Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Inclusion Criteria:

1. Age ≥18 years old;
2. Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
3. Moderate to severe stenosis or occlusion of offending vessels;
4. The mRS Score ≤2 before onset;
5. Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Exclusion Criteria:

1. Transient ischemic attack;
2. Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
3. Severe disturbance of consciousness:GCS ≤8;
4. Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
5. Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg;
6. Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN);
7. Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);
8. Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
9. Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;
10. Unwilling to be followed up or poor treatment compliance;
11. Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
12. Other conditions considered by the investigator to be inappropriate for enrollment.