Ischemic Stroke
Conditions
Brief summary
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.
Interventions
DRUGTenecteplase
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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; * The second intravenous thrombolysis can be administered within 4.5 hours of onset; * First stroke onset or past stroke without obvious neurological deficit (mRS≤1); * Signed informed consent.
Exclusion criteria
* Planed for endovascular treatment; * Significant cerebral white matter hyperintensities (Fazekas score 3)； * Any coagulation abnormality before the first thrombolysis, including INR \> 1.5； * Pregnancy； * Allergy to the investigational drug(s)； * Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis; * Comorbidity with other serious diseases; * Participating in other clinical trials within 3 months; * Patients not suitable for the study considered by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of modified Rankin Scale (mRS) 0-2 | 90±7 days | 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) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| occurrence of early neurological improvement (ENI) | 24 (-6/+12) hours | 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 | 24 (-6/+12) hours | 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 |
| new stroke or other vascular event(s) | 90±7 days | — |
| symptomatic intracranial hemorrhage (sICH) | 24 (-6/+12) hours | — |
| any intracranial hemorrhage | 24 (-6/+12) hours | — |
| major systemic bleeding event | 24 (-6/+12) hours | — |
| any bleeding event | 24 (-6/+12) hours | — |
| all-cause mortality | 90±7 days | — |
Countries
China
Outcome results
None listed