Tenecteplase combined with urinary kallidinogenase for acute ischemic stroke

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

This trial tests whether adding urinary kallidinogenase to tenecteplase helps adults with acute ischemic stroke recover better when treated within 4.5 hours of symptom onset.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT07283159 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional study enrolling adults with neuroimaging-confirmed acute ischemic stroke who receive intravenous tenecteplase (0.25 mg/kg) within 4.5 hours and have NIHSS ≥6. Participants will receive human urinary kallidinogenase (HUK) in addition to tenecteplase to evaluate safety and effects on neurological recovery and collateral circulation. Key outcomes include changes in neurological function scores and rates of hemorrhagic complications during acute and short-term follow-up. The protocol builds on preclinical and clinical evidence that HUK can salvage the ischemic penumbra and promote collateral flow when combined with thrombolytics.

Who should consider this trial

Good fit: Adults (≥18 years) with imaging-confirmed acute ischemic stroke treated with tenecteplase within 4.5 hours, NIHSS ≥6, and no disabling prior stroke (mRS ≤1) are the intended participants.

Not a fit: Patients planned for endovascular therapy, those beyond the 4.5-hour window, pregnant individuals, those recently on ACE inhibitors, with major comorbidities, or allergic to the drug are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve early neurological recovery and increase salvage of the ischemic penumbra without raising bleeding risk.

How similar studies have performed: Prior studies combining HUK with intravenous alteplase have reported improved neurological outcomes without increased hemorrhage, but combination with tenecteplase is novel and unreported.

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.

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (RECRUITING)

Conditions: Ischemic Stroke