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Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Summary
The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.
Official title: Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
794
Start Date
2025-11-01
Completion Date
2028-05-31
Last Updated
2025-09-11
Healthy Volunteers
No
Interventions
TNK
a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
Standard medical treatment
antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Locations (1)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China