Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Union Hospital

About this trial

This study is a multicentre, randomized, blinded-endpoint trial that aims to evaluate the efficacy and safety of human urinary kallidinogenase combined with reteplase intravenous thrombolysis in the treatment of acute ischemic stroke

Eligibility criteria

Qualifiers

Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023

Age ≥ 18 years

The time from last known well to treatment is within 4.5 hours

First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset

Disqualifiers

Preoperative non-contrast head CT shows Alberta Stroke Program Early CT Score (ASPECTS) ≤ 6

Presence of contraindications to intravenous thrombolysis

Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment

Planed for endovascular treatment

Trial design

Treatments tested in this trial

  • Human Urinary Kallidinogenase
  • Clinical Routine Treatment

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators