Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- General Hospital of Shenyang Military Region
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
概览
简要总结
Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion.
This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.
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 year;
- •Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
- •Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
- •No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
- •The second intravenous thrombolysis can be administered within 4.5 hours of onset;
- •First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- •Signed informed consent.
排除标准
- •Planed for endovascular treatment;
- •Significant cerebral white matter hyperintensities (Fazekas score 3)；
- •Any coagulation abnormality before the first thrombolysis, including INR \> 1.5；
- •Pregnancy；
- •Allergy to the investigational drug(s)；
- •Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;
- •Comorbidity with other serious diseases;
- •Participating in other clinical trials within 3 months;
- •Patients not suitable for the study considered by researcher.
研究组 & 干预措施
TNK group
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
干预措施: Tenecteplase (Drug)
Control group
No tenecteplase
结局指标
主要结局
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
时间窗: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
次要结局
- proportion of modified Rankin Scale (mRS) 0-2(90±7 days)
- ordinal distribution of modified Rankin Scale (mRS)(90±7 days)
- occurrence of early neurological improvement (ENI)(24 (-6/+12) hours)
- change in National Institute of Health stroke scale (NIHSS) score(24 (-6/+12) hours)
- change in National Institute of Health stroke scale (NIHSS) score(10±2 days)
- new stroke or other vascular event(s)(90±7 days)
- symptomatic intracranial hemorrhage (sICH)(24 (-6/+12) hours)
- any intracranial hemorrhage(24 (-6/+12) hours)
- major systemic bleeding event(24 (-6/+12) hours)
- any bleeding event(24 (-6/+12) hours)
- all-cause mortality(90±7 days)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region