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

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Yang
• Treatments: Kallikreins

Criteria

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.