NCT06211712招募中不适用
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- ASPECT score evaluated using routine CT
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.
详细描述
A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.
Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:
- Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
- Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.
The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.
End of study evaluation will occur at day 90±7 or premature discontinuation.
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
- Double (Participant, Investigator)
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
- •Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
- •Age ≥18 years old.
- •The mRS score was 0-1 before onset.
- •ASPECT score of infarction on emergency CT ≥
- •Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
- •Emergency CTP or DWI suggesting infarct core body ≥10 mL and <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.
- •Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).
排除标准
- •Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
- •CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
- •Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
- •Taking ACEI antihypertensive drugs regularly and could not stop.
- •Participant with major surgery or severe trauma in the past 2 weeks.
- •Poor compliance and cannot fully follow the study protocol.
- •Pregnancy or lactation.
结局指标
主要结局
ASPECT score evaluated using routine CT
时间窗: on day 7 after EVT
Modified Rankin Scale (mRS) score
时间窗: on day 90 after EVT
次要结局
- Changes of vital signs from baseline(day 1, 4, 7 and 10 after EVT)
- Barthel index(on day 10 and 90 after EVT)
- Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT(day 7 after EVT)
- Changes of NIH Stroke Scale(NIHSS) score from baseline(day 1, 4, 7 and 10 after EVT)
- Percentage of TIC ≥ 2b and mRS ≤2(on day 90 after EVT)
- MRI and / or DWI examined(within 10 days to determine the infarct volume)
- Recurrence rate of ischemic stroke(within 90 days after EVT)
研究者
Qiang Dong
Chief physician
Huashan Hospital
研究点 (2)
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