Tests kallidinogenase with reteplase clot-busting treatment for acute ischemic stroke
Tests kallidinogenase added to reteplase in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke
Key facts
- Where
- Changchun, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an acute ischemic stroke who start clot-dissolving treatment with reteplase within 4.5 hours of last being well.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Acute ischemic stroke, 4.5 hours or less since last known well, NIHSS score from 6 to 16. First stroke, or an earlier stroke with mRS 1 or lower before this one.
- Earlier treatment
- Must receive reteplase intravenous thrombolysis. Cannot have used ACE inhibitor drugs within 5 half-lives before starting the study drug. Cannot have used Edaravone, Edaravone Dexborneol or Butylphthalide products since this stroke began.
Main reasons for not taking part
- Early CT score (ASPECTS) of 6 or lower
- Planned endovascular treatment
- Severe uncontrolled high blood pressure (180 mmHg or higher systolic, or 110 mmHg or higher diastolic)
- Pregnant or breastfeeding, or planning pregnancy within 90 days
- Severe kidney, liver or heart disease, or another illness with expected survival under 90 days
Read by machine on 9 November 2026.
Where in China
- China-Japan Union Hospital of JiLin UniversityChangchun, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- China-Japan Union Hospital
- Trial code
- NCT07483281
- Record updated
- 30 March 2026
- Original description
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 strokeRead full original descriptionShow less
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke
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
Inclusion: 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; 6 ≤NIHSS≤ 16; Meet the clinical thrombolysis indications in the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke and receive reteplase intravenous thrombolysis; Have provided signed written informed consent from the patient or the patient's legal representative.
Exclusion: 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; History of severe food or drug allergies, or prior allergy or intolerance to urinary kallidinogenase for injection; Heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, severe arrhythmia, or second/third-degree cardiac conduction obstruction within 6 months before randomization; Drug abuse or addiction in the past year; Concurrent malignant tumors or severe systemic diseases with an expected survival < 90 days; Participation in any interventional drug or device clinical trial within 3 months before screening; Preoperative non-contrast head CT shows Alberta Stroke Program Early CT Score (ASPECTS) ≤ 6; Severe uncontrolled hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg; Severe mental disorders or dementia unable to complete the informed consent and follow-up; Renal failure or severe renal impairment (creatinine clearance < 30 mL/min) at screening; Liver function impairment: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal, or liver diseases (e.g., acute/chronic hepatitis, cirrhosis); Presence of contraindications to intravenous thrombolysis; Planed for endovascular treatment; Patients with fracture, claudication and other factors affecting functional outcome score upon admission; Use of Edaravone Injection, Edaravone Dexborneol Injection, Sublingual Edaravone Dexborneol, Butylphthalide Injection or Capsules after the onset of the current episode; Pregnant or lactating women, or patients planning pregnancy within 90 days; Patients deemed unsuitable for the study by the investigator.