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NCT Number: NCT07174375

PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCSK9 inhibitor

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.

Other names: Evolocumab, Alirocumab

Primary outcomes

  1. Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points

    Time frame: 90 days after the stroke onset

    The proportion of mordified Rankin Scale of 0 to 2 points at 90 days

Secondary outcomes

  1. Proportion of patients with early neurological improvement

    Time frame: 7 days post-treatment

    Defined as a reduction of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) score or a complete resolution of neurological deficits (NIHSS=0) within 7 days after treatment.

  2. Incidence of target vessel reocclusion or recurrent infarction

    Time frame: 90 days after the stroke onset

    Reocclusion of the responsible vessel confirmed by CTA/MRA/DSA, or new cerebral infarction in the same territory confirmed by diffusion-weighted MRI.

  3. Reduction amplitude of low-density lipoprotein (LDL-C)

    Time frame: Within 7 days post-treatment

    Absolute and relative reduction of LDL-C levels from baseline to Day 7.

  4. Mortality rate

    Time frame: 90 days after the stroke onset

    All-cause mortality at 90 days.

  5. Incidence of symptomatic hemorrhagic transformation

    Time frame: Within 7 days post-treatment

    Hemorrhagic transformation associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.

  6. Incidence of acute liver injury

    Time frame: Within 90 days post-treatment

    Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal.

  7. Proportion of patients with early neurological deterioration

    Time frame: Within 7 days post-treatment

    Defined as an increase of ≥4 points on the NIHSS score within 7 days post-treatment.

  8. Distribution of modified Rankin Scale (mRS) scores

    Time frame: 90 days after the stroke onset

    Shift analysis of mRS scores at 90 days (range 0-6).

  9. Incidence of malignant brain edema

    Time frame: 48 to 96 hours after onset

    Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns.

  10. Midline shift distance

    Time frame: 72 to 96 hours after onset

    Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.

  11. Incidence of adverse events

    Time frame: Within 90 days post-treatment

    All adverse events and serious adverse events, recorded and graded according to CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaibin Huang, Ph.D.

CONTACT

[email protected]

+8615915751065

Suyue Pan, Ph.D.

CONTACT

[email protected]

+86 02062787648

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study 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

Acronym: PCSK9-PROVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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