Clinical Trial

Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT

Study acronym: TNK LATE
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07168278
Lead Sponsor The First Affiliated Hospital of University of Science and Technology of China
Conditions Acute Ischemic Stroke, Large Vessel Occlusion, Tenecteplase, Thrombolysis
Enrollment 794 participants
Start Date 2025-11-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-11