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Study of Orticumab in Adults with Previous Heart Attack and High Coronary Inflammation Measured by CT Scan

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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 patients with Atherosclerotic Cardiovascular Disease who have previously experienced a myocardial infarction (heart attack) and show signs of inflammation in their coronary arteries. The study will test a medication called orticumab, which is given as an injection, to determine its effects on reducing inflammation in the heart's blood vessels.

The research will examine how well orticumab works compared to placebo in treating coronary artery inflammation. The inflammation will be measured using a special technique called Fat Attenuation Index score, which is determined through Coronary Computed Tomography Angiography (a detailed heart imaging scan). The study will look at three main blood vessels of the heart: the right coronary artery, left anterior descending artery, and left circumflex artery.

Participants in this study will receive treatment for 6 months. During this time, they will undergo various health checks, including blood tests, physical examinations, and heart scans. The study will monitor both the effectiveness of the treatment and any side effects that may occur. Throughout the study, participants will continue taking their regular heart medications as prescribed by their doctors.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility confirmation

    You will be evaluated to confirm you had a heart attack (myocardial infarction) more than 180 days ago

    Your medical records will be reviewed to verify you are on stable heart medication treatment

    A special heart scan (CCTA) will be performed to measure inflammation in your heart arteries

    Basic health measurements will be taken, including your weight and height to calculate body mass index

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either orticumab or a placebo (inactive substance)

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be given by injection

  3. Step 3

    Treatment period

    The treatment period will last for 6 months

    Regular health checks will include:

    Blood pressure and pulse rate measurements

    Blood tests for safety monitoring

    Physical examinations

    Monitoring for any side effects

  4. Step 4

    Final evaluation

    After 6 months of treatment, you will have another heart scan (CCTA)

    The scan will measure changes in inflammation in your heart arteries

    Final health assessments will be performed

    Blood tests will check for antibodies and medication levels in your body

Who can join the trial?

12 criteria

  • You must be able to provide informed consent and follow all study requirements and schedules
  • You must be at least 180 days after having a heart attack (myocardial infarction) without experiencing severe chest pain. Patients who had previous heart procedures (PCI - a procedure to open blocked arteries) can participate
  • You must be on stable heart medications as recommended by guidelines, including:
    • Cholesterol-lowering medications (statins or PCSK9 inhibitors)
    • Blood-thinning medications (antiplatelets)
    • Blood pressure medications
    • You must have a special heart scan (CCTA) showing specific levels of inflammation around your heart arteries (FAI Score)
    • Your body mass index (BMI) must be 40 or less
    • You must be at least 18 years old
    • For women participants:
      • Must not be pregnant or breastfeeding
      • Must be either post-menopausal, surgically sterilized, or using effective birth control
      • For men participants:
        • Must use appropriate contraception (such as condoms) if partner can become pregnant
        • Must continue contraception for 100 days after last study treatment

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Inability to undergo CCTA (Coronary CT Angiography - a special X-ray examination of heart blood vessels)
  • Known allergies to the study medication (orticumab)
  • Current participation in other clinical trials
  • History of severe allergic reactions to medical drugs
  • Pregnancy or breastfeeding
  • Serious heart rhythm problems
  • Severe kidney or liver disease
  • Active cancer or cancer treatment in the past 5 years
  • Major surgery in the past 3 months
  • Uncontrolled high blood pressure
  • Severe bleeding disorders
  • History of stroke in the past 6 months
  • Severe mental health conditions that could affect participation
  • Drug or alcohol abuse
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Investigated drugs

Orticumab is an investigational medication being studied for treating people who have previously had a heart attack (myocardial infarction) and show signs of inflammation in their coronary arteries. This medication is designed to target and reduce inflammation in the blood vessels around the heart. It works differently from standard heart medications by focusing specifically on the inflammatory process that can contribute to heart disease.

What is already known about the treatment

Orticumab - An investigational medication administered through intravenous infusion, specifically being studied for the treatment of atherosclerotic cardiovascular disease in patients with a history of myocardial infarction (heart attack) who show elevated coronary inflammation. This therapeutic agent belongs to the class of targeted immunotherapies and works by modulating inflammatory processes in coronary arteries, particularly focusing on reducing inflammation as measured by the Fat Attenuation Index (FAI) in coronary CT scans. The medication is currently undergoing clinical trials to evaluate its effectiveness in reducing cardiovascular inflammation and potentially preventing subsequent cardiac events in high-risk patients.

Investigated diseases

Atherosclerotic Cardiovascular Disease - A condition where fatty deposits (plaque) build up inside the arteries that supply blood to the heart. These deposits gradually accumulate over time, causing the arteries to become narrow and stiff. The plaque consists of fat, cholesterol, calcium, and other substances found in the blood. As arteries become narrower, blood flow to the heart muscle becomes restricted. The disease typically develops over many years and can affect multiple coronary arteries simultaneously. This condition can progress silently for years before causing noticeable symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520464-17-00Protocol codeORT-2024-02Estimated enrolment240 patientsSponsorAbcentra LLC

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