Butylphthalide for Brain Edema After Endovascular Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Butylphthalide
  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.
• Препарат Placebo
  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.

Первичные конечные точки

• Delta cerebrospinal fluid [Срок оценки: 72hours after the stroke onset]

Вторичные конечные точки (11)

• Symptomatic intracranial hemorrhage [Срок оценки: 72hours after the stroke onset]
• NWU [Срок оценки: 72hours after the stroke onset]
• CED grade [Срок оценки: 72hours after the stroke onset]
• rHV [Срок оценки: 72hours after the stroke onset]
• Malignant cerebral edema [Срок оценки: 48 to 96 hours after onset]
• Midline shift distance [Срок оценки: 72 to 96 hours after onset]
• Early neurological deterioration [Срок оценки: Within 7 days post-treatment]
• Decompressive craniectomy [Срок оценки: Within 7 days post-treatment]
• Infarct volume [Срок оценки: 48-96hours after the stroke onset]
• Modified Rankin Scale of 0 to 2 points [Срок оценки: 90 days after the stroke onset]
• Distribution of modified Rankin Scale (mRS) scores [Срок оценки: 90 days after the stroke onset]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• Dongguan People's Hospital — Дунгуань
• Nanfang Hospital of Southern Medical University — Гуанчжоу
• The Fourth Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Heyuan People's Hospital — Heyuan
• Qingyuan People's Hospital — Qingyuan
• Yuebei People's Hospital — Shaoguan
• Haikou People's Hospital — Haikou
• Hainan Provincial Hospital of Traditional Chinese Medicine — Haikou
• … и ещё 2 центра

Идентификаторы

NCT: NCT07528456 · NFEC-2026-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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