EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- symptomatic intracerebral hemorrhage
研究概览
简要总结
To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.
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
- Single (Outcomes Assessor)
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
- •age: 18-80;
- •ischemic stroke confirmed by brain CT or MRI
- •the time from onset to treatment: 4.5-6 hours
- •prestroke mRS≤1
- •signed informed consent
排除标准
- •prestroke mRS≥2
- •planned endovascular treatment
- •planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion
- •any contraindiction of intravenous thrombolysis
- •other unsuitable conditions judged by investigator
研究组 & 干预措施
TNK group
intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg
干预措施: TNK-Tissue Plasminogen Activator (Drug)
control group
干预措施: TNK-Tissue Plasminogen Activator (Drug)
结局指标
主要结局
symptomatic intracerebral hemorrhage
时间窗: 36 hours
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
次要结局
- The proportion of excellent prognosis (mRS 0-1)(Day 90)
- The proportion of favourable prognosis (mRS 0-2)(Day 90)
- Distribution of modified Rankin Score(Day 90)
- Changes in National Institute of Health stroke scale (NIHSS)(24 hours, 2 weeks)
- any intracerebral hemorrhage(36 hours)
- any cerebral microbleeding(CMB)(48 hours)
- infarct volume(48 hours)
- proportion of death(Day 90)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region