Clinical trial NCT06211712: Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Stroke Association
First posted: 2024-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

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 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±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.

Eligibility criteria: 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 outcomes:
measure: ASPECT score evaluated using routine CT
timeFrame: on day 7 after EVT
measure: Modified Rankin Scale (mRS) score
timeFrame: on day 90 after EVT
Secondary outcomes:
measure: Barthel index
timeFrame: on day 10 and 90 after EVT
measure: Percentage of TIC ≥ 2b and mRS ≤2
timeFrame: on day 90 after EVT
measure: Changes of NIH Stroke Scale(NIHSS) score from baseline
timeFrame: day 1, 4, 7 and 10 after EVT
measure: Changes of vital signs from baseline
timeFrame: day 1, 4, 7 and 10 after EVT
measure: Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT
timeFrame: day 7 after EVT
measure: MRI and / or DWI examined
timeFrame: within 10 days to determine the infarct volume
measure: Recurrence rate of ischemic stroke
timeFrame: within 90 days after EVT
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Qiang Dong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Wenjie Cao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: