Acute Ischemic StrokePhase 2NCT06472921
Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.
A Phase 2 study testing Butylphthalide treatment initiation time in people with Acute Ischemic Stroke, run by Xiangya Hospital of Central South University at 2 sites in China.
Trial summary
This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Butylphthalide treatment initiation time
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesChina
- Study dates
- 29 Jul 2024to 20 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years, gender not specified;
- Clinically diagnosed with acute ischemic stroke;
- Stroke onset within 3 hours;
- NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
- Pre-stroke mRS score ≤1 point;
- Participants and their representatives capable and willing to sign an informed consent form.
Who cannot join
- Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \>3 times the upper limit of normal or AST levels \>3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \>3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate [GFR] \<30 ml/min/1.73m²);
- Systolic blood pressure \<90 mmHg or \>220 mmHg;
- Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
- History of drug or food allergies, including known allergies to the components of the study medication;
- Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
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- Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
- Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
- Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
- Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
- Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
- Any other reason deemed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Xiangya Hospital, Central South University
Changsha
About this study
Official title: Effect of Early Initiation of Butylphthalide on Neural Function in Patients With Acute Ischemic Stroke -A Prospective, Multicenter, Randomized, Open-label, Blinded End Trial
This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Butylphthalide treatment initiation time
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butylphthalide treatment initiation timeBehavioural
Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group (\<3 hours) and a late initiation group (3-6 hours).
| Study group | Role | What they receive |
|---|---|---|
| Early initiation group | Experimental | Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. Receives: Behavioral: Butylphthalide treatment initiation time |
| Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml | Other | Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. Receives: Behavioral: Butylphthalide treatment initiation time |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with an mRS score of 0-2
Measured: 90±7 days post-randomization
Secondary outcomes (9)
Proportion of participants with an mRS score of 0-1
Measured: 90±7 days post-randomization
Changes in NIHSS scores
Measured: at 6±1 days and 12±2 days compared to baseline
Proportion of participants with an improvement of ≥4 points in NIHSS scores
Measured: at 6±1 days and 12±2 days
Early neurological deterioration
Measured: at 24±2 hours and 6±1 days post-randomization
Proportion of participants with ineffective recanalization
Measured: at 90±7 days post-randomization
Proportion of participants with recurrent ischemic stroke
Measured: at 90±7 days post-randomization
Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death)
Measured: at 90±7 days post-randomization
Difference in cerebral infarction volume size
Measured: between baseline and 12±2 days post-randomization
Quality of life (EQ-5D) scores
Measured: at 90±7 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start29 Jul 2024
- Primary completion1 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group and a late initiation group. Early initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. Late initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins between 3-6 hours, also administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472921
- Sponsor's protocol ID
- 202405104
- Status last verified
- Nov 2025
- First submitted
- 19 Jun 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Initiation of Butylphthalide on Neural Function in Patients With Acute Ischemic Stroke -A Prospective, Multicenter, Randomized, Open-label, Blinded End Trial
- ClinicalTrials.gov ID
- NCT06472921
- Acronym / sponsor ID
- 202405104
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 25 Jun 2024 (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 prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group and a late initiation group. Early initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. Late initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins between 3-6 hours, also administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.
| Arm | Type | Receives |
|---|---|---|
| Early initiation group | Experimental | Behavioral: Butylphthalide treatment initiation timeTreatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. |
| Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml | Other | Behavioral: Butylphthalide treatment initiation timeTreatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years, gender not specified;
- Clinically diagnosed with acute ischemic stroke;
- Stroke onset within 3 hours;
- NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
- Pre-stroke mRS score ≤1 point;
Key exclusion criteria (12 listed)
- Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \>3 times the upper limit of normal or AST levels \>3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \>3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate [GFR] \<30 ml/min/1.73m²);
- Systolic blood pressure \<90 mmHg or \>220 mmHg;
- Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
- History of drug or food allergies, including known allergies to the components of the study medication;
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 |
|---|---|---|
| Butylphthalide treatment initiation timeEligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group (\<3 hours) and a late initiation group (3-6 hours). | Behavioural | Early initiation group, Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml |
Primary outcome
The proportion of participants with an mRS score of 0-2
Time frame: 90±7 days post-randomization
9 secondary outcomes
Proportion of participants with an mRS score of 0-1
Time frame: 90±7 days post-randomization
Changes in NIHSS scores
Time frame: at 6±1 days and 12±2 days compared to baseline
Proportion of participants with an improvement of ≥4 points in NIHSS scores
Time frame: at 6±1 days and 12±2 days
Early neurological deterioration
Time frame: at 24±2 hours and 6±1 days post-randomization
Proportion of participants with ineffective recanalization
Time frame: at 90±7 days post-randomization
Proportion of participants with recurrent ischemic stroke
Time frame: at 90±7 days post-randomization
Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death)
Time frame: at 90±7 days post-randomization
Difference in cerebral infarction volume size
Time frame: between baseline and 12±2 days post-randomization
Quality of life (EQ-5D) scores
Time frame: at 90±7 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Butylphthalide treatment initiation time in people with Acute Ischemic Stroke, run by Xiangya Hospital of Central South University at 2 sites in China.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with an mRS score of 0-2 (time frame: 90±7 days post-randomization). 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 25 Nov 2025.