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Clinical Trials in China / NCT07174375
Starting soon Phase 2/3

PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

NCT07174375 · tracked via the Priya Life Science China tracker
Sponsor
Nanfang Hospital, Southern Medical University
Phase
Phase 2/3
Started
2025-09-15
Last updated
2025-09-15

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

PCSK9 inhibitor →

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)

Trial sites (12)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07174375 on ClinicalTrials.gov ↗ ← All trials in China