Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 22
- 主要终点
- Cerebral Infarct Volume on Day 8
研究概览
简要总结
This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.
详细描述
Eligible participants will be randomly assigned to receive anisodine hydrobromide or matching placebo in addition to standard care, with efficacy and safety assessed during follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Anterior-circulation large-vessel occlusion involving the intracranial ICA, M1, or proximal/dominant M2
- •Eligible for endovascular treatment within 24 hours of last known well
- •Baseline NIHSS score ≥6
- •Baseline ASPECTS ≥6
- •Pre-stroke mRS score 0-1
- •Written informed consent provided by the participant or legally authorized representative
排除标准
- •Intracranial hemorrhage on baseline imaging
- •Significant bleeding disorder or coagulopathy
- •Vascular anatomy unsuitable for EVT
- •Pregnancy, breastfeeding, or planned pregnancy within 90 days
- •Known hypersensitivity or severe intolerance to anisodine hydrobromide
- •Contraindication to anticholinergic drugs
- •Severe arrhythmia or hemodynamic instability
- •Severe psychiatric disorder, dementia, or impaired consciousness precluding consent or follow-up
- •Malignancy or other severe systemic disease with a life expectancy <90 days
- •Participation in another clinical trial within 30 days before enrollment or concurrently
- •Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation
研究组 & 干预措施
Anisodine Hydrobromide Group
Participants will receive anisodine hydrobromide combined with endovascular thrombectomy.
干预措施: Anisodine Hydrobromide (Drug)
Anisodine Hydrobromide placebo
Participants will receive placebo combined with endovascular thrombectomy.
干预措施: Anisodine Hydrobromide Placebo (Drug)
结局指标
主要结局
Cerebral Infarct Volume on Day 8
时间窗: Day 8
次要结局
- NIHSS Score at 24 Hours(24 hours)
- NIHSS Score on Day 8(Day 8)
- Change in NIHSS Score From Baseline to Day 8(Baseline to Day 8)
- mRS Score of 0-1 at 90 Days(90 Days)
- mRS Score of 0-2 at 90 Days(90 Days)
- Distribution of mRS scores at 90 Days(90 Days)
- EQ-5D-5L at 90 Days(90 Days)
- Barthel Index Score of 95-100 at 90 Days(90 Days)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University