed 15723265Watala 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.
- Background: PubMed 15944844Fateh-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essam S Darwish, PE (01114571118, Essam.S.Darwish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical assessment of patients with ischemic stroke (time frame: 15-30 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151263, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.