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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
794
a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
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)
Time frame: 90 days after procedure
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
Time frame: 90 days after procedure
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)
Time frame: 90 days after procedure
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).
Time frame: 24 hours after randomization
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.
Time frame: Baseline and 7-days after randomization (or at discharge)
Symptomatic intracranial hemorrhage (SICH) as defined by the Heidelberg Bleeding Classification
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death.
Time frame: within 36 hours after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.