Menu
Recruiting NCT07283159

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Phase II Interventional Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Human Urinary Kallidinogenase.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) [Time frame: 90±7 days]
Secondary outcome measures (11)
  • proportion of modified Rankin Scale (mRS) 0-2 [Time frame: 90±7 days]
  • ordinal distribution of modified Rankin Scale (mRS) [Time frame: 90±7 days]
  • change in National Institute of Health stroke scale (NIHSS) score [Time frame: 24 (-6/+12) hours]
  • change in National Institute of Health stroke scale (NIHSS) score [Time frame: 10±2 days]
  • occurrence of early neurological improvement (ENI) [Time frame: 24 (-6/+12) hours]
  • new stroke or other vascular event(s) [Time frame: 90±7 days]
  • symptomatic intracranial hemorrhage (sICH) [Time frame: 24 (-6/+12) hours]
  • major systemic bleeding events [Time frame: 24 (-6/+12) hours]
  • any bleeding events [Time frame: 24 (-6/+12) hours]
  • any intracranial hemorrhage [Time frame: 10±2 days]
  • all-cause mortality [Time frame: 90±7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT07283159 · Y (2025) 357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗