Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

NCT07283159 · tracked via the Priya Life Science China tracker

Sponsor

General Hospital of Shenyang Military Region

Phase

Phase 2

Started

2026-01-20

Last updated

2026-01-23

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

Human Urinary Kallidinogenase

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * Planed 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.

Primary outcome measure(s)

proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) — 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Trial sites (1)

Facility	City	Region	Status
Department of Neurology, General Hospital of Northern Theater Command	Shenyang	China	Recruiting

More General Hospital of Shenyang Military Region trials in China

Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion Recruiting

Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) Recruiting

High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke Recruiting

Effects of Short-term Intensive Statin Therapy on Lipid Levels Recruiting

Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS) Recruiting

Other trials for the same condition

Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion Recruiting

Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds Recruiting

Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) Recruiting

Effects of Short-term Intensive Statin Therapy on Lipid Levels Recruiting

Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283159 on ClinicalTrials.gov ↗ ← All trials in China