Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion.
This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.
Age ≥ 18 year;
Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
Planed for endovascular treatment;
Significant cerebral white matter hyperintensities (Fazekas score 3)；
Any coagulation abnormality before the first thrombolysis, including INR > 1.5；
Pregnancy；
Parallel
Tenecteplase
DrugTenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
proportion of modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score (NIHSS); the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome
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