Status:
RECRUITING
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Shanghai Stroke Association
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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 occlu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06211712
Start Date
April 17 2024
End Date
December 1 2025
Last Update
December 4 2024
Active Locations (1)
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1
Huashan Hospital
Shanghai, China, 200040