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

Mahidol University

Status and phase: Enrolling; Phase 4

Conditions: Intravenous; Thrombosis; Acute Ischemic Stroke

Treatments: Drug: tenecteplase

Study type: Interventional

Funder types: Other

Identifiers

NCT06498323

376/2565(IRB1)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

tenecteplase

Experimental group

Description:

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.

Treatment:

Drug: tenecteplase

alteplase

Active Comparator group

Description:

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.

Treatment:

Drug: tenecteplase