A Phase 4 interventional study of tenecteplase in Intravenous, Thrombosis and Acute Ischemic Stroke, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
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.
Drug: tenecteplase
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.
Drug: tenecteplase
Intravenous thrombolytic agents administration
mRS Score
mRS Score
Time frame: at 3 months
NIHSS Score at 24 hrs
NIHSS Score at 24 hrs after intravenous tenecteplase
Time frame: at 24 hours
Plan to share: No
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Mahidol University