Tenecteplase REperfusion in Acute Ischemic sTroke Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Excellent functional outcome at 90 days
研究概览
简要总结
The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.
详细描述
Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Older than 18 years;
- •Diagnosed as acute ischemic stroke；
- •Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
- •Thrombolysis with rhTNK-tPA and derivatives.
排除标准
- •Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
- •Already participated in other interventional trials.
研究组 & 干预措施
rhTNK-tPA Thrombolysis
干预措施: rhTNK-tPA Thrombolysis (Drug)
结局指标
主要结局
Excellent functional outcome at 90 days
时间窗: 3 months after thrombolysis
proportion of mRS score 0-1 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
次要结局
- Barthel(BI) at 90 days(3 months after thrombolysis)
- Neurological improvement at 24 hours(24 hours after thrombolysis)
- NIHSS score at discharge(5-7days after thrombolysis or at discharge)
- EQ-5D score at 90 days(3 months after thrombolysis)
- Ordinal distribution of mRS at 90 days(3 months after thrombolysis)
- Favorable functional outcome(3 months after thrombolysis)
- Walk independence(3 months after thrombolysis)
研究者
Yunyun Xiong
Professor of Neurology and Stroke Center
Beijing Tiantan Hospital