Overview
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.
Eligibility
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.
