Tests tenecteplase with kallidinogenase for acute ischemic stroke
Tests tenecteplase with urinary kallidinogenase in adults having an acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
Key facts
- Where
- Shenyang, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a sudden stroke caused by a blocked blood vessel in the brain. They must have received tenecteplase through a vein within 4.5 hours.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke confirmed by brain imaging. Stroke severity score (NIHSS) of 6 or higher at randomization. First stroke, or an earlier stroke without clear lasting damage (mRS 1 or lower).
- Earlier treatment
- Must have received intravenous tenecteplase (0.25mg/kg), with treatment within 4.5 hours from when the person was last known well. Must not have used Edaravone, Edaravone Dexborneol or Butylphthalide after this stroke began, and no recent ACE inhibitor use as the record describes.
Main reasons for not taking part
- Planned for endovascular treatment
- Pregnancy
- Allergy to the study drug
- Other serious diseases
- Took part in another clinical trial within 3 months
Read by machine on 9 November 2026.
Where in China
- Department of Neurology, General Hospital of Northern Theater CommandShenyang, ChinaContact: Hui-Sheng Chen, Ph.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- General Hospital of Shenyang Military Region
- Trial code
- NCT07283159
- Record updated
- 23 January 2026
- Original description
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.Read full original descriptionShow less
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study
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.
Inclusion: 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: Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；; Allergy to the investigational drug(s)；; Comorbidity with other serious diseases; Planed for endovascular treatment; Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；; Pregnancy；; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.