Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis.
Maurizio Paciaroni, Birsen Ince, Bo Hu...
https://pubmed.ncbi.nlm.nih.gov/31867054Actively Recruiting
Phase 3
Age: 18Years - 80Years
All Genders
ID07275749
The Safety and Efficacy of Acetyl-leucine in Post-stroke Ataxia: a Randomized Placebo-controlled Trial
Led by Kafrelsheikh University · Updated on 2025-12-10
200
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of taking 4 grams of acetyl-leucine daily for three months in patients who have post-stroke ataxia following a posterior-circulation ischemic stroke. This clinical trial is designed as a double-blinded, placebo-controlled study to compare acetyl-leucine with a placebo in improving balance and movement issues after stroke. The study is conducted at Kafr-Elsheikh University and includes 200 patients who recently experienced this type of stroke. Participants are randomly assigned to one of two groups. One group receives 4 grams of acetyl-leucine daily along with aspirin and clopidogrel as part of their stroke treatment, while the other group receives a placebo with the same aspirin and clopidogrel regimen. The aspirin and clopidogrel are given as a loading dose during the first 24 hours after stroke, followed by a maintenance dose daily for 90 days. The interventions begin within 24 hours of stroke onset and continue for three months. During the study, participants will undergo brain imaging scans including CT and MRI to confirm stroke diagnosis and monitor progress. Researchers will assess balance and ataxia using the Berg Balance Scale (BBS), Scale for the Assessment and Rating of Ataxia (SARA), and Modified Rankin Scale (mRS) at 90 days. They will also monitor for any treatment-related side effects. The study lasts for three months, with detailed evaluations and safety assessments throughout this period.
CONDITIONS
Brief Title
Acetyl-leucine in Post-stroke Ataxia
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 80 years
- First-ever posterior-circulation ischemic stroke
- Presence of gait ataxia with at least 1 point on gait, stance, trunk, or heel-shin-slide items of the Scale for the Assessment and Rating of Ataxia (SARA)
- Score of 47 points or less on the Berg Balance Scale (BBS)
- Randomization within 24 hours of symptom onset or last known normal time for wake-up strokes
You will not qualify if you...
- Modified Rankin Scale (mRS) score of 5 or more
- Physical or mental conditions preventing safe participation or influencing outcome assessment (e.g., dementia, altered consciousness, severe aphasia)
- Neurological diseases causing recurrent deficits (e.g., epilepsy, multiple sclerosis, head trauma with lasting deficit)
- Received intravenous thrombolysis or vascular revascularization within the first week of the trial
- History of recurrent ischemic stroke
- Hypersensitivity to study treatment
- Organ failure such as renal or liver failure
- Active malignancies
- Bleeding disorders, history of intracerebral hemorrhage, recent gastrointestinal bleeding, or major surgery within 30 days before randomization
- Pregnant or lactating women
- Cerebral venous thrombosis
- Stroke associated with cardiac arrest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive either 4 grams daily of acetyl-leucine or placebo for three months, alongside aspirin and clopidogrel medications starting within 24 hours of stroke onset.
Visits as needed for medication administration and monitoring during the treatment period
Follow-up
Duration - Up to 90 days after treatment starts
Participants are monitored for treatment-related side effects and assessment of balance and ataxia outcomes after treatment ends.
Approximately 1 to 2 visits for outcome assessments
Trial Site Locations
Total: 1 location
1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511
Actively Recruiting
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Research Team
M
Mohamed G. Zeinhom, MD
S
Sherihan rezk Ahmed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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