drugset / Trial / NCT07283159

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

NCT07283159

Phase 2 Recruiting 200 enrolled General Hospital of Shenyang Military Region
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-01-20
Primary completion
2027-09-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Human Urinary Kallidinogenase Protein / enzyme biologic 0.15 unknown Intravenous

Indications