Butylphthalide for Brain Edema After Endovascular Treatment

NCT07528456 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NFEC-2026-105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Endovascular therapy; Butylphthalide; Cerebral edema; Prognosis

Outcome Measures

Primary Outcomes (1)

• Delta cerebrospinal fluid

  Change from baseline in cerebrospinal fluid

  72hours after the stroke onset

Secondary Outcomes (11)

• Symptomatic intracranial hemorrhage

  72hours after the stroke onset

• NWU

  72hours after the stroke onset

• CED grade

  72hours after the stroke onset

• rHV

  72hours after the stroke onset

• Malignant cerebral edema

  48 to 96 hours after onset

Study Arms (2)

Butylphthalide

EXPERIMENTAL

Drug: Butylphthalide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

Butylphthalide DRUG

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.

Butylphthalide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (10)

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Fourth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Heyuan People's Hospital

Heyuan, Guangdong, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, China

Location

Haikou People's Hospital

Haikou, Hainan, China

Location

Hainan Provincial Hospital of Traditional Chinese Medicine

Haikou, Hainan, China

Location

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Brain Edema

Interventions

3-n-butylphthalide

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kaibin Huang, PhD

CONTACT

+86 15915751065; hkb@smu.edu.cn

Suyue Pan, PhD

CONTACT

+86 02062787648; pansuyue@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)