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Triple vs dual therapy with rosuvastatin, ezetimibe and bempedoic acid in patients with atherosclerotic heart disease and high cholesterol undergoing revascularisation

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

People with Peripheral arterial disease, Coronary artery atherosclerotic heart disease and Hypercholesterolaemia often need medicines to lower the amount of “bad” cholesterol in their blood. In this study one group will receive a three‑medicine combination that includes a daily tablet of rosuvastatin, a second tablet of ezetimibe and a third tablet of bempedoic acid. The other group will take only the first two medicines, without the third one.

The purpose of the study is to see which treatment more often gets the level of LDL-C (the laboratory name for bad cholesterol) below 55 mg/dL after about three months. Participants will be checked at the start, after 12 weeks and again after a year. Blood samples will be used to measure the amount of cholesterol‑carrying proteins such as Apo-B100 and Apo-A1, as well as apolipoprotein (a) and a marker of inflammation called hs-CRP. Simple questionnaires will also be given to assess mood using the HADS-D score and to evaluate psychological flexibility.

During the trial participants will take the assigned tablets once each day and attend the three scheduled visits where a nurse or doctor will draw a small amount of blood, ask the questionnaires and check for any side effects. The study will continue for about one year, after which the collected information will be used to compare the two treatment approaches.

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

    Baseline visit (v1)

    You will attend the first study visit after joining the trial. during this visit, basic health information and blood samples will be collected to measure your cholesterol level (ldl‑c), apolipoprotein values, and inflammation marker (hs‑crp). questionnaires about mood and psychological flexibility will also be completed.

    The study team will explain the two possible treatment plans and randomly assign you to either the triple therapy group or the dual therapy group.

  2. Step 2

    Start of medication

    If you are assigned to the triple therapy group, you will begin taking three tablets each day: rosuvastatin 20 mg, ezetimibe 10 mg, and bempedoic acid 180 mg. each tablet is taken by mouth once daily (od), preferably at the same time each day.

    If you are assigned to the dual therapy group, you will take two tablets each day: rosuvastatin 20 mg and ezetimibe 10 mg, also once daily.

  3. Step 3

    Daily medication adherence

    You should swallow the prescribed tablets with water each day, without missing doses. keep a simple log or use a reminder to help you remember to take the medication at the same time every day.

    If you experience any side effects, you must report them to the study staff at the next visit or through the provided reporting form.

  4. Step 4

    12‑week visit (v2)

    After 12 weeks of treatment, you will return for the second study visit. blood will be drawn again to check your ldl‑c level and other laboratory measurements.

    The same questionnaires about depression (hads‑d) and psychological flexibility will be completed to compare changes from the baseline visit.

    The study will evaluate whether your ldl‑c has fallen below 55 mg/dl, which is the primary goal at this time point.

  5. Step 5

    Continuation of treatment to 12 months

    You will continue taking the same medication regimen assigned at the start of the trial for the remainder of the study period, up to 12 months.

    Regular self‑monitoring of any new symptoms or adverse events is recommended, and you should keep the study team informed of any serious problems.

  6. Step 6

    12‑month follow‑up visit

    At approximately 12 months after the baseline visit, you will attend the final study visit. a comprehensive blood test will be performed to measure ldl‑c, apolipoprotein‑b100, apolipoprotein‑a1, apolipoprotein (a), and hs‑crp.

    The same mood and psychological questionnaires will be repeated, and all adverse events that occurred during the year will be recorded.

    The study will compare your results with those of participants in the other treatment group to determine long‑term effectiveness and safety.

Who can join the trial?

7 criteria

  • Age: You must be at least 18 years old and not older than 80 years.
  • You must sign a written informed consent form, which shows you understand the study and agree to take part.
  • You need to have atherosclerotic cardiovascular disease (hardening of the arteries that can affect the heart or legs) and need a procedure called revascularisation (a treatment that restores blood flow).
  • Your blood level of LDL‑C (the “bad” cholesterol) at the screening visit must be in a certain range, depending on any cholesterol‑lowering medicines you are already using: ‑ If you are not on any such medicine, the level must be >130 mg/dL and <170 mg/dL. ‑ If you are on simvastatin 40 mg, atorvastatin 10‑20 mg, or rosuvastatin 10 mg alone, the level must be >70 mg/dL and <110 mg/dL. ‑ If you are on atorvastatin 40 mg or rosuvastatin 20 mg alone, the level must be >55 mg/dL and <100 mg/dL. ‑ If you are on atorvastatin 80 mg once daily or rosuvastatin 40 mg, the level must be >55 mg/dL and <85 mg/dL.
  • When you come for the first study visit (Visit 1), your LDL‑C must be between 55 mg/dL and 100 mg/dL while you are already taking rosuvastatin 20 mg once daily.
  • You must be able to tolerate a statin medicine (a drug that lowers cholesterol). This means you either tolerated the medication during a short “run‑in” period, or if you join the study directly at Visit 1, you must have taken rosuvastatin 20 mg daily for at least 6 weeks without problems.
  • Both men and women can take part in the study.

Who cannot join the trial?

16 criteria

  • Use of the cholesterol medicines ezetimibe, bempedoic acid or a PCSK9 inhibitor within the past 8 weeks, or the drug inclisiran within the past 12 months.
  • Women who could become pregnant and are not using reliable birth control (such as sterilisation, an intrauterine device, a partner who has had a vasectomy, or a history of hysterectomy).
  • Kidney function measured by eGFR (a test that shows how well the kidneys filter blood) that is lower than 30 ml/min/1.73 m².
  • Liver enzymes called AST or ALT that are more than three times the normal upper limit, indicating possible liver problems.
  • Having a history of gout or a recent gout attack (a painful joint condition caused by uric acid crystals).
  • Known intolerance (a bad reaction) to statins, ezetimibe or bempedoic acid.
  • Having homozygous familial hypercholesterolaemia (a rare inherited disease that causes very high cholesterol levels).
  • Fasting triglycerides (a type of fat in the blood) higher than 400 mg/dL.
  • Alcohol abuse, defined as drinking more than 15 alcoholic drinks per week.
  • Participation in another study of an investigational medication or medical device within the last 30 days, except for observational studies that only use continuous glucose monitoring devices.
  • Any condition that would make it difficult to follow the study procedures.
  • Having an active carcinoma (cancer), except for basal cell skin cancer and non‑invasive skin lesions.
  • History or current episode of acute coronary syndrome (a sudden heart problem such as a heart attack).
  • History or current episode of acute limb ischaemia (a sudden loss of blood flow to an arm or leg).
  • History or current episode of acute stroke (a sudden interruption of blood flow to the brain).
  • Being pregnant, planning to become pregnant, or breastfeeding.
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Investigated drugs

  • Rosuvastatin

    is a medication that helps lower the amount of bad cholesterol (LDL‑C) in the blood. In this study, it is taken every day by all participants as part of their regular treatment to reduce the risk of heart problems caused by high cholesterol.

  • Ezetimibe

    works by blocking the absorption of cholesterol from the foods you eat, which also helps lower blood cholesterol levels. In the trial, every participant receives this medicine daily, either alone with rosuvastatin or together with two other drugs, to see how well it helps reach the target cholesterol level.

  • Bempedoic acid

    is a newer drug that reduces the production of cholesterol in the liver. It is added only to the group receiving the triple‑drug regimen, so researchers can compare how well this combination works against the standard two‑drug treatment for lowering cholesterol.

What is already known about the treatment

  • Ezegelan 10 mg-Tabletten

    This medication is taken by mouth as a 10 mg tablet. It is an approved drug that is widely described in medical literature for lowering high cholesterol. It is mainly used to treat hypercholesterolaemia and to reduce the risk of heart disease. It works by blocking the NPC1L1 protein in the intestine, which stops dietary cholesterol from being absorbed, and it belongs to the class of cholesterol absorption inhibitors.

  • Nustendi 180 mg/10 mg film-coated tablets

    This product is an oral film‑coated tablet that delivers 180 mg of bempedoic acid together with 10 mg of ezetimibe. Both ingredients are approved and well studied for use in patients who need additional cholesterol lowering beyond a statin. It is indicated for high cholesterol and for people with atherosclerotic cardiovascular disease. Bempedoic acid reduces cholesterol production by inhibiting the liver enzyme ATP‑citrate lyase, while ezetimibe blocks intestinal cholesterol absorption; together they form a combination lipid‑lowering therapy.

  • Rosuvalan 20 mg-Filmtabletten

    This drug is taken orally as a 20 mg film‑coated tablet. Rosuvastatin is a widely prescribed, well‑documented medication for lowering LDL‑cholesterol. It is used to treat hypercholesterolaemia and to prevent heart attacks and strokes. It works by inhibiting the enzyme HMG‑CoA reductase in the liver, which reduces the body’s production of cholesterol, and it is classified as a statin (HMG‑CoA reductase inhibitor).

Investigated diseases

  • Peripheral arterial disease

    A condition where the arteries in the legs become narrowed or blocked, reducing blood flow. It often starts with a buildup of fatty deposits in the vessel walls. As the blockage grows, the legs may feel tired, cramp, or hurt during walking. Over time, symptoms can appear even at rest. The disease can spread to other peripheral arteries.

  • Coronary artery atherosclerotic heart disease

    A condition where the arteries that supply the heart with blood develop plaque that narrows them. The narrowing reduces the amount of blood that reaches the heart muscle. As the plaque grows, the heart may receive less oxygen during activity. This can cause chest discomfort or shortness of breath. The condition can gradually affect more of the coronary arteries.

  • Hypercholesterolaemia

    A condition where the level of cholesterol in the blood is higher than normal. It usually begins with genetic factors or an unhealthy diet that raises cholesterol. Over time, the excess cholesterol can accumulate on artery walls. This buildup can slowly narrow the vessels. The condition may progress silently for many years.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525917-29-00Protocol codeKMT-2026-01Estimated enrolment160 patientsSponsorMedical University Of Graz

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