Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06498323

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

Led by Mahidol University · Updated on 2024-07-12

160

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with acute ischemic stroke within 4.5 hours of symptom onset
  • Age over 18 years old
  • No contraindications for thrombolytic drugs
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Acute ischemic stroke with symptom onset more than 4.5 hours ago or unknown onset time
  • Contraindications for thrombolytic drugs present

AI-Screening

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Trial Site Locations

Total: 1 location

1

Siriraj Stroke Center,Siriraj Hospital

Bangkok, Thailand, 10700

Actively Recruiting

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Research Team

Y

Yongchai Nilanont

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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