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
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
