Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 808
- 主要终点
- The proportion of modified Rankin Scale responders at 3 months in the primary population.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.
详细描述
Abciximab is a drug that prevents platelets from sticking together and forming a clot. There are limited studies using abciximab in the treatment of strokes. This phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study is designed to assess the effectiveness and safety of abciximab for treatment of acute ischemic stroke, in helping dissolve clots in brain arteries so that blood and oxygen can flow better and there may be less brain damage.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either Abciximab: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 µg/kg/min infusion (to a maximum of 10 µg/min) for 12 hours or a bolus of placebo followed by infusion for 12 hours
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
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
- •Patients with diagnosis of acute ischemic stroke with onset within 5 hours and 30 minutes before randomization and planned treatment initiation within 6 hours of onset
- •After 600 patients are enrolled in previous criteria, the new criteria for enrollment will be, patients with diagnosis of acute ischemic stroke with onset within 4 hours and 30 minutes before randomization and planned treatment initiation within 5 hours of onset
排除标准
- •Patients who had participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial
- •Patients with symptoms suggestive of subarachnoid hemorrhage
- •Female patients known to be pregnant, lactating, or having a positive or indeterminate pregnancy test
- •Patients with neurological deficit that has led to stupor or coma
- •Patients with minor stroke
结局指标
主要结局
The proportion of modified Rankin Scale responders at 3 months in the primary population.
次要结局
- Proportion of patients with neurological recovery and all-cause mortality at 3 months in the primary population. Fatal intracranial-, nonfatal symptomatic parenchymal-, or other symptomatic intracranial hemorrhages though discharge at day 5 & 3 months