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Study on Evolocumab for Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called evolocumab, also known by its code name AMG145, in patients who have experienced an acute myocardial infarction, commonly known as a heart attack. The study aims to compare the effectiveness of evolocumab, administered as a solution for injection, with standard treatment strategies in achieving specific cholesterol level goals. The main goal is to see if evolocumab can help reduce levels of LDL cholesterol, often referred to as "bad" cholesterol, by at least 50% and reach a target level of less than 1.4 mmol/L (or 55 mg/dL) over a period of 12 months.

Participants in the study will be randomly assigned to receive either evolocumab or the usual care strategies. The study will follow participants for up to 36 months, with regular check-ups to monitor cholesterol levels and other health indicators. These check-ups will occur at various intervals, including 6 weeks, 22 weeks, and 12 months after starting the treatment, and may continue up to 24 months or longer, depending on the availability of data. The study will also look at how quickly participants can reach their target cholesterol levels and any changes in other types of cholesterol and fats in the blood.

The purpose of this study is to determine if evolocumab is more effective than standard treatments in helping patients who have had a heart attack achieve healthier cholesterol levels, which could potentially reduce the risk of future heart-related problems. By participating in this study, researchers hope to gather valuable information that could improve treatment strategies for managing cholesterol levels in patients with heart disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, informed consent is obtained in writing. This confirms understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes a diagnosis of acute myocardial infarction (heart attack) and other specific criteria.

    Eligibility criteria include being male or female, having a diagnosis of STEMI or NSTEMI, and meeting certain health conditions such as diabetes or previous heart conditions.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either the medication evolocumab or standard care. This process is called randomization.

  4. Step 4

    Medication administration

    If assigned to the evolocumab group, the medication is administered as a subcutaneous injection using a pre-filled pen. The dosage is 140 mg.

    The frequency and duration of administration are determined by the study protocol and will be explained during the trial.

  5. Step 5

    Follow-up visits

    Follow-up visits are scheduled at 6 weeks, 22 weeks, and 12 months after randomization. Additional visits may occur at 16, 20, 28, and 32 months if data are available.

    During these visits, LDL-C (a type of cholesterol) levels are assessed to monitor progress.

  6. Step 6

    End of trial

    The trial aims to demonstrate a reduction in LDL-C levels by at least 50% from baseline and achieve a target LDL-C level of less than 1.4 mmol/L at 12 months.

    The trial is estimated to end by September 29, 2026.

Who can join the trial?

15 criteria

  • Must be male or female.
  • Must have a diagnosis of STEMI (a type of heart attack) defined as:
    • Symptoms of a heart attack lasting at least 30 minutes.
    • Occurred within the previous 24 hours.
    • New persistent ST-segment elevation (a specific change seen on an ECG test) of at least 1 mm in 2 or more continuous ECG leads.
    • Need for a procedure called primary PCI (a treatment to open blocked heart arteries).
    • Must be over 55 years old.
    • Or, must have a non-ST-segment elevation myocardial infarction (NSTEMI) (another type of heart attack) defined by:
      • Angiography (an imaging test of the heart's blood vessels) performed within 72 hours.
      • Need for a procedure called percutaneous coronary intervention (a treatment to open blocked heart arteries).
      • Having at least one of the following risk factors:
        • Diabetes.
        • Peripheral arterial disease (narrowing of the blood vessels outside of the heart).
        • Multitruncular disease (disease affecting multiple large blood vessels) confirmed by angiography.
        • Previous heart attack or stroke without lasting effects before joining the study.
        • eGFR creatinine clearance (a measure of kidney function) between 15 to 45 mL/min/1.73 m² calculated using the MDRD formula at the time of joining the study.
        • Must be taking a statin (a type of medication to lower cholesterol) at the highest dose they can tolerate as part of their standard treatment, with the intention to start this treatment as soon as possible when joining the study.
        • Must provide written informed consent at the time of joining the study.

Who cannot join the trial?

1 criterion

  • Patients who have had a recent acute myocardial infarction (a heart attack) cannot participate.
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Investigated drugs

Evolocumab is a medication used in this clinical trial to help lower levels of LDL cholesterol, which is often referred to as "bad" cholesterol. It works by blocking a protein in the liver that is responsible for controlling the amount of cholesterol in the blood. By doing this, evolocumab can help reduce the risk of heart-related problems. In this trial, the goal is to see if evolocumab is better than the usual treatments in significantly lowering LDL cholesterol levels over a period of 12 months.

What is already known about the treatment

Evolocumab – Evolocumab is administered as a subcutaneous injection, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating acute myocardial infarction, which is a type of heart attack. The main therapeutic use of evolocumab is to significantly lower LDL cholesterol levels, often referred to as "bad" cholesterol, in the blood. It works by inhibiting a protein called PCSK9, which helps the liver remove LDL cholesterol from the bloodstream. Evolocumab is classified as a PCSK9 inhibitor, a type of medication used to manage cholesterol levels.

Investigated diseases

Acute Myocardial Infarction – Acute myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can obstruct the flow of blood. The progression of the disease involves the death of heart muscle tissue due to the lack of oxygen-rich blood. Symptoms may include chest pain, shortness of breath, and other discomforts. Over time, the heart's ability to pump blood effectively can be compromised, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518195-31-00Protocol codeAPHP201075Estimated enrolment2 599 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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