NCT07375953 Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)
| NCT ID | NCT07375953 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | General Hospital of Shenyang Military Region |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-03-25 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07375953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07375953 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07375953 currently recruiting?
Yes, NCT07375953 is actively recruiting participants. Visit ClinicalTrials.gov or contact General Hospital of Shenyang Military Region to inquire about joining.
Where is the NCT07375953 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07375953 clinical trial?
NCT07375953 is sponsored by General Hospital of Shenyang Military Region. The trial plans to enroll 120 participants.
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