Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

NCT ID: NCT07283159

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2027-12-30

Brief 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

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

Human Urinary Kallidinogenase

Intervention Type: DRUG

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

Control group

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

Group Type: PLACEBO_COMPARATOR

Human Urinary Kallidinogenase

Intervention Type: DRUG

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

Interventions

Human Urinary Kallidinogenase

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hui-Sheng Chen, Ph.D.

Role: primary

chszh@aliyun.com

+86 13352452086

Other Identifiers

Y (2025) 357

Identifier Type: -

Identifier Source: org_study_id