Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
NCT ID: NCT06211712
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-04-17
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Human Urinary Kallidinogenase
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Stroke Association
UNKNOWN
Huashan Hospital
OTHER
Responsible Party
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Qiang Dong
Chief physician
Principal Investigators
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Qiang Dong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Wenjie Cao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2023-707
Identifier Type: -
Identifier Source: org_study_id