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Not yet recruiting NCT07174375

PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

Phase II / Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCSK9 inhibitor.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of PCSK9 Inhibitors in Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy: A Prospective, Multicenter, Open-Label, Parallel, Randomized Controlled Clinical Trial

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points [Time frame: 90 days after the stroke onset]
Secondary outcome measures (11)
  • Proportion of patients with early neurological improvement [Time frame: 7 days post-treatment]
  • Incidence of target vessel reocclusion or recurrent infarction [Time frame: 90 days after the stroke onset]
  • Reduction amplitude of low-density lipoprotein (LDL-C) [Time frame: Within 7 days post-treatment]
  • Mortality rate [Time frame: 90 days after the stroke onset]
  • Incidence of symptomatic hemorrhagic transformation [Time frame: Within 7 days post-treatment]
  • Incidence of acute liver injury [Time frame: Within 90 days post-treatment]
  • Proportion of patients with early neurological deterioration [Time frame: Within 7 days post-treatment]
  • Distribution of modified Rankin Scale (mRS) scores [Time frame: 90 days after the stroke onset]
  • Incidence of malignant brain edema [Time frame: 48 to 96 hours after onset]
  • Midline shift distance [Time frame: 72 to 96 hours after onset]
  • Incidence of adverse events [Time frame: Within 90 days post-treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 12 centers
  • Fujian Medical University Union Hospital — Fuzhou
  • Dongguan Donghua Hospital — Dongguan
  • Dongguan People's Hospital — Dongguan
  • Huadu District People's Hospital of Guangzhou — Guangzhou
  • Nanfang Hospital of Southern Medical University — Guangzhou
  • Heyuan People's Hospital — Heyuan
  • Hengzhou City People's Hospital, Guangxi — Hengzhou
  • Hainan Provincial Hospital of Traditional Chinese Medicine — Haikou
  • … and 4 more centers

Identifiers

NCT: NCT07174375 · NFEC-2025-213

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗