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RECRUITING
NCT07283159
PHASE2

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Sponsor: General Hospital of Shenyang Military Region

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-01-20

Completion Date

2027-12-30

Last Updated

2026-01-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Human Urinary Kallidinogenase

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

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China