Butylphthalide for Brain Swelling After Procedure to Open Blocked Brain Arteries in Stroke
Tests butylphthalide against placebo for brain swelling in adults after stroke treatment.
Plain-language title generated from the registry record
Registry title: Butylphthalide for Brain Edema After Endovascular Treatment
Key facts
- Where
- Dongguan, Ganzhou, Guangzhou, Haikou, Heyuan, Qingyuan, and Shaoguan, ChinaSee the 10 sites
- Phase
- Phase 4
Where in China
- Dongguan People's HospitalDongguan, ChinaNo longer taking part
- Ganzhou People's HospitalGanzhou, ChinaNo longer taking part
- Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaNo longer taking part
- The Fourth Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- Haikou People's HospitalHaikou, ChinaNo longer taking part
- Hainan Provincial Hospital of Traditional Chinese MedicineHaikou, ChinaNo longer taking part
- The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaNo longer taking part
- Heyuan People's HospitalHeyuan, ChinaNo longer taking part
- Qingyuan People's HospitalQingyuan, ChinaNo longer taking part
- Yuebei People's HospitalShaoguan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanfang Hospital, Southern Medical University
- Trial code
- NCT07528456
- Record updated
- 14 April 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis; Use of butylphthalide within 7 days prior to enrollment; 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; Currently receiving another investigational drug with the same or similar mechanism of action as the study drug; Pre-stroke modified Rankin Scale (mRS) score ≥2; Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage; History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor; Known allergy to butylphthalide; 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; Any condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study; 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; Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy; Clinical or radiological evidence of vertebral or basilar artery occlusion; Pregnancy.