Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT

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.

NCT Number	NCT06498323
Lead Sponsor	Mahidol University
Conditions	Intravenous, Thrombosis, Acute Ischemic Stroke
Enrollment	160 participants
Start Date	2022-08-03
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-08-31 (estimated)
Updated on ClinicalTrials.gov	2024-07-12