Butylphthalide for Long-term Efficacy in Minor Stroke Study (NCT07230587) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Butylphthalide for Long-term Efficacy in Minor Stroke Study
1,200 participantsStarted 2025-12-01
Plain-language summary
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the long-term efficacy and safety of butylphthalide in patients with minor acute ischemic stroke (BLESS Trial).
A total of 1200 participants aged 40 to 80 years with a minor acute ischemic stroke confirmed by MRI will be enrolled. Participants will be randomly assigned in a 1:1 ratio to receive butylphthalide or placebo for 12 months.
The primary outcome is a hierarchical composite endpoint assessed at 12 months, including:
1. All-cause mortality
2. Stroke recurrence
3. Modified Rankin Scale (mRS) score ≥2
4. New MRI-confirmed infarcts
5. Change in Montreal Cognitive Assessment (MoCA) score from baseline
Secondary outcomes include additional functional, cognitive, and imaging-based assessments at 12 months.
This study aims to determine whether butylphthalide can improve long-term functional and cognitive outcomes in patients with minor ischemic stroke, contributing to better secondary stroke prevention strategies.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 40 and 80 years old.
. NIHSS score 0-5 at the time of stroke diagnosis, with MRI-confirmed acute ischemic infarct.
. Time from stroke onset to enrollment ≤ 2 weeks.
. Pre-stroke mRS score ≤ 1.
. No prior diagnosis of cognitive impairment or dementia.
. Informed consent must be voluntarily signed by the patient or their legal representative.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All cause mortality
Timeframe: 12 months
2
Stroke recurrence
Timeframe: 12 months
3
Modified Rankin Scale (mRS) Score ≥2
Timeframe: 12 months
4
New MRI-Confirmed Infarcts
Timeframe: 12 months
5
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
. Based on the TOAST classification, consider cardioembolic stroke, stroke of other determined etiology, or stroke of undetermined etiology.
. Intracranial hemorrhagic diseases on imaging: hemorrhagic stroke, epidural hematoma, subarachnoid hemorrhage, etc. (If hemorrhagic transformation is present, eligibility is at investigator's discretion.)
. Pre-stroke diagnosis of severe psychiatric disorders, including but not limited to depression, non-vascular cognitive impairment, or dementia (e.g., Alzheimer's disease, Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, drug or alcohol-induced cognitive impairment).
. Severe hemiplegia and aphasia that significantly affect cognitive assessment.
. Use of cognitive-enhancing drugs within 4 weeks before screening, including cholinesterase inhibitors (donepezil, rivastigmine, galantamine), NMDA receptor antagonists (memantine), sodium oligomannate (GV-971), or monoclonal antibodies (lecanemab, donanemab, aducanumab).