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NCT Number: NCT07283159

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

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 confirmed by neuroimaging;
  • The time from last known well to treatment is within 4.5 hours;
  • NIHSS ≥ 6 at randomization;
  • Received intravenous tenecteplase (0.25mg/kg);
  • First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
  • Signed informed consent.

Exclusion criteria

  • Planed for endovascular treatment;
  • Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
  • Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
  • Pregnancy；
  • Allergy to the investigational drug(s)；
  • 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

Human Urinary Kallidinogenase

Drug

Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.

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

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

    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: 10±2 days

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

  5. 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

  6. new stroke or other vascular event(s)

    Time frame: 90±7 days

  7. symptomatic intracranial hemorrhage (sICH)

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

    sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration (≥4-point increase in NIHSS score).

  8. major systemic bleeding events

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

    Bleeding leading to a decrease in hemoglobin ≥ 2 g/dL or transfusion of ≥ 2 units of blood.

  9. any bleeding events

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

    Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage.

  10. any intracranial hemorrhage

    Time frame: 10±2 days

    Heidelberg Bleeding Classification

  11. all-cause mortality

    Time frame: 90±7 days

    death from any cause

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Jan 23, 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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