Actively Recruiting
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
Led by General Hospital of Shenyang Military Region · Updated on 2026-01-23
200
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (mRS1)
- Signed informed consent
You will not qualify if you...
- Planned 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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