Stroke, LacunarPhase 3NCT07252544
Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)
A Phase 3 study testing Isosorbide Mononitrate and Butylphthalide in people with Stroke, Lacunar and Stroke, Acute Ischemic, run by Beijing Tiantan Hospital.
Trial summary
The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke, Lacunar, Stroke, Acute Ischemic, Cerebral Small Vessel Diseases
- What is being tested?
- Isosorbide Mononitrate and Butylphthalide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,156 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 29 Feb 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years;
- Clinical lacunar syndrome within 7 days;
- Brain CT/MRI after symptom onset:
- a relevant (in time and location) acute lacunar infarct;
- if no relevant lesion, symptom duration >24 hours, with no other suspected stroke etiologies (such as cerebral hemorrhage, cortical infarction, seizures, etc.)
- MoCA score meeting the following criteria:
Show all 11Show fewer
- MoCA ≥ 13 if educated ≤ 6 years;
- MoCA ≥ 15 if 7 ≤ educated ≤ 12 years;
- MoCA ≥ 18 if educated ≥ 13 years；
- mRS ≤ 1 prior to this episode;
- Patient or a legally authorized representative signed informed consent.
Who cannot join
- Ischemic stroke of large artery atherosclerosis, cardioembolism, or other etiologies (TOAST classification);
- Diagnosed or suspected hereditary CSVD;
- Intracerebral hemorrhage within the past 3 months including parenchymal, intraventricular, subarachnoid hemorrhage, subdural/epidural hematoma;
- Neurodegenerative diseases or systemic diseases that may lead to cognitive impairment, such as Alzheimer's disease, mixed dementia, Parkinson's disease, systemic autoimmune diseases, hepatic encephalopathy, or uremic encephalopathy.
- Previously diagnosed psychiatric disorders (DSM-5 criteria).
- Other active neurological disorders (e.g., recurrent seizures, brain tumors, vascular malformations, untreated aneurysms >3 mm).
Show all 19Show fewer
- Hypotension (seated systolic blood pressure <100 mmHg), bradycardia (heart rate <60 bpm), sick sinus syndrome or severe cardiopulmonary disease.
- History of congestive heart failure, acute myocardial infarction or other severe cardiac dysfunctions (NYHA Class III-IV).
- Coagulation disorders, bleeding tendency or systemic bleeding, including but not limited to prothrombin time >3×upper limit of normal (ULN), platelet count <50×109/L, hemophilia, capillary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage, etc.
- Severe hepatic or renal insufficiency (note: severe hepatic insufficiency is defined as ALT or AST > 3×ULN or acute hepatitis, chronic active hepatitis, cirrhosis; severe renal insufficiency is defined as eGFR < 45 ml/min/1.73m², creatinine clearance < 40 ml/min, or known chronic kidney disease of stage 3 or higher).
- Head trauma, intracranial or spinal surgery, major surgical procedures or severe trauma within the past 4 weeks.
- ISMN or NBP use within the past 3 days.
- Have contraindications to ISMN or NBP, or allergy to their components.
- Have to use the contraindicated drugs of this trial for a long time.
- Pregnant, breastfeeding or planning to pregnant during this study.
- Unable to tolerate MRI or with MRI contraindications.
- Have severe diseases or expected survival <12 months.
- Participate in other clinical trials within 30 days before this trial.
- Unlikely to comply with study procedures and follow-up procedures for whatever reason in the opinion of the research physician.
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: Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke: a 2×2 Factorial Randomized Controlled Trial (IMPACT)
The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.
Read the detailed description
There is an urgent need for effective therapeutic strategies for acute ischemic cerebral small vessel disease (CSVD). Isosorbide mononitrate and butylphthalide may exert protective effects; however, large-scale randomized controlled trials are required to confirm their efficacy and safety and to guide clinical practice.
In this study, patients presenting with a clinical lacunar syndrome within 7 days of onset will be randomly assigned, in a 1:1:1:1 ratio, to one of four groups in addition to routine care: (1) isosorbide mononitrate plus butylphthalide, (2) isosorbide mononitrate plus butylphthalide placebo, (3) isosorbide mononitrate placebo plus butylphthalide, or (4) isosorbide mononitrate placebo plus butylphthalide placebo. The treatment period will last 6 months, with a total follow-up of 1 year, including assessments at 7 days, 1 month, 3 months, 6 months, and 1 year.
The primary efficacy outcome is post-stroke disability at 6 months. The primary safety outcome is moderate or more severe headache within 6 months.
- Being tested
- Isosorbide Mononitrate, Butylphthalide, Isosorbide Mononitrate Placebo, Butylphthalide Placebo
- Medical subject headings
- Stroke, Lacunar, Ischemic Stroke, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide MononitrateDrug
Days 1-7: Isosorbide mononitrate injection, 20 mg once daily by intravenous infusion.
Days 8-6 months: Isosorbide mononitrate sustained-release tablets, 40 mg once daily orally (dose reduced to 20 mg once daily during the final week).
ButylphthalideDrug
Days 1-7: Butylphthalide injection, 25 mg twice daily by intravenous infusion.
Days 8-6 months: Butylphthalide soft capsules, 200 mg three times daily orally.
Isosorbide Mononitrate PlaceboDrug
Days 1-7: Isosorbide mononitrate injection placebo, once daily by intravenous infusion.
Days 8-6 months: Isosorbide mononitrate sustained-release tablet placebo, once daily orally (dose reduced to half a tablet once daily during the final week).
Butylphthalide PlaceboDrug
Days 1-7: Butylphthalide injection placebo, twice daily by intravenous infusion.
Days 8-6 months: Butylphthalide soft capsule placebo, 2 capsules three times daily orally.
| Study group | Role | What they receive |
|---|---|---|
| isosorbide mononitrate plus butylphthalide | Experimental | Not described Receives: Drug: Isosorbide Mononitrate; Drug: Butylphthalide |
| isosorbide mononitrate plus butylphthalide placebo | Experimental | Not described Receives: Drug: Isosorbide Mononitrate; Drug: Butylphthalide Placebo |
| isosorbide mononitrate placebo plus butylphthalide | Experimental | Not described Receives: Drug: Butylphthalide; Drug: Isosorbide Mononitrate Placebo |
| isosorbide mononitrate placebo plus butylphthalide placebo | Placebo comparator | Not described Receives: Drug: Isosorbide Mononitrate Placebo; Drug: Butylphthalide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with post-stroke disability at 6 months
A composite endpoint defined as the occurrence of any of the following: modified Rankin Scale (mRS) score ≥ 3, major adverse cardiovascular events (MACE), cognitive impairment, or all-cause mortality. The mRS measures post-stroke functional outcome on a scale from 0 (no symptoms) to 6 (death). MACE includes non-fatal stroke, non-fatal myocardial infarction (MI), and vascular death.The assessment of cognitive function involves three stages: a cognitive screening test, supplementary cognitive testing, and adjudication by an expert panel. The Beijing version of the Montreal Cognitive Assessment (MoCA) is used as the cognitive screening scale. Scores on the MoCA range from 0 to 30, with lower scores indicating greater cognitive impairment.The supplementary cognitive assessment includes the evaluation of several domains: executive function, attention and processing speed, language, and memory, as well as activities of daily living.
Measured: 6 months
Incidence of moderate or more severe headache within 6 months
Headache severity is assessed using the Numerical Rating Scale (NRS), where: 0 indicates no pain; 1 represents a mild headache (including feelings of head pressure or throbbing that are not considered painful); a score of 4 or higher (≥4) represents a headache of at least moderate intensity; and 10 represents the worst headache imaginable to the subject.
Measured: 6 months
Secondary outcomes (10)
Proportion of participants with post-stroke disability at 1 year
The difinition of post-stroke disability is the same as the primary outcome measure.
Measured: 1 year
Proportion of participants with the modified Rankin Scale (mRS) score ≥ 3 at 6 months and 1 year
The modified Rankin Scale (mRS) is used to measure the degree of disability and dependence after a stroke. The scale ranges from 0 to 6. A score of 0 represents no symptoms, 1 represents no significant disability, 2 represents slight disability, 3 represents moderate disability, 4 represents moderately severe disability, 5 represents severe disability, and 6 represents death.
Measured: 6 months and 1 year
Incidence of recurrent stroke within 6 months and 1 year
Measured: 6 months and 1 year
Proportion of participants with dementia at 6 months and 1 year
Dementia (all of the following criteria must be met):
- Evidence of significant cognitive decline from a previous level of performance in one or more cognitive domains (complex attention, executive function, learning and memory, language, perceptual-motor, or social cognition) based on:1.Concern from the individual, a knowledgeable informant, or the clinician that there has been a significant decline in cognitive function. 2.A substantial impairment in cognitive performance, preferably documented by standardized neuropsychological testing or, in its absence, another quantified clinical assessment.
- The cognitive deficits interfere with independence in everyday activities (i.e., at a minimum, requiring assistance with complex instrumental activities of daily living, such as paying bills or managing medications).
- The cognitive deficits do not occur exclusively in the context of a delirium.
- The cognitive deficits are not better explained by another mental disorder.
Measured: 6 months and 1 year
National Institutes of Health Stroke Scale (NIHSS) scores at 7 days, 6 months, and 1 year (including changes from baseline)
The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively measure the severity of a stroke by quantifying a patient's neurological deficits. Its primary purposes are to evaluate the acuity of a stroke, guide treatment decisions, and predict patient outcomes. The scale's total score ranges from 0 to 42, with higher scores representing more severe neurological impairment.
Measured: baseline, 7 days, 6 months, and 1 year
Incidence of hypotension within 6 months
Hypotension is defined as a systolic blood pressure (SBP) of less than 100 mmHg or a 30% decrease from baseline.
Measured: 6 months
Incidence of syncope within 6 months
Syncope is a transient loss of consciousness caused by transient global cerebral hypoperfusion, characterized by a rapid onset, short duration, and spontaneous, complete recovery.
The diagnosis requires the following conditions to be met:
- A transient loss of consciousness with a rapid onset (from a few seconds to 1 minute);
- A short duration (from a few seconds to a few minutes);
- Spontaneous and complete recovery;
- Absence of focal neurological signs;
- Exclusion of head trauma and epileptic seizures.
Measured: 6 months
Incidence of liver function impairment within 6 months
Liver function impairment may be diagnosed if at least one of the following criteria is met:
- Serum AST or ALT > 5 × the upper limit of normal (ULN), or ALP > 2 × ULN (or from an abnormal baseline value);
- Serum total bilirubin (TBil) > 2.5 mg/dL (42.75 μmol/L) accompanied by any elevation in serum AST, ALT, or ALP levels.
Measured: 6 months
Incidence of any bleeding within 6 months
Bleeding events are evaluated using the GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) classification and categorized as severe, moderate, or mild.
Measured: 6 months
Incidence of symptomatic intracranial hemorrhage within 6 months
According to the Heidelberg Bleeding Classification established at the 12th Thrombolytic Therapy in Acute Ischemic Stroke workshop in Germany in 2015, symptomatic intracerebral hemorrhage (sICH) is defined as meeting all of the following conditions:
- Any form of intracranial hemorrhage (including types 1a, 1b, 1c, 2, 3a, 3b, 3c, and 3d of the Heidelberg classification) that is detected by imaging (head CT or MRI) and confirmed by a radiologist;
- The patient experiences clinical deterioration, defined as: an increase in the NIHSS score of ≥ 4 points from the last score prior to deterioration, OR an increase of ≥ 2 points on any single item of the NIHSS, OR an outcome leading to tracheal intubation, decompressive craniectomy, ventricular drainage, or other major medical/surgical intervention;
- The clinical deterioration cannot be explained by any cause other than the intracranial hemorrhage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, LacunarStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Yilong Wang, Principal investigator, Beiling Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252544
- Sponsor's protocol ID
- 2023ZD0504802
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke: a 2×2 Factorial Randomized Controlled Trial (IMPACT)
- ClinicalTrials.gov ID
- NCT07252544
- Acronym / sponsor ID
- 2023ZD0504802
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,156 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 26 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.
The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.
Detailed description
There is an urgent need for effective therapeutic strategies for acute ischemic cerebral small vessel disease (CSVD). Isosorbide mononitrate and butylphthalide may exert protective effects; however, large-scale randomized controlled trials are required to confirm their efficacy and safety and to guide clinical practice.
In this study, patients presenting with a clinical lacunar syndrome within 7 days of onset will be randomly assigned, in a 1:1:1:1 ratio, to one of four groups in addition to routine care: (1) isosorbide mononitrate plus butylphthalide, (2) isosorbide mononitrate plus butylphthalide placebo, (3) isosorbide mononitrate placebo plus butylphthalide, or (4) isosorbide mononitrate placebo plus butylphthalide placebo. The treatment period will last 6 months, with a total follow-up of 1 year, including assessments at 7 days, 1 month, 3 months, 6 months, and 1 year.
The primary efficacy outcome is post-stroke disability at 6 months. The primary safety outcome is moderate or more severe headache within 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| isosorbide mononitrate plus butylphthalide | Experimental | Drug: Isosorbide Mononitrate, Drug: Butylphthalide |
| isosorbide mononitrate plus butylphthalide placebo | Experimental | Drug: Isosorbide Mononitrate, Drug: Butylphthalide Placebo |
| isosorbide mononitrate placebo plus butylphthalide | Experimental | Drug: Butylphthalide, Drug: Isosorbide Mononitrate Placebo |
| isosorbide mononitrate placebo plus butylphthalide placebo | Placebo comparator | Drug: Isosorbide Mononitrate Placebo, Drug: Butylphthalide Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 30 years;
- Clinical lacunar syndrome within 7 days;
- Brain CT/MRI after symptom onset:
- MoCA score meeting the following criteria:
- mRS ≤ 1 prior to this episode;
Key exclusion criteria (19 listed)
- Ischemic stroke of large artery atherosclerosis, cardioembolism, or other etiologies (TOAST classification);
- Diagnosed or suspected hereditary CSVD;
- Intracerebral hemorrhage within the past 3 months including parenchymal, intraventricular, subarachnoid hemorrhage, subdural/epidural hematoma;
- Neurodegenerative diseases or systemic diseases that may lead to cognitive impairment, such as Alzheimer's disease, mixed dementia, Parkinson's disease, systemic autoimmune diseases, hepatic encephalopathy, or uremic encephalopathy.
- Previously diagnosed psychiatric disorders (DSM-5 criteria).
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 |
|---|---|---|
| Isosorbide MononitrateDays 1-7: Isosorbide mononitrate injection, 20 mg once daily by intravenous infusion. Days 8-6 months: Isosorbide mononitrate sustained-release tablets, 40 mg once daily orally (dose reduced to 20 mg once daily during the final week). | Drug | isosorbide mononitrate plus butylphthalide, isosorbide mononitrate plus butylphthalide placebo |
| ButylphthalideDays 1-7: Butylphthalide injection, 25 mg twice daily by intravenous infusion. Days 8-6 months: Butylphthalide soft capsules, 200 mg three times daily orally. | Drug | isosorbide mononitrate placebo plus butylphthalide, isosorbide mononitrate plus butylphthalide |
| Isosorbide Mononitrate PlaceboDays 1-7: Isosorbide mononitrate injection placebo, once daily by intravenous infusion. Days 8-6 months: Isosorbide mononitrate sustained-release tablet placebo, once daily orally (dose reduced to half a tablet once daily during the final week). | Drug | isosorbide mononitrate placebo plus butylphthalide, isosorbide mononitrate placebo plus butylphthalide placebo |
| Butylphthalide PlaceboDays 1-7: Butylphthalide injection placebo, twice daily by intravenous infusion. Days 8-6 months: Butylphthalide soft capsule placebo, 2 capsules three times daily orally. | Drug | isosorbide mononitrate placebo plus butylphthalide placebo, isosorbide mononitrate plus butylphthalide placebo |
Primary outcome
Proportion of participants with post-stroke disability at 6 months
Time frame: 6 months
A composite endpoint defined as the occurrence of any of the following: modified Rankin Scale (mRS) score ≥ 3, major adverse cardiovascular events (MACE), cognitive impairment, or all-cause mortality. The mRS measures post-stroke functional outcome on a scale from 0 (no symptoms) to 6 (death). MACE includes non-fatal stroke, non-fatal myocardial infarction (MI), and vascular death.The assessment of cognitive function involves three stages: a cognitive screening test, supplementary cognitive testing, and adjudication by an expert panel. The Beijing version of the Montreal Cognitive Assessment (MoCA) is used as the cognitive screening scale. Scores on the MoCA range from 0 to 30, with lower scores indicating greater cognitive impairment.The supplementary cognitive assessment includes the evaluation of several domains: executive function, attention and processing speed, language, and memory, as well as activities of daily living.
Incidence of moderate or more severe headache within 6 months
Time frame: 6 months
Headache severity is assessed using the Numerical Rating Scale (NRS), where: 0 indicates no pain; 1 represents a mild headache (including feelings of head pressure or throbbing that are not considered painful); a score of 4 or higher (≥4) represents a headache of at least moderate intensity; and 10 represents the worst headache imaginable to the subject.
10 secondary outcomes
Proportion of participants with post-stroke disability at 1 year
Time frame: 1 year
Proportion of participants with the modified Rankin Scale (mRS) score ≥ 3 at 6 months and 1 year
Time frame: 6 months and 1 year
Incidence of recurrent stroke within 6 months and 1 year
Time frame: 6 months and 1 year
Proportion of participants with dementia at 6 months and 1 year
Time frame: 6 months and 1 year
National Institutes of Health Stroke Scale (NIHSS) scores at 7 days, 6 months, and 1 year (including changes from baseline)
Time frame: baseline, 7 days, 6 months, and 1 year
Incidence of hypotension within 6 months
Time frame: 6 months
Incidence of syncope within 6 months
Time frame: 6 months
Incidence of liver function impairment within 6 months
Time frame: 6 months
Incidence of any bleeding within 6 months
Time frame: 6 months
Incidence of symptomatic intracranial hemorrhage within 6 months
Time frame: 6 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 26 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke, Lacunar
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
RecruitingPhase 4
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Lacunar Stroke, Stroke
RecruitingObservational study
Cerebral Small Vessel Disease Progression Dependent on Stroke Type
Cerebral Small Vessel Disease, Stroke
RecruitingObservational study
Retinal Vessel Leakage in Cerebral Small Vessel Disease
Cerebral Small Vessel Diseases, Lacunar Stroke
Recruiting
A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polyphenol-rich Salicornia Extract in the Progression of Cognitive Decline in a Cohort of Patients With Lacunar Infarcts (SALACUNAR)
Lacunar Stroke
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.
Yilong Wang principal investigator
Beiling Tiantan Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isosorbide Mononitrate and Butylphthalide in people with Stroke, Lacunar and Stroke, Acute Ischemic, run by Beijing Tiantan 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 11 inclusion and 19 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 26 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 Ying Gao (+86 10 59976165, tjssgaoying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with post-stroke disability at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.