Study Results
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Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-12-01
2026-07-20
Brief Summary
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Detailed Description
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the study will include 200 post-circulation AIS patients who will undergo randomization and divided into two groups; The (A) group, which consisted of 100 patients who administered (a 4 gram of acetyl-leucine per day) and the (B) group, which had 100 patients who administered a placebo during the first 24 hours of stroke onset and for 3 months.
Both groups received (open-label 300 mg loading dose aspirin and 300 mg loading clopidogrel during the first 24 hours of stroke onset, followed by 75 mg clopidogrel and 100 mg aspirin once daily from the 2nd to the 90th day.
The diagnosis of ischemic stroke was established through a detailed clinical history and examination and suitable brain imaging. All of the patients had CT of the brain and CT angiography (CTA) including the aortic arch through the circle of Willis before thrombolysis; the CT of the brain was performed on the 64-slice dual-source spiral CT scanner of Somatom definition by Siemens, and the supratentorial compartment scans were imaged with 5-8mm contiguous sections and the brain stem and cerebellum scans were imaged with 3-5mm slices, and we obtained eighteen images for each series. After thrombolysis, all of the patients underwent an MRI brain on a 1.5 T (Siemens Essenza) MR system, stroke protocol: T1W, T2W, fluid attenuation inversion recovery imaging (FLAIR), diffusion-weighted imaging (DWI), T2 Echo Gradient, and MRA brain \& neck time of flight (TOF) if CTA was contraindicated; the investigators performed an additional brain CT scan after 24-36 hours to evaluate hemorrhagic transformation. (8), and considered hemorrhagic transformation symptomatic if the NIHSS score increased by 4 points or more. (9) The computed tomography (CT)/ magnetic resonance imaging (MRI) examinations were assessed in our study by two highly experienced professionals: a senior stroke physician and a senior radiologist.
the investigators identified posterior-circulation stroke (PCS) when ischemic occlusion affected basilar, posterior cerebral or vertebral arteries
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Our study will include 200 post-circulation AIS patients who will undergo randomization and divided into two groups; The (A) group, which consisted of 100 patients who administered (a 4 gram of acetyl-leucine per day) and the (B) group, which had 100 patients who administered a placebo during the first 24 hours of stroke onset and for 3 months.
Both groups received (open-label 300 mg loading dose aspirin and 300 mg loading clopidogrel during the first 24 hours of stroke onset, followed by 75 mg clopidogrel and 100 mg aspirin once daily from the 2nd to the 90th day.
TREATMENT
QUADRUPLE
We prepared Sequentially numbered 200 labels for each Drug A or B. According to the randomisation chart. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included acetyl-leucine , and Drug B included placebo. Both groups received an open-label 300 mg loading dose aspirin and 300 mg loading clopidogrel during the first 24 hours of stroke onset, followed by 75 mg clopidogrel and 100 mg aspirin once daily from the 2nd to the 90th day.
Study Groups
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acetyl-leucine
The acetyl-leucine arm will receive (a 4 gram of acetyl-leucine daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Acetyl-Leucine
The acetyl-leucine arm will receive (a 4 gram of acetyl-leucine daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Clopidogrel 75 Mg Oral Tablet
All patients received an open-label loading 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 75 mg clopidogrel once daily.
aspirin 100mg
All patients received an open-label loading 300 mg aspirin during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin once daily.
placebo
The placebo arm will receive 4 gram placebo daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Placebo
The placebo arm will receive (a 4 gram of placebo daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Clopidogrel 75 Mg Oral Tablet
All patients received an open-label loading 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 75 mg clopidogrel once daily.
aspirin 100mg
All patients received an open-label loading 300 mg aspirin during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin once daily.
Interventions
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Acetyl-Leucine
The acetyl-leucine arm will receive (a 4 gram of acetyl-leucine daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Placebo
The placebo arm will receive (a 4 gram of placebo daily for three months and an open-label loading 300 mg aspirin and 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin and 75 mg clopidogrel.
Clopidogrel 75 Mg Oral Tablet
All patients received an open-label loading 300 mg clopidogrel during the first 24 hours of stroke, followed by a maintenance dose of 75 mg clopidogrel once daily.
aspirin 100mg
All patients received an open-label loading 300 mg aspirin during the first 24 hours of stroke, followed by a maintenance dose of 100 mg aspirin once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All of our patients underwent randomisation during the first 24 hours of the symptoms' onset, and within the first 24 hours from the time at which the patient's condition was last reported to be normal for wake-up stroke patients.
Exclusion Criteria
* the investigators ruled out participants who suffered from neurological diseases associated with recurrent neurological deficits, such as (epilepsy, multiple sclerosis, head trauma followed by neurological deficit).
* the investigators excluded participants who underwent intravenous thrombolysis, carotid, cerebrovascular, or coronary revascularization during the first week of the trial to avoid clouding of efficacy and safety analysis.
* the investigators excluded patients who experienced recurrent ischemic stroke detected from their clinical data and/or magnetic resonance imaging (MRI) brain findings. In addition, we excluded participants who experienced hypersensitivity to the study treatment
* the investigators excluded participants who experienced organ failure such as renal failure and liver cell failure, active malignancies, and patients with a known bleeding diathesis or coagulation disorder, a history of intracerebral hemorrhage, gastrointestinal bleeding within the past 6 months, or major surgery within 30 days before randomisation .
the investigators excluded pregnant and lactating women, patients with cerebral venous thrombosis, and patients with stroke associated with cardiac arrest.
18 Years
80 Years
ALL
No
Sponsors
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Kafrelsheikh University
OTHER
Responsible Party
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Mohamed G. zeinhom, MD
Dr
Principal Investigators
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Mohamed G. Zeinhom, MD
Role: STUDY_DIRECTOR
neurology department kafr el-sheikh university
Locations
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Kafr Elsheikh University Hospital
Kafr ash Shaykh, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Paciaroni M, Ince B, Hu B, Jeng JS, Kutluk K, Liu L, Lou M, Parfenov V, Wong KSL, Zamani B, Paek D, Min Han J, Del Aguila M, Girotra S. Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis. Cardiovasc Ther. 2019 Dec 1;2019:1607181. doi: 10.1155/2019/1607181. eCollection 2019.
Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.
Other Identifiers
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19012025
Identifier Type: -
Identifier Source: org_study_id
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