Butylphthalide for Long-term Efficacy in Minor Stroke Study
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.)
Carotid artery stenosis > 50% requiring surgical intervention.
Systemic diseases causing cognitive impairment (e.g., endocrine diseases, vitamin deficiency, systemic autoimmune diseases).
Trial design
Treatments tested in this trial
- Butylphthalide
- Placebo
Treatment groups
1,200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov