Repeated IV tenecteplase for ischemic stroke within 3 hours of onset

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

This test tries a second IV dose of tenecteplase in adults with acute ischemic stroke who do not improve one hour after the first dose to see if a repeat dose is safe and can help reopen the blocked vessel.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang, None Selected)
• Trial ID: NCT07375953 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls adults with acute ischemic stroke who received standard IV tenecteplase within 3.0 hours of onset and have NIHSS ≥4 but show no significant improvement one hour after treatment with intracranial hemorrhage excluded. Eligible participants who remain eligible can receive a second IV tenecteplase dose within 4.5 hours of onset as a rescue therapy. The primary objective is to test the safety and feasibility of this repeated thrombolysis approach, and secondary analyses will explore early recanalization rates and longer-term functional outcomes. Patients planned for endovascular therapy or with major bleeding risk or significant white-matter disease are excluded.

Who should consider this trial

Good fit: Adults (≥18) with acute ischemic stroke who received standard IV tenecteplase within 3 hours, have NIHSS ≥4, show ≤2-point NIHSS improvement at 1 hour with no intracranial hemorrhage, and can receive a second dose within 4.5 hours are ideal candidates.

Not a fit: Patients planned for endovascular treatment, with coagulation abnormalities, pregnancy, heavy white-matter disease (Fazekas 3), recent dual antiplatelet use, or other major comorbidities are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If safe and effective, a second tenecteplase dose could increase early vessel reopening and reduce disability after acute ischemic stroke.

How similar studies have performed: Tenecteplase has performed well compared with alteplase in some prior trials, but repeat IV thrombolysis as a rescue strategy is a novel approach with only limited supporting data to date.

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.

Where this trial is running

Shenyang, None Selected

• Yu Cui — Shenyang, None Selected, China (Recruiting)

Conditions Ischemic Stroke