NCT02164357已完成不适用
Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal5 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 5
- 主要终点
- Death within 90 days after onset
研究概览
简要总结
This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •80 or less years old patients with acute stroke produced by a main artery occlusion
- •NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)
- •Patients receiving EVT or IVT within 4.5 hours after onset
排除标准
- •EVT or IVT contraindication
- •Previous neurological impairment, severe concomitant disease or poor prognosis.
- •Pregnancy or breastfeeding
- •Known hypersensitivity to any study drugs
- •Severe organic disease for which there is not risk compensation.
结局指标
主要结局
Death within 90 days after onset
时间窗: 90 days
Symptomatic intracranial haemorrhage
时间窗: 7 days
次要结局
- Stroke recovery rate after discharge(From onset to discharge)
- Functional recovery(4.5 hours after onset)
研究者
研究点 (5)
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