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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06498323
Enrollment
160
Registered
2024-07-12
Start date
2022-08-03
Completion date
2025-08-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Intravenous, Thrombosis

Keywords

Acute ischemic stroke, Mobile stroke unit, Intravenous Tenecteplase

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.

Interventions

DRUGtenecteplase

Intravenous thrombolytic agents administration

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mRS Scoreat 3 monthsmRS Score

Secondary

MeasureTime frameDescription
NIHSS Score at 24 hrsat 24 hoursNIHSS Score at 24 hrs after intravenous tenecteplase

Countries

Thailand

Contacts

Primary ContactYongchai Nilanont
ynilanon@gmail.com924245898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026