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Bempedoic acid in drug combination for patients with coronary artery disease without prior cardiovascular events

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

The study focuses on coronary atherosclerosis, a condition where fatty deposits called plaque build up inside the arteries that supply blood to the heart. Participants will receive a combination of three oral medicines: a high‑intensity statin such as atorvastatin (or rosuvastatin), together with bempedoic acid and ezetimibe. The purpose is to determine whether this triple therapy can lower the plaque burden and make the plaque more stable.

During the trial, participants will take the study drugs daily for several months and attend regular visits that may include heart‑artery imaging scans and blood tests. These tests will measure changes in plaque size, levels of “bad cholesterol” (LDL-C), and other health markers, while safety is checked by recording any side effects or discontinuations of the medication.

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

    Baseline assessment

    After joining, a series of measurements are performed to record the current state of the heart arteries and blood cholesterol levels. these include a scan of the coronary arteries to measure plaque, and blood tests that check cholesterol and other markers.

    The results provide a reference point for later comparison.

  2. Step 2

    Start triple therapy

    The patient begins taking three oral medicines every day.

    atorvastatin 40 mg, a high‑intensity statin that lowers bad cholesterol (ldl‑c).

    rosuvastatin 20 mg, another high‑intensity statin with a similar purpose.

    bempedoic acid and ezetimibe combination 180.10 mg, which also lowers cholesterol through a different mechanism.

    All three pills are taken once daily with or without food for the whole duration of the study.

  3. Step 3

    First follow‑up visit (month 3)

    After three months, the patient returns for a visit.

    Blood is drawn to measure cholesterol, triglycerides, and inflammation markers.

    A repeat scan may be performed to see early changes in plaque.

    Any side effects are recorded and medication adherence is checked.

  4. Step 4

    Second follow‑up visit (month 6)

    At six months, another visit occurs.

    The same set of blood tests and imaging are repeated.

    The data are compared with the baseline to assess progress.

    The study team reviews any adverse events and may adjust support.

  5. Step 5

    Final assessment (end of treatment)

    At the end of the treatment period, which continues until the study end date (approximately two years after the start), a comprehensive evaluation is performed.

    A final coronary artery scan measures the total plaque burden and composition.

    Final blood tests assess cholesterol levels and other biomarkers.

    All information is used to determine the effect of the triple therapy on plaque regression and stability.

    The patient’s participation ends after this assessment.

Who can join the trial?

4 criteria

  • Be at least 22 years old.
  • Agree to join the study and sign the informed consent form.
  • Never have taken medicines that lower cholesterol (called lipid‑lowering treatment‑naïve).
  • Have extensive coronary atherosclerosis, meaning plaque is clearly seen in at least five heart‑artery sections defined by the American Heart Association (AHA), the blockage is rated as CAD‑RADS category 1‑3, doctors do not expect you will need a revascularisation procedure during the trial, and your untreated “bad” cholesterol (LDL‑C) level is between 2.6 and 4.5 mmol/L.

Who cannot join the trial?

22 criteria

  • Having a known or suspected genetic condition that causes very high cholesterol, such as familial hypercholesterolemia (whether one or both parents passed the gene) or familial combined hyperlipidaemia (high blood fats from genetics).
  • Being pregnant or currently breastfeeding.
  • Having a body weight that gives a Body Mass Index (BMI) greater than 35 kg/m² (BMI is a calculation that compares weight to height).
  • Being expected to live less than 52 weeks (about one year) according to the doctor’s judgment.
  • Needing emergency medical procedures or showing signs of an unstable condition, such as sudden chest pain, very low blood pressure (systolic < 90 mmHg), severe heart failure (advanced stage), or fluid build‑up in the lungs.
  • Having a possible acute coronary syndrome (a heart problem that could be a heart attack or unstable chest pain that has not been ruled out).
  • Having a complex heart defect that was present from birth (congenital heart disease).
  • Having serious heart valve disease, or a valve problem that is likely to need treatment within the next year.
  • Having an irregular heart rhythm (arrhythmia) or fast heart rate that could make the imaging test poor, especially conditions like atrial fibrillation or frequent extra beats.
  • Having a stent placed inside a coronary (heart) artery.
  • Having a previously implanted pacemaker, internal defibrillator, or a leftover (abandoned) lead from such devices.
  • Having muscle disease (myopathy) or any other known reason why you cannot safely take the study medicines (such as BA, EZE, atorvastatin, or rosuvastatin).
  • Having an artificial heart valve (prosthetic valve).
  • Being allergic to or unable to use the contrast dye or other medicines needed for the imaging test (for example, beta blockers or nitroglycerin).
  • Having taken any experimental or investigational drug within the past 40 days (or five drug half‑lives, whichever is longer) or being enrolled in another interventional study at the same time.
  • Being unable to stay on a stable, high‑intensity triple‑therapy dose for the whole study period.
  • Having a past heart attack (myocardial infarction), stroke, peripheral artery disease (poor blood flow to arms or legs), or having had heart‑artery procedures such as angioplasty (PCI) or bypass surgery (CABG).
  • Having significant narrowing of major heart arteries (e.g., ≥50 % blockage in the left main artery, ≥70 % in the main front artery, or severe blockages in three major vessels) that would require a revascularisation procedure.
  • Having serious liver disease (such as hepatitis B or C) or liver enzyme levels (AST or ALT) more than three times the normal upper limit.
  • Having a history of gout or a uric acid level at screening of 6.8 mg/dL or higher.
  • Having reduced kidney function with an estimated glomerular filtration rate (eGFR) below 40 mL/min/1.73 m², or being on dialysis.
  • Having an active cancer (excluding non‑melanoma skin cancers).
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Investigated drugs

  • Atorvastatin

    is a medication that belongs to the statin class. It works by lowering the amount of “bad” cholesterol (LDL) in the blood. In this study it is used as a high‑intensity statin to help shrink and stabilize the fatty plaques that build up in the coronary arteries.

  • Rosuvastatin

    is another statin that also reduces LDL cholesterol. It is being tested as an alternative high‑intensity statin in the trial, with the same goal of reducing plaque size and making the plaques less likely to cause problems.

  • Bempedoic acid and ezetimibe

    is a combination of two drugs taken together. Bempedoic acid lowers cholesterol by blocking a step in the liver that makes cholesterol, while ezetimibe reduces the amount of cholesterol absorbed from food in the intestine. Together they add extra cholesterol‑lowering power to the statin, and the study looks at how this triple approach affects plaque regression.

What is already known about the treatment

  • ATORVASTATIN

    This medication is taken as an oral tablet, usually 40 mg once daily. It is an approved and widely studied drug used to lower high cholesterol and reduce the risk of heart disease. It works by blocking an enzyme called HMG‑CoA reductase, which the liver needs to make cholesterol. It belongs to the drug class known as HMG‑CoA reductase inhibitors, or statins.

  • ROSUVASTATIN

    This drug is also taken as an oral tablet, typically 20 mg once a day. It is an established, prescription medication for lowering LDL cholesterol and helping prevent cardiovascular problems. Its action is to inhibit the same HMG‑CoA reductase enzyme, decreasing the amount of cholesterol the body produces. It is classified as a statin, which is a type of HMG‑CoA reductase inhibitor.

  • BEMPEDOIC ACID AND EZETIMIBE

    The combination comes as an oral tablet containing both agents, taken once daily at a total dose of about 180 mg. It is a newer, approved therapy that is used when additional cholesterol lowering is needed beyond what statins provide. Bempedoic acid stops an enzyme called ATP‑citrate lyase in the liver, reducing cholesterol creation, while ezetimibe blocks the absorption of cholesterol from food in the intestine. Together they are classified as an ATP‑citrate lyase inhibitor (bempedoic acid) plus a cholesterol absorption inhibitor (ezetimibe).

Investigated diseases

Coronary atherosclerosis - A condition in which fatty deposits build up on the inner walls of the coronary arteries. Over time these deposits, called plaques, become thicker and can harden. As the plaques grow, they narrow the artery and reduce the space for blood to flow. The narrowed arteries may cause the heart muscle to receive less oxygen during activity. The disease typically progresses slowly, with plaque accumulation increasing gradually over many years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524625-41-00Protocol codeDSE-BMP-0005-CIS-MAEstimated enrolment103 patientsSponsorDaiichi Sankyo Europe GmbH

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