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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06211712
Other study ID # KY2023-707
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 2025

Study information

Verified date April 2024
Source Huashan Hospital
Contact Qiang Dong, M.D.
Phone 13701747065
Email 13701747065@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 days. The safety of Human Urinary Kallidinogenase will be evaluated through 90 days. End of study evaluation will occur at day 90 or premature discontinuation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged). 2. Age =18 years old and =80 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Huashan Hospital Shanghai Stroke Association

Outcome

Type Measure Description Time frame Safety issue
Primary ASPECT score evaluated using routine CT on day 7 after EVT
Primary Modified Rankin Scale (mRS) score on day 90 after EVT
Secondary Barthel index on day 10 and 90 after EVT
Secondary Percentage of TIC = 2b and mRS =2 on day 90 after EVT
Secondary Changes of NIH Stroke Scale(NIHSS) score from baseline day 1, 4, 7 and 10 after EVT
Secondary Changes of vital signs from baseline day 1, 4, 7 and 10 after EVT
Secondary Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT day 7 after EVT
Secondary MRI and / or DWI examined within 10 days to determine the infarct volume
Secondary Recurrence rate of ischemic stroke within 90 days after EVT
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