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.
Age 18 years or greater
Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke).
Prestroke mRS 0-2
NIHSS 6 to 25
Current or past history of significant bleeding over the past 6 months;
History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage;
Known bleeding tendency;
Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease;
Parallel
TNK
Druga dose of 0.25 mg/kg (max 25 mg) administered as a bolus
Standard medical treatment
Drugantiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Proportion of patients with functional independence outcome (mRS 0-2) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
The ordinal shift of modified Rankin Scale
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Proportion of patients with functional independence outcome (mRS 0-1) at day 90
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Recanalization of occlusion site according to the arterial occlusive lesion (AOL) scale
It specifically measures the mechanical success of recanalization at the site of the original occlusion.The scale ranges from 0 to 3, with higher scores indicating better recanalization. Grade 0: No recanalization (persistent occlusion). Grade 1: Incomplete recanalization (partial reopening with minimal flow). Grade 2: Partial recanalization (significant flow but residual stenosis or thrombus). Grade 3: Complete recanalization (full restoration of flow with no residual occlusion).
Change in Neurological Function of Participants Assessed by National Institute of Health Stroke Scale
Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.
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