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Clinical Trials in China / NCT06211712
Recruiting Not applicable

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

NCT06211712 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2024-04-17
Last updated
2024-12-04

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Experimental: Human Urinary KallidinogenasePlacebo Comparator: Placebo

Experimental: 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.

Placebo 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged). 2. Age ≥18 years old. 3. The mRS score was 0-1 before onset. 4. ASPECT score of infarction on emergency CT ≥7. 5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery). 6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \<100 mL, and low perfusion brain tissue volume/ infarct core volume\> 1.2. 7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate). Exclusion Criteria: 1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications. 2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.). 3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases. 4. Taking ACEI antihypertensive drugs regularly and could not stop. 5. Participant with major surgery or severe trauma in the past 2 weeks. 6. Poor compliance and cannot fully follow the study protocol. 7. Pregnancy or lactation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06211712 on ClinicalTrials.gov ↗ ← All trials in China