Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)
Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study
General Hospital of Shenyang Military Region
120 participants
Mar 25, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria9
- 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.
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Interventions
Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07375953