NCT07528456尚未招募4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Delta cerebrospinal fluid
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pre-stroke modified Rankin Scale (mRS) score ≥
- •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.
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Butylphthalide
Experimental
干预措施: Butylphthalide (Drug)
结局指标
主要结局
Delta cerebrospinal fluid
时间窗: 72hours after the stroke onset
Change from baseline in cerebrospinal fluid
次要结局
- rHV(72hours after the stroke onset)
- Symptomatic intracranial hemorrhage(72hours after the stroke onset)
- NWU(72hours after the stroke onset)
- CED grade(72hours after the stroke onset)
- Malignant cerebral edema(48 to 96 hours after onset)
- Midline shift distance(72 to 96 hours after onset)
- Early neurological deterioration(Within 7 days post-treatment)
- Decompressive craniectomy(Within 7 days post-treatment)
- Infarct volume(48-96hours after the stroke onset)
- Modified Rankin Scale of 0 to 2 points(90 days after the stroke onset)
- Distribution of modified Rankin Scale (mRS) scores(90 days after the stroke onset)
研究者
研究点 (10)
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