Actively Recruiting
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
Eligibility Criteria
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
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
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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