Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion

A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.

Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:

• Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
• Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.

The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.

End of study evaluation will occur at day 90±7 or premature discontinuation.

Inclusion criteria

• Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
• Age ≥18 years old.
• The mRS score was 0-1 before onset.
• ASPECT score of infarction on emergency CT ≥7.
• Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
• Emergency CTP or DWI suggesting infarct core body ≥10 mL and <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.2.
• Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).

Exclusion criteria

• Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
• CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
• Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
• Taking ACEI antihypertensive drugs regularly and could not stop.
• Participant with major surgery or severe trauma in the past 2 weeks.
• Poor compliance and cannot fully follow the study protocol.
• Pregnancy or lactation.