Acute Ischemic StrokePhase 4NCT07528456
Butylphthalide for Brain Edema After Endovascular Treatment
A Phase 4 study testing Butylphthalide in people with Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 10 sites in China.
Trial summary
This is a prospective, multicenter, randomized controlled clinical study aimed at evaluating the efficacy of butylphthalide in improving the severity of cerebral edema and prognosis in patients with acute anterior circulation large vessel occlusion after endovascular treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Butylphthalide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesChina
- Study dates
- 1 Apr 2026to Dec 2027
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Time from onset to randomization within 24 hours.
- Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA).
- NIHSS score ≥10 at onset, or NIHSS score >8 at 1 hour post-procedure (for those able to cooperate with NIHSS assessment), or CT-ASPECTS score 3-7 immediately post-procedure.
- Received endovascular treatment with successful reperfusion (mTICI ≥2b).
- Signed informed consent form by the subject or their legally authorized representative.
Who cannot join
- Pre-stroke modified Rankin Scale (mRS) score ≥2.
- Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage.
- Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy.
- History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor.
- Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis.
- Clinical or radiological evidence of vertebral or basilar artery occlusion.
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- History of severe renal impairment (e.g., on dialysis) or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²; severe hepatic disease or alanine aminotransferase (ALT) >3× the upper limit of normal, or total bilirubin >2× the upper limit of normal.
- Use of butylphthalide within 7 days prior to enrollment.
- Known allergy to butylphthalide.
- Pregnancy.
- Breastfeeding women who do not agree (or whose legally authorized representative does not allow) to discontinue breastfeeding during the study drug administration period and for 7 days thereafter.
- Participation in other purely observational stroke studies, or expected survival <6 months unrelated to the current stroke, or unlikely to comply with follow-up requirements.
- Currently receiving another investigational drug with the same or similar mechanism of action as the study drug.
- Any condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Dongguan People's Hospital
Dongguan, Guangdong
Yangkun Chen
Ganzhou People's Hospital
Ganzhou, Jiangxi
Xianghong Liu
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Suyue Pan, +86 0206278764, pansuyue@smu.edu.cn
The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Jianbin Zhong
Haikou People's Hospital
Haikou, Hainan
Guoshuai Yang
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan
Guohu Weng
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Heyuan People's Hospital
Heyuan, Guangdong
Zhenqin Jiang
Qingyuan People's Hospital
Qingyuan, Guangdong
Xianglin Chen
Yuebei People's Hospital
Shaoguan, Guangdong
Junbin Chen
About this study
Official title: Efficacy and Safety of Butylphthalide in Improving Cerebral Edema After Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial
This is a prospective, multicenter, randomized controlled clinical study aimed at evaluating the efficacy of butylphthalide in improving the severity of cerebral edema and prognosis in patients with acute anterior circulation large vessel occlusion after endovascular treatment.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Butylphthalide, Placebo
- Keywords
- Acute Ischemic Stroke, Endovascular therapy, Butylphthalide, Cerebral edema, Prognosis
- Medical subject headings
- Ischemic Stroke, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButylphthalideDrug
For patients in the butylphthalide group, Butylphthalide and Sodium Chloride Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14.
PlaceboDrug
For patients in the placebo group, Placebo Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14.
| Study group | Role | What they receive |
|---|---|---|
| Butylphthalide | Experimental | Not described Receives: Drug: Butylphthalide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta cerebrospinal fluid
Change from baseline in cerebrospinal fluid
Measured: 72hours after the stroke onset
Secondary outcomes (11)
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.
Measured: 72hours after the stroke onset
NWU
Net water uptake assessed by CT
Measured: 72hours after the stroke onset
CED grade
Cerebral edema grade assessed by CT
Measured: 72hours after the stroke onset
rHV
Relative hemispheric volume ratio assessed by CT
Measured: 72hours after the stroke onset
Malignant cerebral edema
Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns.
Measured: 48 to 96 hours after onset
Midline shift distance
Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.
Measured: 72 to 96 hours after onset
Early neurological deterioration
Defined as an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, with higher scores indicating worse outcome) within 7 days post-treatment.
Measured: Within 7 days post-treatment
Decompressive craniectomy
The subject underwent decompressive craniectomy due to clinical necessity.
Measured: Within 7 days post-treatment
Infarct volume
Infarct volume assessed by computed tomography (CT) or magnetic resonance imaging (MR)
Measured: 48-96hours after the stroke onset
Modified Rankin Scale of 0 to 2 points
Modified Rankin Scale (mRS; range 0-6, with higher scores indicating worse outcome) score of 0 to 2 points.
Measured: 90 days after the stroke onset
Distribution of modified Rankin Scale (mRS) scores
Shift analysis of mRS scores at 90 days (range 0-6).
Measured: 90 days after the stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
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 Nanfang Hospital, Southern Medical 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528456
- Sponsor's protocol ID
- NFEC-2026-105
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Butylphthalide in Improving Cerebral Edema After Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07528456
- Acronym / sponsor ID
- NFEC-2026-105
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Endovascular therapy, Butylphthalide, Cerebral edema, Prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (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 is a prospective, multicenter, randomized controlled clinical study aimed at evaluating the efficacy of butylphthalide in improving the severity of cerebral edema and prognosis in patients with acute anterior circulation large vessel occlusion after endovascular treatment.
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: Butylphthalide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Time from onset to randomization within 24 hours.
- Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA).
- NIHSS score ≥10 at onset, or NIHSS score >8 at 1 hour post-procedure (for those able to cooperate with NIHSS assessment), or CT-ASPECTS score 3-7 immediately post-procedure.
- Received endovascular treatment with successful reperfusion (mTICI ≥2b).
Key exclusion criteria (14 listed)
- Pre-stroke modified Rankin Scale (mRS) score ≥2.
- Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage.
- Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy.
- History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor.
- Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis.
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 |
|---|---|---|
| ButylphthalideFor patients in the butylphthalide group, Butylphthalide and Sodium Chloride Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14. | Drug | Butylphthalide |
| PlaceboFor patients in the placebo group, Placebo Injection was administered immediately after randomization, 100 ml per dose, intravenously, twice daily, for at least 7 days, continuing until discharge or day 14. | Drug | Placebo |
Primary outcome
Delta cerebrospinal fluid
Time frame: 72hours after the stroke onset
Change from baseline in cerebrospinal fluid
11 secondary outcomes
Symptomatic intracranial hemorrhage
Time frame: 72hours after the stroke onset
NWU
Time frame: 72hours after the stroke onset
CED grade
Time frame: 72hours after the stroke onset
rHV
Time frame: 72hours after the stroke onset
Malignant cerebral edema
Time frame: 48 to 96 hours after onset
Midline shift distance
Time frame: 72 to 96 hours after onset
Early neurological deterioration
Time frame: Within 7 days post-treatment
Decompressive craniectomy
Time frame: Within 7 days post-treatment
Infarct volume
Time frame: 48-96hours after the stroke onset
Modified Rankin Scale of 0 to 2 points
Time frame: 90 days after the stroke onset
Distribution of modified Rankin Scale (mRS) scores
Time frame: 90 days after the stroke onset
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 14 Apr 2026.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Butylphthalide in people with Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 10 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 14 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Kaibin Huang, PhD (+86 15915751065, hkb@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta cerebrospinal fluid (time frame: 72hours after the stroke onset). 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 14 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.