Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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

Qualifiers

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;

Disqualifiers

Planed for endovascular treatment;

Significant cerebral white matter hyperintensities (Fazekas score 3);

Any coagulation abnormality before the first thrombolysis, including INR > 1.5;

Pregnancy;

Trial design

Treatments tested in this trial

  • Tenecteplase

Treatment groups

120 Participants
are divided into 2 treatment groups