NCT07375953RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 25 Mar 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT07375953
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 25 Mar 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Allergy to the investigational drug(s)；
- Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;
Other illness
- Comorbidity with other serious diseases;
Lab values
- Any coagulation abnormality before the first thrombolysis, including INR \> 1.5；
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yu Cui Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.