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临床试验/NCT06498323
NCT06498323招募中4 期

Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年8月3日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongchai Nilanont

associate professor

Mahidol University

研究点 (1)

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