This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
478
PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitors are a class of monoclonal antibody drugs that lower low-density lipoprotein cholesterol (LDL-C) by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL-C from the blood. This intervention involves the use of established PCSK9 inhibitor agents.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Dongguan Donghua Hospital
Dongguan, Guangdong, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
Time frame: 90 days after the stroke onset
Proportion of patients with early neurological improvement
Defined as a reduction of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) score or a complete resolution of neurological deficits (NIHSS=0) within 7 days after treatment.
Time frame: 7 days post-treatment
Incidence of target vessel reocclusion or recurrent infarction
Reocclusion of the responsible vessel confirmed by CTA/MRA/DSA, or new cerebral infarction in the same territory confirmed by diffusion-weighted MRI.
Time frame: 90 days after the stroke onset
Reduction amplitude of low-density lipoprotein (LDL-C)
Absolute and relative reduction of LDL-C levels from baseline to Day 7.
Time frame: Within 7 days post-treatment
Mortality rate
All-cause mortality at 90 days.
Time frame: 90 days after the stroke onset
Incidence of symptomatic hemorrhagic transformation
Hemorrhagic transformation associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.
Time frame: Within 7 days post-treatment
Incidence of acute liver injury
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal.
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Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
Hengzhou City People's Hospital, Guangxi
Hengzhou, Guangxi (Autonomous Region), China
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, China
Haikou People's Hospital
Haikou, Hainan, China
Hainan Provincial People's Hospital
Haikou, Hainan, China
...and 2 more locations
Time frame: Within 90 days post-treatment
Proportion of patients with early neurological deterioration
Defined as an increase of ≥4 points on the NIHSS score within 7 days post-treatment.
Time frame: Within 7 days post-treatment
Distribution of modified Rankin Scale (mRS) scores
Shift analysis of mRS scores at 90 days (range 0-6).
Time frame: 90 days after the stroke onset
Incidence of malignant brain edema
Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns.
Time frame: 48 to 96 hours after onset
Midline shift distance
Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.
Time frame: 72 to 96 hours after onset
Incidence of adverse events
All adverse events and serious adverse events, recorded and graded according to CTCAE v5.0.
Time frame: Within 90 days post-treatment