A second tenecteplase dose for stroke that does not improve after the first
Tests a repeat tenecteplase dose in adults whose stroke symptoms do not improve.
Plain-language title generated from the registry record
Registry title: Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)
Key facts
- Where
- Shenyang, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07375953, who can take part
Where in China
- Yu CuiShenyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- General Hospital of Shenyang Military Region
- Trial code
- NCT07375953
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Allergy to the investigational drug(s)；; Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis; Comorbidity with other serious diseases; Any coagulation abnormality before the first thrombolysis, including INR > 1.5；; Planed for endovascular treatment; Significant cerebral white matter hyperintensities (Fazekas score 3)；; Pregnancy；; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.