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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Butylphthalide
DrugButylphthalide (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
Placebo
DrugMatching 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: ButylphthalideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
All cause mortality
The number of participants who experience all-cause mortality at 12 months. All-cause mortality includes death from any reason, such as cardiovascular, neurological, or other systemic causes.
Time frame
12 months2
Stroke recurrence
The number of participants who experience a recurrent stroke within 12 months. Recurrent stroke is defined as a new ischemic or hemorrhagic stroke, confirmed by neurological symptoms lasting ≥24 hours and neuroimaging evidence (MRI or CT)
Time frame
12 months3
Modified Rankin Scale (mRS) Score ≥2
The proportion of participants with a modified Rankin Scale (mRS) score ≥2 at 12 months. The mRS is a widely used functional outcome measure that assesses the degree of disability or dependence in daily activities following a stroke. The scale ranges from 0 (no symptoms) to 6 (death), with scores of 2 or higher indicating functional dependence.
Time frame
12 months4
New MRI-Confirmed Infarcts
The number of new infarcts confirmed by MRI at 12 months, compared to baseline. New infarcts are defined as newly developed ischemic lesions identified on diffusion-weighted imaging (DWI) or fluid-attenuated inversion recovery (FLAIR) sequences. A higher number of new infarcts indicates increased disease progression.
Time frame
12 monthsSecondary outcomes
1
All cause mortality
The number of participants who experience all-cause mortality at 12 months. All-cause mortality includes death from any reason, such as cardiovascular, neurological, or other systemic causes.
Time frame
12 months2
Stroke Recurrence
The number of participants who experience a recurrent stroke within 12 months. Recurrent stroke is defined as a new ischemic or hemorrhagic stroke, confirmed by neurological symptoms lasting ≥24 hours and neuroimaging evidence (MRI or CT)
Time frame
12 months3
Distribution of Modified Rankin Scale (mRS) Scores
The distribution of mRS scores among participants at 12 months. The mRS assesses the degree of disability or dependence in daily activities following a stroke, ranging from 0 (no symptoms) to 6 (death). The distribution of scores across the treatment and control groups will be analyzed.
Time frame
12 months4
New MRI-Confirmed Infarcts
The number of new infarcts confirmed by MRI at 12 months, compared to baseline. New infarcts are defined as newly developed ischemic lesions identified on diffusion-weighted imaging (DWI) or fluid-attenuated inversion recovery (FLAIR) sequences.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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