Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- mRS Score
研究概览
简要总结
Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 4.5 hours and without contraindications.
Tenecteplase, a genetically engineered tissue-type plasminogen activator, has been questioned to treat acute ischemic stroke instead of intravenous alteplase. Tenecteplase has more advantages over alteplase including higher fibrin specificity, longer half-life and easier to administer as a single intravenous bolus. The efficacy and safety of intravenous tenecteplase has been studied recently. In 2017, A phase 3 randomized open-label, blinded trial (NOR-TEST) 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients. A study in 2020, in the setting of acute large artery occlusion, Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10. Regarding safety concerns, tenecteplase showed no significant higher incidence of intracerebral hemorrhage. Administration, tenecteplase might be better in the setting of the case on mobile stroke units. Assuming, earlier reperfusion by thrombolytic drug may have improved patient's neurologic outcomes. We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 4.5 hours after symptom onset.
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 (Participant)
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
- •Diagnosed as Acute ischemic stroke within 4.5 hr of symptom onset
- •Age > 18 years old
- •No contraindication for thrombolytic drug
- •Informed consent from patients
排除标准
- •Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset
- •Have contraindication for thrombolytic drugs
研究组 & 干预措施
tenecteplase
Intravenous tenecteplase (0.25mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.
干预措施: tenecteplase (Drug)
alteplase
Intravenous alteplase (0.9mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.
干预措施: tenecteplase (Drug)
结局指标
主要结局
mRS Score
时间窗: at 3 months
mRS Score
次要结局
- NIHSS Score at 24 hrs(at 24 hours)
研究者
Yongchai Nilanont
associate professor
Mahidol University
