NCT07283159RecruitingPhase 2
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 20 Jan 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT07283159
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 20 Jan 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
- Allergy to the investigational drug(s)；
Other illness
- Comorbidity with other serious diseases;
Other
- Planed for endovascular treatment;
- Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
- Pregnancy；
- Participating in other clinical trials within 3 months;
- Patients not suitable for the study considered by researcher.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.