Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Enrolling; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Human Urinary Kallidinogenase

Study type: Interventional

Funder types: Other

Identifiers

NCT07283159

Y (2025) 357

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

Urinary Kallidinogenase with 0.15 PNA units dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily

Treatment:

Drug: Human Urinary Kallidinogenase

Control group

Placebo Comparator group

Description:

Urinary Kallidinogenase with placebo dissolved in 100 ml of normal saline, administered via slow intravenous drip over no less than 50 minutes, once daily

Treatment:

Drug: Human Urinary Kallidinogenase