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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
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.
Huashan Hospital
Shanghai, China
RECRUITINGASPECT score evaluated using routine CT
Time frame: on day 7 after EVT
Modified Rankin Scale (mRS) score
Time frame: on day 90 after EVT
Barthel index
Time frame: on day 10 and 90 after EVT
Percentage of TIC ≥ 2b and mRS ≤2
Time frame: on day 90 after EVT
Changes of NIH Stroke Scale(NIHSS) score from baseline
Time frame: day 1, 4, 7 and 10 after EVT
Changes of vital signs from baseline
Time frame: day 1, 4, 7 and 10 after EVT
Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT
Time frame: day 7 after EVT
MRI and / or DWI examined
Time frame: within 10 days to determine the infarct volume
Recurrence rate of ischemic stroke
Time frame: within 90 days after EVT
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