NCT07230587Not yet recruitingPhase 3
Butylphthalide for Long-term Efficacy in Minor Stroke Study
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Efficacy of Butylphthalide in Patients With Minor Acute Ischemic Stroke (BLESS)
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 14 Jul 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Stroke
- NCT number
- NCT07230587
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1200
- From 1 Dec 2025 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Carotid artery stenosis \> 50% requiring surgical intervention.
- Participation in another clinical trial within 30 days before randomization.
Other illness
- 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.)
- Systemic diseases causing cognitive impairment (e.g., endocrine diseases, vitamin deficiency, systemic autoimmune diseases).
- Neurological disorders causing cognitive impairment, such as CNS infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, traumatic brain injury, epilepsy, brain tumors.
- 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 systemic diseases with an expected survival \< 1 year.
- Allergy to butylphthalide.
Lab values
- 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).
- Severe liver disease (e.g., acute hepatitis, active chronic hepatitis, cirrhosis) or ALT/AST \> 2× ULN.
- Severe kidney disease or renal impairment (serum creatinine \> 1.5× ULN).
- Coagulation disorders or thrombocytopenia (platelet count \< 100 × 10⁹/L).
Other
- Severe hemiplegia and aphasia that significantly affect cognitive assessment.
- Contraindications for MRI or inability to complete MRI scan.
- Pregnancy, lactation, or planned pregnancy.
- Deemed unsuitable for the study by the investigator.
Criteria the registry did not label
- 1.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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.