PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

NCT ID: NCT07174375

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-12-15

Brief 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard therapy plus PCSK9 inhibitor

Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations.

Group Type: EXPERIMENTAL

PCSK9 inhibitor

Intervention Type: DRUG

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.

Standard therapy alone

Patients in the Standard therapy alone (control) group will receive standard of care treatment. If low-density lipoprotein cholesterol (LDL-C) levels fail to meet target goals after 7 days, cholesterol absorption inhibitors (e.g., Ezetimibe or Hypemab) may be administered. If LDL-C levels still remain suboptimal after 1 month, PCSK9 inhibitors may be added to the treatment regimen.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Evolocumab; Alirocumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Dongguan Donghua Hospital

Dongguan, Guangdong, China

Dongguan People's Hospital

Dongguan, Guangdong, China

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

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

Countries

China

Central Contacts

Kaibin Huang, Ph.D.

Role: CONTACT

hkb@smu.edu.cn

+8615915751065

Suyue Pan, Ph.D.

Role: CONTACT

pansuyue@smu.edu.cn

+86 02062787648

Facility Contacts

Youai Chen, M.D.

Role: primary

+8613192657996

Pengxiang Li, M.D.

Role: primary

13907615510

Other Identifiers

NFEC-2025-213

Identifier Type: -

Identifier Source: org_study_id