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NCT07230587

PHASE3

Butylphthalide for Long-term Efficacy in Minor Stroke Study

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Efficacy of Butylphthalide in Patients With Minor Acute Ischemic Stroke (BLESS)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-12-01

Completion Date

2028-10-01

Last Updated

2025-11-17

Healthy Volunteers

Conditions

Ischemic Stroke Minor Stroke

Interventions

DRUG

Butylphthalide

Butylphthalide (NBP) is a neuroprotective agent derived from celery seed. It has demonstrated potential benefits in improving microcirculation, reducing oxidative stress, and protecting against neuronal injury in ischemic stroke. This study uses butylphthalide soft capsules (200 mg per dose) administered orally, three times daily for 12 months, to evaluate its long-term efficacy and safety in patients with minor acute ischemic stroke

DRUG

Placebo

Matching placebo soft capsules, identical in appearance to butylphthalide capsules, administered orally at a dose of one capsule (200 mg equivalent) three times daily for 12 months. The placebo contains inactive ingredients without pharmacological effects and is used as a control to assess the efficacy and safety of butylphthalide in patients with minor acute ischemic stroke.

1.Inclusion Criteria: 1. Age between 40 and 80 years old. 2. NIHSS score 0-5 at the time of stroke diagnosis, with MRI-confirmed acute ischemic infarct. 3. Time from stroke onset to enrollment ≤ 2 weeks. 4. Pre-stroke mRS score ≤ 1. 5. No prior diagnosis of cognitive impairment or dementia. 6. Informed consent must be voluntarily signed by the patient or their legal representative. Exclusion Criteria: 1. Based on the TOAST classification, consider cardioembolic stroke, stroke of other determined etiology, or stroke of undetermined etiology. 2. Intracranial hemorrhagic diseases on imaging: hemorrhagic stroke, epidural hematoma, subarachnoid hemorrhage, etc. (If hemorrhagic transformation is present, eligibility is at investigator's discretion.) 3. Carotid artery stenosis \> 50% requiring surgical intervention. 4. Systemic diseases causing cognitive impairment (e.g., endocrine diseases, vitamin deficiency, systemic autoimmune diseases). 5. Neurological disorders causing cognitive impairment, such as CNS infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, traumatic brain injury, epilepsy, brain tumors. 6. 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). 7. Severe hemiplegia and aphasia that significantly affect cognitive assessment. 8. 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). 9. Severe liver disease (e.g., acute hepatitis, active chronic hepatitis, cirrhosis) or ALT/AST \> 2× ULN. 10. Severe kidney disease or renal impairment (serum creatinine \> 1.5× ULN). 11. Coagulation disorders or thrombocytopenia (platelet count \< 100 × 10⁹/L). 12. Severe systemic diseases with an expected survival \< 1 year. 13. Contraindications for MRI or inability to complete MRI scan. 14. Allergy to butylphthalide. 15. Pregnancy, lactation, or planned pregnancy. 16. Participation in another clinical trial within 30 days before randomization. 17. Deemed unsuitable for the study by the investigator.

Clinical Research Directory

Butylphthalide for Long-term Efficacy in Minor Stroke Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria