PCSK9 inhibitor: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years.
* Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023.
* Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
* Preoperative NIHSS score ≥ 4 and \< 25.
* Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention.
* LDL-C \> 1.8 mmol/L or non-HDL cholesterol \> 2.6 mmol/L.
* Signed informed consent provided by the patient or their legally authorized representative.
Exclusion Criteria:
* Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes).
* History of intracranial hemorrhage or systemic bleeding within the past 3 months.
* Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
* Severe hepatic impairment: ALT \> 3 times the upper limit of normal, INR \> 1.2, hepatic encephalopathy, or history of drug-induced liver injury.
* Use of PCSK9 inhibitors within 6 months prior to enrollment.
* Pre-stroke mRS ≥ 2.
* Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of \< 3 months.
* Pregnancy or lactation.
* Other neurological diseases that may interfere with neurological function assessment during follow-up.
* Allergy or intolerance to PCSK9 inhibitors or statins.
* Participation in another interventional clinical trial.
Primary outcome measure(s)
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points — 90 days after the stroke onset The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
Trial sites (12)
Facility
City
Region
Status
Fujian Medical University Union Hospital
Fuzhou
Fujian
Dongguan Donghua Hospital
Dongguan
Guangdong
Dongguan People's Hospital
Dongguan
Guangdong
Huadu District People's Hospital of Guangzhou
Guangzhou
Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou
Guangdong
Heyuan People's Hospital
Heyuan
Guangdong
Hengzhou City People's Hospital, Guangxi
Hengzhou
Guangxi (Autonomous Region)
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou
Hainan
Haikou People's Hospital
Haikou
Hainan
Hainan Provincial People's Hospital
Haikou
Hainan
The Second Affiliated Hospital of Hainan Medical University
Haikou
Hainan
Ganzhou City People's Hospital
Ganzhou
Jiangxi
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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