ASP II (Ancrod Stroke Program) Study of Acute Viprinex™ for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 311
- 试验地点
- 92
- 主要终点
- Modified Rankin Score - responder analysis
研究概览
简要总结
The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.
详细描述
With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- •Baseline NIHSS > 5
排除标准
- •No intracranial, extravascular blood on CT
- •Hypertension (systolic > 185; diastolic > 105)
- •Baseline fibrinogen level < 100 mg/dL
- •Thrombocytopenia (< 100,000 / mm3)
- •Recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent
- •Recent (< 14 days) or anticipated surgery
研究组 & 干预措施
Intravenous ancrod
Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.
干预措施: Ancrod (Viprinex) (Biological)
Intravenous Placebo
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Score - responder analysis
时间窗: 90 days
次要结局
- Barthel Index, NIHSS(90 days)