Butylphthalide for Brain Edema After Endovascular Treatment

Ki vehet részt

• 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

Ki nem vehet részt

• 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