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Not yet recruitingNCT07528456Updated Apr 14, 2026

Butylphthalide for Brain Edema After Endovascular Treatment

A Phase 4 interventional study of Butylphthalide and Placebo in Acute Ischemic Stroke, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Acute Ischemic Stroke
  • Endovascular therapy
  • Butylphthalide
  • Cerebral edema
  • Prognosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years.
  2. Time from onset to randomization within 24 hours.
  3. Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA).
  4. 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.
  5. Received endovascular treatment with successful reperfusion (mTICI ≥2b).
  6. Signed informed consent form by the subject or their legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  1. Pre-stroke modified Rankin Scale (mRS) score ≥2.
  2. Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage.
  3. Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy.
  4. History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor.
  5. Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis.
  6. Clinical or radiological evidence of vertebral or basilar artery occlusion.
  7. 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.
  8. Use of butylphthalide within 7 days prior to enrollment.
  9. Known allergy to butylphthalide.
  10. Pregnancy.
  11. 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.
  12. 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.
  13. Currently receiving another investigational drug with the same or similar mechanism of action as the study drug.
  14. Any condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Butylphthalide

    Drug: Butylphthalide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugButylphthalide

    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.

  • DrugPlacebo

    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.

05

What researchers measure

Primary outcomes

  1. Delta cerebrospinal fluid

    Change from baseline in cerebrospinal fluid

    Time frame: 72hours after the stroke onset

Secondary outcomes

  1. Symptomatic intracranial hemorrhage

    Symptomatic intracranial hemorrhage associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.

    Time frame: 72hours after the stroke onset

  2. NWU

    Net water uptake assessed by CT

    Time frame: 72hours after the stroke onset

  3. CED grade

    Cerebral edema grade assessed by CT

    Time frame: 72hours after the stroke onset

  4. rHV

    Relative hemispheric volume ratio assessed by CT

    Time frame: 72hours after the stroke onset

  5. 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.

    Time frame: 48 to 96 hours after onset

  6. Midline shift distance

    Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.

    Time frame: 72 to 96 hours after onset

  7. 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.

    Time frame: Within 7 days post-treatment

  8. Decompressive craniectomy

    The subject underwent decompressive craniectomy due to clinical necessity.

    Time frame: Within 7 days post-treatment

  9. Infarct volume

    Infarct volume assessed by computed tomography (CT) or magnetic resonance imaging (MR)

    Time frame: 48-96hours after the stroke onset

  10. 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.

    Time frame: 90 days after the stroke onset

  11. Distribution of modified Rankin Scale (mRS) scores

    Shift analysis of mRS scores at 90 days (range 0-6).

    Time frame: 90 days after the stroke onset

06

Study locations

10 sites
  • Dongguan People's Hospital
    Dongguan, Guangdong, China
    • Yangkun Chen · Contact
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong 510515, China
  • The Fourth Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
    • Jianbin Zhong · Contact
  • Heyuan People's Hospital
    Heyuan, Guangdong, China
    • Zhenqin Jiang · Contact
  • Qingyuan People's Hospital
    Qingyuan, Guangdong, China
    • Xianglin Chen · Contact
  • Yuebei People's Hospital
    Shaoguan, Guangdong, China
    • Junbin Chen · Contact
  • Haikou People's Hospital
    Haikou, Hainan, China
    • Guoshuai Yang · Contact
  • Hainan Provincial Hospital of Traditional Chinese Medicine
    Haikou, Hainan, China
    • Guohu Weng · Contact
  • The Second Affiliated Hospital of Hainan Medical University
    Haikou, Hainan, China
  • Ganzhou People's Hospital
    Ganzhou, Jiangxi, China
    • Xianghong Liu · Contact
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07528456
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 14, 2026

Study contacts

Kaibin Huang, PhD
Contact
hkb@smu.edu.cn
+86 15915751065
Suyue Pan, PhD
Contact
pansuyue@smu.edu.cn
+86 02062787648

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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