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

Prior treatment

• 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

Other illness

• 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

Lab values

• 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)

Other

• 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

• 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