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NCT Number: NCT07375953

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenecteplase

Drug

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

Primary outcomes

  1. proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary outcomes

  1. proportion of modified Rankin Scale (mRS) 0-2

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  2. ordinal distribution of modified Rankin Scale (mRS)

    Time frame: 90±7 days

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  3. occurrence of early neurological improvement (ENI)

    Time frame: 24 (-6/+12) hours

    ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score (NIHSS); the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

  4. change in National Institute of Health stroke scale (NIHSS) score

    Time frame: 24 (-6/+12) hours

    the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome

  5. change in National Institute of Health stroke scale (NIHSS) score

    Time frame: 10±2 days

    the minimum and maximum values of National Institute of Health stroke scale (NIHSS) are 0 and 42, respectively; higher NIHSS score mean a worse outcome

  6. new stroke or other vascular event(s)

    Time frame: 90±7 days

  7. symptomatic intracranial hemorrhage (sICH)

    Time frame: 24 (-6/+12) hours

  8. any intracranial hemorrhage

    Time frame: 24 (-6/+12) hours

  9. major systemic bleeding event

    Time frame: 24 (-6/+12) hours

  10. any bleeding event

    Time frame: 24 (-6/+12) hours

  11. all-cause mortality

    Time frame: 90±7 days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Acronym: RITIS-TNK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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