Ischemic StrokePhase 3BLESSNCT07230587
Butylphthalide for Long-term Efficacy in Minor Stroke Study
A Phase 3 study testing Butylphthalide in people with Ischemic Stroke and Minor Stroke, run by Peking Union Medical College Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke, Minor Stroke
- What is being tested?
- Butylphthalide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
- 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).
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- 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).
- 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).
- Severe systemic diseases with an expected survival < 1 year.
- Contraindications for MRI or inability to complete MRI scan.
- Allergy to butylphthalide.
- Pregnancy, lactation, or planned pregnancy.
- Participation in another clinical trial within 30 days before randomization.
- Deemed unsuitable for the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read more
The primary outcome is a hierarchical composite endpoint assessed at 12 months, including:
- All-cause mortality
- Stroke recurrence
- Modified Rankin Scale (mRS) score ≥2
- New MRI-confirmed infarcts
- 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.
Read the detailed description
- Background and Rationale Minor acute ischemic stroke accounts for a significant proportion of all ischemic strokes and is associated with a substantial risk of recurrent stroke and cognitive impairment. Despite advances in secondary stroke prevention, effective long-term treatments targeting both functional recovery and neuroprotection remain limited. Butylphthalide, a compound originally derived from celery seed, has demonstrated neuroprotective, anti-inflammatory, and microcirculatory-enhancing effects in preclinical and clinical studies. Previous trials have suggested its potential benefits in improving neurological function and preventing stroke progression. The BLESS Trial (Butylphthalide for Long-term Efficacy in Minor Stroke Study) is designed to evaluate the long-term efficacy and safety of butylphthalide in patients with minor acute ischemic stroke, focusing on its impact on functional outcomes, cognitive performance, and neuroimaging markers.
- Study Design and Methods This is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll approximately 1200 participants across 50 sites in China. Participants will be randomized in a 1:1 ratio to receive: Butylphthalide soft capsules (200 mg, three times daily) for 12 months, or Matching placebo for 12 months. Participants will undergo regular follow-ups with comprehensive assessments of clinical, cognitive, and imaging parameters.
- Primary Outcome Measure
A hierarchical composite endpoint assessed at 12 months using the Win Ratio method, prioritizing the following outcomes:
- All-cause mortality ②Stroke recurrence ③Modified Rankin Scale (mRS) score ≥2 ④New MRI-confirmed infarcts ⑤Change in Montreal Cognitive Assessment (MoCA) score from baseline 4.Secondary Outcome Measures
- All-cause mortality
- Recurrent stroke
- Modified Rankin Scale (mRS) score ≥2
- MRI-confirmed new infarcts
- Composite endpoint of ① + ② + ③
- Composite endpoint of ① + ② + ③ + ④
- Distribution of mRS scores ⑧ Change in MMSE score from baseline
- Change in MoCA score from baseline
- IADL score ⑪ Change in total Fazekas score of white matter hyperintensities from baseline ⑫ Change in white matter hyperintensity volume from baseline ⑬ Change in DTI parameters from baseline
- Statistical Analysis The Win Ratio method will be used for primary endpoint analysis, prioritizing mortality and severe disability outcomes. Secondary outcomes will be analyzed using Cox proportional hazards models, mixed-effects models, and logistic regression as appropriate. A significance level of P < 0.05 will be considered statistically significant. 6.Study Significance This study aims to determine whether butylphthalide can improve long-term functional and cognitive outcomes in minor stroke patients and provide a novel neuroprotective strategy for secondary stroke prevention. If successful, the findings could influence clinical guidelines for stroke management.
- Conditions
- Ischemic Stroke, Minor Stroke
- Being tested
- Butylphthalide, Placebo
- Keywords
- minor stroke, Butylphthalide
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButylphthalideDrug
Also called 3-n-Butylphthalide, NBP
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Butylphthalide | Experimental | Butylphthalide 200 mg (oral soft capsules), three times daily for 12 months Receives: Drug: Butylphthalide |
| Placebo | Placebo comparator | Placebo (matching oral soft capsules), three times daily for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
The change in Montreal Cognitive Assessment (MoCA) Score from baseline to 12 months. The MoCA is a cognitive screening tool that assesses multiple domains, including attention, concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: 12 months
Secondary outcomes (11)
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.
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Change in Mini-Mental State Examination (MMSE) Score from Baseline
The change in MMSE score from baseline to 12 months. The MMSE is a widely used cognitive screening tool that evaluates orientation, attention, memory, language, and visual-spatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: 12 months
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
The change in MoCA score from baseline to 12 months. The MoCA is a cognitive screening tool assessing attention, concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function
Measured: 12 months
Change in Instrumental Activities of Daily Living (IADL) Score
The change in IADL score from baseline to 12 months. The IADL measures the ability to perform more complex daily activities required for independent living, including managing finances, medication adherence, cooking, and housekeeping. Higher scores indicate greater independence
Measured: 12 months
Change in White Matter Hyperintensity (WMH) Fazekas Score from Baseline
The change in White Matter Hyperintensity (WMH) Fazekas Score from baseline to 12 months. The Fazekas scale is a validated measure of small vessel disease burden, ranging from 0 (no WMH) to 6 (severe WMH involvement)
Measured: 12 months
Change in White Matter Hyperintensity Volume from Baseline
The change in WMH volume from baseline to 12 months, assessed using quantitative MRI analysis. This measure evaluates the impact of treatment on the progression of small vessel disease. A decrease in WMH volume suggests treatment efficacy.
Measured: 12 months
Change in Diffusion Tensor Imaging (DTI) Parameters from Baseline
The change in DTI parameters from baseline to 12 months, including fractional anisotropy (FA) and mean diffusivity (MD). DTI is an MRI-based method for assessing white matter integrity and structural connectivity. Changes in FA and MD may reflect microstructural alterations associated with neuroprotection or disease progression.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230587
- Sponsor's protocol ID
- BLESS
- Other IDs
- 2023ZD0504900
- Acronym
- BLESS
- Status last verified
- Nov 2025
- First submitted
- 14 Jul 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan Z, Zhao Y, Yang W, He S, Ding Y, Xu A. Efficacy and Safety of Adherence to dl-3-n-Butylphthalide Treatment in Patients With Non-disabling Minor Stroke and TIA-Analysis From a Nationwide, Multicenter Registry. Front Neurol. 2021 Sep 22;12:720664. doi: 10.3389/fneur.2021.720664. eCollection 2021.
PubMed 34630292Amarenco P, Lavallee PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Kral M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.
PubMed 29766771
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07230587
- Acronym / sponsor ID
- BLESS / BLESS
- Conditions
- Ischemic Stroke, Minor Stroke
- Keywords
- minor stroke, Butylphthalide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- All-cause mortality
- Stroke recurrence
- Modified Rankin Scale (mRS) score ≥2
- New MRI-confirmed infarcts
- 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.
Detailed description
- Background and Rationale Minor acute ischemic stroke accounts for a significant proportion of all ischemic strokes and is associated with a substantial risk of recurrent stroke and cognitive impairment. Despite advances in secondary stroke prevention, effective long-term treatments targeting both functional recovery and neuroprotection remain limited. Butylphthalide, a compound originally derived from celery seed, has demonstrated neuroprotective, anti-inflammatory, and microcirculatory-enhancing effects in preclinical and clinical studies. Previous trials have suggested its potential benefits in improving neurological function and preventing stroke progression. The BLESS Trial (Butylphthalide for Long-term Efficacy in Minor Stroke Study) is designed to evaluate the long-term efficacy and safety of butylphthalide in patients with minor acute ischemic stroke, focusing on its impact on functional outcomes, cognitive performance, and neuroimaging markers.
- Study Design and Methods This is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll approximately 1200 participants across 50 sites in China. Participants will be randomized in a 1:1 ratio to receive: Butylphthalide soft capsules (200 mg, three times daily) for 12 months, or Matching placebo for 12 months. Participants will undergo regular follow-ups with comprehensive assessments of clinical, cognitive, and imaging parameters.
- Primary Outcome Measure
A hierarchical composite endpoint assessed at 12 months using the Win Ratio method, prioritizing the following outcomes:
- All-cause mortality ②Stroke recurrence ③Modified Rankin Scale (mRS) score ≥2 ④New MRI-confirmed infarcts ⑤Change in Montreal Cognitive Assessment (MoCA) score from baseline 4.Secondary Outcome Measures
- All-cause mortality
- Recurrent stroke
- Modified Rankin Scale (mRS) score ≥2
- MRI-confirmed new infarcts
- Composite endpoint of ① + ② + ③
- Composite endpoint of ① + ② + ③ + ④
- Distribution of mRS scores ⑧ Change in MMSE score from baseline
- Change in MoCA score from baseline
- IADL score ⑪ Change in total Fazekas score of white matter hyperintensities from baseline ⑫ Change in white matter hyperintensity volume from baseline ⑬ Change in DTI parameters from baseline
- Statistical Analysis The Win Ratio method will be used for primary endpoint analysis, prioritizing mortality and severe disability outcomes. Secondary outcomes will be analyzed using Cox proportional hazards models, mixed-effects models, and logistic regression as appropriate. A significance level of P < 0.05 will be considered statistically significant. 6.Study Significance This study aims to determine whether butylphthalide can improve long-term functional and cognitive outcomes in minor stroke patients and provide a novel neuroprotective strategy for secondary stroke prevention. If successful, the findings could influence clinical guidelines for stroke management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butylphthalide | Experimental | Drug: ButylphthalideButylphthalide 200 mg (oral soft capsules), three times daily for 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (matching oral soft capsules), three times daily for 12 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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).
- Neurological disorders causing cognitive impairment, such as CNS infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, traumatic brain injury, epilepsy, brain tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ButylphthalideAlso: 3-n-Butylphthalide, NBPButylphthalide (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 | Butylphthalide |
| PlaceboMatching 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. | Drug | Placebo |
Primary outcome
All cause mortality
Time frame: 12 months
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.
Stroke recurrence
Time frame: 12 months
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)
Modified Rankin Scale (mRS) Score ≥2
Time frame: 12 months
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.
New MRI-Confirmed Infarcts
Time frame: 12 months
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.
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
Time frame: 12 months
The change in Montreal Cognitive Assessment (MoCA) Score from baseline to 12 months. The MoCA is a cognitive screening tool that assesses multiple domains, including attention, concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function.
11 secondary outcomes
All cause mortality
Time frame: 12 months
Stroke Recurrence
Time frame: 12 months
Distribution of Modified Rankin Scale (mRS) Scores
Time frame: 12 months
New MRI-Confirmed Infarcts
Time frame: 12 months
Change in Mini-Mental State Examination (MMSE) Score from Baseline
Time frame: 12 months
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
Time frame: 12 months
Change in Instrumental Activities of Daily Living (IADL) Score
Time frame: 12 months
Change in White Matter Hyperintensity (WMH) Fazekas Score from Baseline
Time frame: 12 months
Change in White Matter Hyperintensity Volume from Baseline
Time frame: 12 months
Change in Diffusion Tensor Imaging (DTI) Parameters from Baseline
Time frame: 12 months
Modified Rankin Scale (mRS) score ≥2
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 34630292Tan Z, Zhao Y, Yang W, He S, Ding Y, Xu A. Efficacy and Safety of Adherence to dl-3-n-Butylphthalide Treatment in Patients With Non-disabling Minor Stroke and TIA-Analysis From a Nationwide, Multicenter Registry. Front Neurol. 2021 Sep 22;12:720664. doi: 10.3389/fneur.2021.720664. eCollection 2021.
- Results publication: PubMed 29766771Amarenco P, Lavallee PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Kral M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Butylphthalide in people with Ischemic Stroke and Minor Stroke, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YiCheng Zhu, Doctor ((+86)01069156380, zhuych910@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07230587, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.