Tenecteplase combined with urinary kallidinogenase for acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Neurology, General Hospital of Northern Theater Command
  Shenyang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.