PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy (PCSK9-PROVE)

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: PCSK9 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07174375

NFEC-2025-213

Details and patient eligibility

About

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.

Enrollment: 478 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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478 participants in 2 patient groups

Standard therapy plus PCSK9 inhibitor

Experimental group

Description:

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.

Treatment:

Drug: PCSK9 inhibitor

Standard therapy alone

No Intervention group

Description:

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.