RecruitingPhase 4NCT06498323

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

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


Sponsor

Mahidol University

Enrollment

160 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This multi-center trial compares two clot-busting drugs — tenecteplase and alteplase — for treating acute ischemic stroke when administered on mobile stroke units, which bring hospital-level care to patients before they arrive at the emergency room. Tenecteplase is easier to administer (single injection instead of an infusion) and may improve blood flow to the brain more quickly. Adults over 18 who have had a stroke within the last 4.5 hours and have no contraindications to clot-dissolving treatment are eligible. Participation involves receiving one of the two drugs on the mobile stroke unit, followed by standard hospital care and neurological outcome assessments over 90 days. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtenecteplase

Intravenous thrombolytic agents administration


Locations(1)

Siriraj Stroke Center,Siriraj Hospital

Bangkok, Thailand

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NCT06498323


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