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Clinical Trials/NCT06498323
NCT06498323
Recruiting
Phase 4

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

Mahidol University1 site in 1 country160 target enrollmentAugust 3, 2022

Overview

Phase
Phase 4
Intervention
tenecteplase
Conditions
Intravenous
Sponsor
Mahidol University
Enrollment
160
Locations
1
Primary Endpoint
mRS Score
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2022
End Date
August 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yongchai Nilanont

associate professor

Mahidol University

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

Arms & Interventions

tenecteplase

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.

Intervention: tenecteplase

alteplase

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.

Intervention: tenecteplase

Outcomes

Primary Outcomes

mRS Score

Time Frame: at 3 months

mRS Score

Secondary Outcomes

  • NIHSS Score at 24 hrs(at 24 hours)

Study Sites (1)

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