Clinical trial NCT06498323: Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT
Official title: Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intravenous
Thrombosis
Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Mobile stroke unit
Intravenous Tenecteplase
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset
* Have contraindication for thrombolytic drugs

Primary outcomes:
measure: mRS Score
timeFrame: at 3 months
Secondary outcomes:
measure: NIHSS Score at 24 hrs
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Stroke Center,Siriraj Hospital
Study officials:
References:
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