NCT06498323 Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT
| NCT ID | NCT06498323 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mahidol University |
| Condition | Intravenous |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-08-03 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2022-08-03 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06498323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intravenous. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06498323 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06498323 currently recruiting?
Yes, NCT06498323 is actively recruiting participants. Contact the research team at ynilanon@gmail.com for enrollment information.
Where is the NCT06498323 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06498323 clinical trial?
NCT06498323 is sponsored by Mahidol University. The trial plans to enroll 160 participants.