Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

Inclusion Criteria:

1. Age ≥18 years.

2. Having anterior circulation AIS within 24 hours of onset.

3. The NIHSS score at enrollment is 4 to 25.

4. Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA,or endovascular treatment including intra-arterial thrombolysis, mechanicalthrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.

5. Being independent in daily activities (mRS ≤1) before onset.

6. Patients or their legal representatives are able and willing to sign informedconsent forms.

Exclusion Criteria:

1. Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6or less confirmed by preoperational computed tomography scan.

2. Being already treated with HUK or any drugs containing HUK after onset.

3. Having an allergy history of HUK or drugs containing HUK, or other drugs and food.

4. Having a history of coagulation dysfunction, systemic bleeding, or thrombocytopenia;having hemorrhagic diseases at the time of enrollment, including cerebralhemorrhage, subarachnoid hemorrhage, epidural or subdural hematoma, gingivalbleeding, gastrointestinal bleeding, dermal ecchymosis, etc; taking anticoagulantsincluding warfarin, rivaroxaban, etc.; or taking heparin within 48 hours afterstroke onset.

5. Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugsregularly within one week before enrollment, including captopril, enalapril,benazepril, etc.

6. Having chronic liver disease or liver dysfunction, with elevated ALT/AST (>3.0×ULN ); or having kidney dysfunction or receiving dialysis, with elevated serumcreatinine (>2.0×ULN).

7. Having severe cardiopulmonary disease that are deemed unsuitable for the study bythe investigators.

8. Having contraindications for intravenous thrombolysis or endovascular treatment,including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.

9. Having lethal diseases with a life expectancy < 3 months.

10. Being pregnant or lactating; or women of child-bearing age not taking effectivecontraception, or having no negative pregnancy test record.

11. Being unable to complete the study due to mental illness, cognitive or emotionaldisorder, physical condition, geographical factors, etc.

12. Participating in another clinical trial currently.

13. Other conditions that investigators consider he/she is not appropriate toparticipate in this study.