Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Human Urinary Kallidinogenase

Treatment groups

200 Participants
are divided into 2 treatment groups