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Study of Evolocumab to Prevent Heart Disease Events in High-Risk Patients Without Previous Heart Attack or Stroke

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people at high risk of cardiovascular disease who have not previously experienced a myocardial infarction (heart attack) or stroke. The research examines the effectiveness of a medication called evolocumab (also known as AMG 145) compared to placebo in preventing serious heart and blood vessel problems. Evolocumab is a medication that helps lower cholesterol levels in the blood.

The study aims to determine if evolocumab can reduce the risk of death from coronary heart disease, heart attacks, and strokes in people receiving standard cholesterol-lowering therapy. The medication is given as an injection under the skin using a pre-filled pen that contains 140 mg of evolocumab.

During the study, participants will receive either evolocumab injections or placebo injections. The treatment period lasts for 72 weeks, during which participants will continue their usual cholesterol-lowering medications. The study will track various heart-related health events, including arterial revascularization (procedures to restore blood flow in blocked arteries) and death from heart-related causes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to receive either evolocumab or a placebo (an inactive substance).

    The assignment is double-blind, which means neither you nor your doctor will know which treatment you are receiving.

  2. Step 2

    Treatment administration

    You will receive subcutaneous injections (under the skin) of either evolocumab or placebo.

    The treatment will continue throughout the study period, which runs until June 30, 2025.

  3. Step 3

    Ongoing medical care

    You will continue receiving your regular lipid-lowering therapy (medications to control cholesterol) throughout the study.

    Regular monitoring of your heart health and blood tests will be conducted to track your progress.

  4. Step 4

    Health monitoring

    Your health will be monitored for important heart-related events, including:

    - Heart problems (coronary heart disease)

    - Heart attacks (myocardial infarction)

    - Brain blood vessel blockages (ischemic stroke)

    - Need for blood vessel procedures (arterial revascularization)

  5. Step 5

    Study completion

    The study will conclude on June 30, 2025.

    Your participation will help determine if evolocumab reduces the risk of serious heart-related events in patients at high cardiovascular risk.

Who can join the trial?

20 criteria

  • Age requirements: men must be 50 years or older, women must be 55 years or older, and all participants must be under 80 years old
  • Must have specific blood fat levels:
    • LDL (bad cholesterol) of at least 90 mg/dL, or
    • non-HDL cholesterol of at least 120 mg/dL, or
    • apolipoprotein B of at least 80 mg/dL
    • Must have at least one of these heart-related conditions:
      • Significant heart artery disease with previous procedures or blockages
      • Significant blood vessel problems affecting the brain
      • Significant blood vessel problems in the legs
      • Diabetes with complications affecting small blood vessels
      • Must have at least one additional risk factor:
        • Blood vessel disease in multiple areas of the body
        • Diabetes or metabolic syndrome
        • Very high cholesterol levels
        • High levels of lipoprotein(a) in blood
        • Inherited high cholesterol
        • Family history of early heart disease
        • High levels of inflammation markers in blood
        • Current smoker
        • Over 65 years of age
        • Early menopause (before age 40)
        • Reduced kidney function
        • High calcium buildup in heart arteries

Who cannot join the trial?

15 criteria

  • Prior history of heart attack (myocardial infarction) or stroke
  • Currently participating in other clinical research studies
  • Known allergies to the study medication (evolocumab) or its components
  • Significant liver disease or abnormal liver function tests
  • Severe kidney problems (severe renal impairment)
  • Uncontrolled high blood pressure
  • History of serious bleeding disorders
  • Pregnant women or women planning to become pregnant during the study
  • Breastfeeding mothers
  • Active cancer or cancer treatment within the past 5 years
  • History of substance abuse within the past year
  • Mental conditions that could interfere with study participation
  • Unable to provide informed consent
  • History of not following medical treatment plans
  • Taking medications that could interact with the study drug
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Investigated drugs

Evolocumab is a medication that helps lower cholesterol levels in the blood. It works by blocking a protein that prevents the liver from removing LDL (bad) cholesterol from the blood. This medication is used in patients who have a high risk of cardiovascular problems but haven't had a heart attack or stroke. It is given alongside other cholesterol-lowering treatments to help reduce the risk of serious heart problems. Placebo is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used to help determine if the actual medication is effective. Note: Both medications in this trial are given to patients who are already receiving optimized lipid-lowering therapy as part of their standard treatment for managing cardiovascular risk.

What is already known about the treatment

Evolocumab - A biologic medication administered via subcutaneous injection that belongs to the class of PCSK9 inhibitors, designed to lower cholesterol levels in the blood. This medication works by blocking the PCSK9 protein, which allows more LDL receptors to remain active on liver cells, resulting in increased removal of LDL (bad) cholesterol from the bloodstream. Evolocumab is primarily used in patients at high risk of cardiovascular events who haven't experienced a previous heart attack or stroke, particularly when conventional cholesterol-lowering treatments aren't sufficient. The medication represents an important advancement in preventive cardiovascular medicine, showing significant effectiveness in reducing the risk of heart disease, stroke, and the need for arterial revascularization procedures.

Investigated diseases

  • Coronary Heart Disease (CHD)

    A condition where the main blood vessels that supply the heart become narrowed or blocked by fatty deposits. This process develops gradually over time as cholesterol and other materials build up on the inner walls of arteries. The reduced blood flow can cause chest pain and eventually lead to a heart attack if a coronary artery becomes completely blocked. The disease often progresses silently for many years before showing symptoms.

  • Myocardial Infarction (MI)

    A condition where part of the heart muscle is damaged due to insufficient blood supply. It occurs when one or more coronary arteries become blocked, preventing oxygen-rich blood from reaching certain areas of the heart. The affected heart muscle begins to die within minutes of being deprived of oxygen. The damage can vary in size and severity depending on the duration and location of the blockage.

  • Ischemic Stroke

    A condition where blood flow to a part of the brain is blocked, typically by a blood clot. When brain tissue is deprived of oxygen and nutrients, brain cells begin to die within minutes. The effects of an ischemic stroke depend on which area of the brain is affected and how much tissue is damaged. The condition can cause sudden weakness, confusion, or difficulty speaking.

  • Cardiovascular Disease

    A group of disorders affecting the heart and blood vessels throughout the body. The condition typically develops when arteries become hardened and narrowed due to the buildup of fatty deposits. This process can affect blood vessels throughout the body, including those supplying the heart, brain, and other vital organs. The disease often develops gradually over many years.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503673-38-00Protocol code20170625Estimated enrolment10 919 patientsSponsorAmgen Inc.

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