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临床试验/NCT00343174
NCT00343174已完成3 期

Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT

Heidelberg University0 个研究点开始时间: 2006年6月22日最近更新:
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试验速览

阶段
3 期
状态
已完成

研究概览

简要总结

Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( < 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

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

  • •18 years and above, both sexes
  • •Acute ischemic stroke with first symptoms within 6 hours of beginning
  • •Treatment after onset of symptoms
  • •SSS < 40 at baseline ( consciousness necessary )

排除标准

  • •Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation
  • •CT evidence of major signs of developing infarction
  • •Prior strokes within 6 weeks
  • •Severe hypertension (> 220 systolic > 120 mm Hg diastolic)
  • •Baseline fibrinogen < 100 mg/dL
  • •Recent use of thrombolytic agents
  • •Recent or anticipated surgery

研究者

申办方类型
Other

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