Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
NCT07283159 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-01-23
Summary
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
Interventions
- DRUG
-
Human Urinary Kallidinogenase
Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.
Sponsors & Collaborators
-
General Hospital of Shenyang Military Region
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-20
- Primary Completion
- 2027-09-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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