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Early LDL‑cholesterol reduction with rosuvastatin drug combination in patients with acute coronary syndrome

Verified siteFast replyRegistered drugNo placebo
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What is this trial about?

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

The trial focuses on patients who have experienced Acute Coronary Syndrome, a sudden heart problem that can cause chest pain or a heart attack. The study tests several medicines that lower cholesterol, including a pill called rosuvastatin, another pill named atorvastatin, a tablet of bempedoic acid, a tablet of ezetimibe, and three injectable drugs: alirocumab, evolocumab, and inclisiran. Cholesterol is measured as LDL‑C, often called “bad cholesterol,” and the goal of the medicines is to reduce this level quickly after the heart event.

The purpose of the study is to see whether an early “treat‑to‑target” approach, which aims for a specific low cholesterol level, works better than the usual guideline‑based treatment. Participants are randomly assigned to receive either the treat‑to‑target plan or the standard plan, start the medication soon after their heart problem, and have blood tests at about 6 weeks, 6 months, and 12 months to check cholesterol levels and safety. The study follows each person for up to a year to observe how well the cholesterol targets are met and to monitor any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    After you join the study, the research team will assign you to one of the treatment groups using a process called randomization. This means that the assignment is made by chance, so you will not know in advance which specific medicines you will receive.

    The study has two types of groups: a test group that receives a combination of newer cholesterol‑lowering drugs, and a comparator group that receives standard medicines recommended in current guidelines.

  2. Step 2

    Baseline Assessments

    Before starting any medication, you will undergo a series of baseline assessments. These include a blood draw to measure your LDL‑C (the “bad” cholesterol) level, as well as other blood tests for high‑density lipoprotein cholesterol, triglycerides, Lipoprotein(a), apolipoprotein B, and high‑sensitivity C‑reactive protein.

    A brief medical evaluation will also be performed to confirm that you meet the study criteria for acute coronary syndrome (ACS) and to record any existing health conditions.

  3. Step 3

    Start of Medication Regimen

    You will begin taking the medicines assigned to your group. All oral tablets are taken once daily:

    Rosuvastatin 40 mg taken by mouth each day (test group);

    Atorvastatin 80 mg taken by mouth each day (comparator group);

    Bempedoic acid 180 mg taken by mouth each day (test group);

    Ezetimibe 10 mg taken by mouth each day (comparator group).

    In addition, you will receive subcutaneous injections (injections under the skin) administered by study staff according to the study schedule:

    Alirocumab 10.7 mg injection (test group);

    Evolocumab 10 mg injection (test group);

    Inclisiran 1.5 mg injection (test group).

    The injections are given at the clinic on the dates specified by the study protocol. You will be instructed on any additional doses that may be required during the trial.

  4. Step 4

    First Follow‑Up Visit (6 Weeks)

    Six weeks after you start the medication, you will return to the clinic for the first follow‑up visit.

    During this visit, another blood sample will be taken to measure your LDL‑C level and the other lipid parameters.

    The study will check whether you have reached the target of an LDL‑C level below 55 mg/dL (or below 40 mg/dL if you experience another heart problem) and whether your LDL‑C has dropped by more than 50 % from the baseline value.

    Any side effects or adverse events you have experienced will be recorded.

  5. Step 5

    Continued Medication and Monitoring

    You will continue taking the daily oral tablets exactly as prescribed.

    If additional subcutaneous injections are scheduled after the 6‑week visit, you will receive them at the clinic according to the study timetable.

    You should report any new symptoms, side effects, or health changes to the study staff promptly.

  6. Step 6

    Second Follow‑Up Visit (6 Months)

    At the 6‑month mark, you will have another clinic visit.

    Blood tests will again be performed to assess LDL‑C, high‑density lipoprotein cholesterol, triglycerides, Lipoprotein(a), apolipoprotein B, and high‑sensitivity C‑reactive protein.

    The study will evaluate whether you continue to meet the LDL‑C target and the >50 % reduction goal.

    Safety will be reviewed by recording any adverse events or serious adverse events that have occurred since the start of the trial.

  7. Step 7

    Third Follow‑Up Visit (12 Months)

    Twelve months after randomization, you will attend the final study visit.

    A comprehensive set of blood tests will be repeated to measure all lipid and inflammatory markers.

    The final assessment will determine the proportion of participants who achieved the LDL‑C targets at 12 months and will document any adverse events that occurred during the entire study period.

    After this visit, the study medication will be discontinued unless your regular physician prescribes continued therapy.

  8. Step 8

    Study Completion

    Once the 12‑month assessments are finished, the trial is considered complete for you.

    All collected data will be used to evaluate the effectiveness and safety of the treatment strategies.

    You will receive a summary of your individual results if you request it from the study team.

Who can join the trial?

4 criteria

  • Be at least 18 years old, and you can be male or female.
  • Have been diagnosed with an acute heart problem called ST-elevation acute coronary syndrome (ACS) or non‑ST‑elevation ACS. These terms describe two different patterns that doctors see on an electrocardiogram (a test that records the heart’s electrical activity).
  • Have a starting (or baseline) level of LDL cholesterol (LDL‑C) that is:
    • at least 55 mg/dL (which equals 1.4 mmol/L) if this is your first heart event, or
    • at least 40 mg/dL (which equals 1.0 mmol/L) if you have had a previous heart‑related blockage.

Who cannot join the trial?

12 criteria

  • You cannot take part if you have a known allergy or any reason why you must not use the cholesterol‑lowering medicines being studied (such as high‑dose statins, ezetimibe, PCSK9 inhibitors like evolocumab, alirocumab, inclisiran, or bempedoic acid). This is called a contraindication, which means the drug could be unsafe for you.
  • You cannot take part if you are using drug combinations that are not allowed, for example bempedoic acid together with simvastatin above 40 mg per day, atorvastatin together with glecaprevir/pibrentasvir, or rosuvastatin if you have muscle problems (myopathy) or are also taking cyclosporine, or rosuvastatin 40 mg per day if you have risk factors for muscle breakdown (rhabdomyolysis).
  • You cannot take part if you have used systemic steroids or systemic cyclosporine (strong anti‑inflammatory or immune‑suppressing medicines) in the past three months.
  • You cannot take part if your doctor believes you are unlikely to live more than one year (limited life expectancy).
  • You cannot take part if you are pregnant, breastfeeding, or could become pregnant and are not willing to use highly effective birth control during the study.
  • You cannot take part if you are already taking the highest dose of a statin that you can tolerate together with ezetimibe.
  • You cannot take part if you are already receiving a PCSK9 inhibitor.
  • You cannot take part if your heart condition is unstable, meaning you have uncontrolled blood‑pressure problems (hemodynamic instability) or irregular heart rhythm (electrical instability).
  • You cannot take part if you have severe kidney problems, defined as an estimated glomerular filtration rate (a measure of kidney function) less than 30 ml/min/1.73 m².
  • You cannot take part if you have active liver disease or a history of liver problems, or if your liver enzymes (AST or ALT) are more than three times the normal upper limit.
  • You cannot take part if you have been in another clinical trial that gave an experimental drug within the past 30 days, or within five drug‑clearance periods of that drug (whichever is longer).
  • You cannot take part if you have used a cholesterol ester transfer protein (CETP) inhibitor in the past year.
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Investigated drugs

  • Rosuvastatin

    is an oral medication that belongs to the statin family. It works by blocking a step in the liver that makes cholesterol, which helps lower the “bad” LDL‑cholesterol in the blood. In this trial rosuvastatin is used as a standard (comparator) treatment based on current heart‑disease guidelines, so its effect can be compared with newer approaches.

  • Atorvastatin

    is another oral statin that reduces cholesterol production in the liver, lowering LDL‑cholesterol levels. In the study atorvastatin is also used as a comparator, representing the usual care recommended for patients after an acute coronary event.

  • Bempedoic acid

    is an oral drug that blocks a different step in the cholesterol‑making pathway than statins. It can lower LDL‑cholesterol even when statins are not enough or not fully tolerated. In the trial bempedoic acid is tested as a new therapy to see if it can quickly reduce LDL‑cholesterol when added early after a heart attack.

  • Alirocumab

    is given by a subcutaneous injection and belongs to a class called PCSK9 inhibitors. It works by preventing a protein (PCSK9) from destroying receptors that remove LDL‑cholesterol from the blood, leading to a strong drop in LDL levels. Alirocumab is being tested as a potential early‑use treatment to see if it improves cholesterol control compared with standard care.

  • Ezetimibe

    is an oral medication that stops the intestine from absorbing cholesterol from food. By reducing the amount of cholesterol that enters the bloodstream, it helps lower LDL‑cholesterol. In the study ezetimibe serves as a comparator, representing a commonly added drug to statin therapy.

  • Evolocumab

    is an injectable PCSK9 inhibitor, similar to alirocumab, that increases the number of LDL‑cholesterol receptors on liver cells, allowing more LDL to be cleared from the blood. It is being evaluated as a test therapy to determine whether early use after a heart event can achieve faster LDL reduction.

What is already known about the treatment

  • Rosuvastatin

    This medication is taken as an oral tablet and is widely approved and used worldwide to lower cholesterol. It belongs to the statin class and works by blocking an enzyme called HMG‑CoA reductase, which reduces the production of LDL‑cholesterol in the liver. Doctors prescribe it for high cholesterol and to help prevent heart attacks and strokes. It is a well‑studied drug with many years of safety and effectiveness data in medical literature.

  • Atorvastatin

    Given as an oral tablet, atorvastatin is an established statin that is approved for treating high cholesterol. It inhibits the same HMG‑CoA reductase enzyme, lowering the amount of LDL‑cholesterol made by the liver. It is used to lower cholesterol levels and reduce the risk of cardiovascular events such as heart attacks. The drug has a long record of use and is supported by extensive clinical research.

  • Bempedoic acid

    This drug is taken as an oral tablet and is approved for use in adults who need additional LDL‑cholesterol lowering when statins are not enough. It belongs to the ATP‑citrate lyase inhibitor class and works by blocking a step earlier than statins in the cholesterol‑making pathway, leading to lower LDL levels. It is prescribed for high cholesterol, especially in patients who cannot tolerate high‑dose statins. Clinical studies have shown it to be effective and safe for long‑term cholesterol management.

  • Alirocumab

    Administered as a subcutaneous injection, alirocumab is an approved medication that belongs to the PCSK9 inhibitor class. It works by attaching to the PCSK9 protein, preventing it from destroying LDL receptors, which allows the liver to clear more LDL‑cholesterol from the blood. It is used for people with very high cholesterol, including those with familial hypercholesterolemia. The drug has been studied in many trials and is considered safe and effective for lowering LDL.

  • Ezetimibe

    This medication comes as an oral tablet and is approved to lower cholesterol by blocking the absorption of dietary cholesterol in the intestine. It is classified as a cholesterol absorption inhibitor and reduces the amount of LDL‑cholesterol that enters the bloodstream. It is commonly used for high cholesterol, often together with a statin for added effect. Ezetimibe has been widely studied and is recognized as safe for long‑term use.

  • Evolocumab

    Given as a subcutaneous injection, evolocumab is an approved PCSK9 inhibitor that helps lower LDL‑cholesterol. It binds to the PCSK9 protein, keeping LDL receptors on liver cells active so they can remove more LDL from the blood. It is prescribed for people with very high cholesterol, including those with genetic conditions. The medication is supported by extensive trial data showing strong LDL‑lowering and good safety.

Investigated diseases

Acute Coronary Syndrome - Acute Coronary Syndrome is a group of conditions caused by a sudden reduction of blood flow to the heart muscle. It includes heart attack and unstable angina. The reduced blood supply can damage heart cells and cause chest pain, shortness of breath, or other symptoms. If the blockage persists, the affected area of the heart may become larger and the symptoms can become more frequent. The condition often develops after a buildup of fatty deposits in the coronary arteries becomes unstable.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-527896-27-00Protocol codeEARLY StudyEstimated enrolment372 patientsSponsorAzienda Ospedaliera Universitaria Federico II Di Napoli

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