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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
Yu Cui
Shenyang, None Selected, China
RECRUITINGproportion 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
Time frame: 90±7 days
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
Time frame: 90±7 days
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
Time frame: 90±7 days
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
Time frame: 24 (-6/+12) hours
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
Time frame: 24 (-6/+12) hours
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
Time frame: 10±2 days
new stroke or other vascular event(s)
Time frame: 90±7 days
symptomatic intracranial hemorrhage (sICH)
Time frame: 24 (-6/+12) hours
any intracranial hemorrhage
Time frame: 24 (-6/+12) hours
major systemic bleeding event
Time frame: 24 (-6/+12) hours
any bleeding event
Time frame: 24 (-6/+12) hours
all-cause mortality
Time frame: 90±7 days
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