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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Begins enrollment this month; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Tenecteplase

Study type: Interventional

Funder types: Other

Identifiers

NCT07375953

Y (2025) 501

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

TNK group

Experimental group

Description:

Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.

Treatment:

Drug: Tenecteplase

Control group

No Intervention group

Description:

No tenecteplase