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 range40 Years – 80 Years
SexALL
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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
✕. 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).