RecruitingNot ApplicableNCT06211712

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

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

Sponsor

Huashan Hospital

Enrollment

120 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

Summary

The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria7

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.

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Interventions

DRUGExperimental: Human Urinary Kallidinogenase

Before the first day of endovascular therapy (non-bridging), dissolve Human Urinary Kallidinogenase in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.

DRUGPlacebo Comparator: Placebo

Before the first day of endovascular therapy (non-bridging), dissolve placebo in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.