Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Effect of Inclisiran, Ezetimibe and Statin Therapy on LDL‑C Levels in Patients with Chronic Coronary Syndrome or Prior Myocardial Infarction

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The trial focuses on people who have Chronic coronary syndrome, meaning they have heart disease that can cause chest pain, and who have either suffered a myocardial infarction (heart attack) or are considered at very high risk for atherosclerotic cardiovascular disease (the build‑up of fatty deposits in blood vessels). The study medication is called inclisiran, which is given as a small injection under the skin and is added to the usual cholesterol‑lowering medicines, a pill called ezetimibe and a class of drugs known as statin.

The purpose of the study is to find out whether adding inclisiran can lower the amount of “bad” cholesterol, known as LDL‑C, and reduce the amount of fatty build‑up, called plaque burden, in the arteries of the heart after one year. LDL‑C is a type of cholesterol that can clog arteries, and plaque is the material that forms inside artery walls and can lead to blockages. To see how the plaque changes, participants will have a special scan called Ultra‑High Resolution Photon‑Counting CT Angiography, which is a detailed X‑ray picture of the heart’s blood vessels.

During the study, participants receive the inclisiran injection at the beginning and then at scheduled times over a 12‑month period while continuing their regular ezetimibe and statin pills. Blood tests are done at the start and after a year to measure LDL‑C levels, and the detailed heart scan is performed at the same two time points to assess any change in plaque. Regular visits are scheduled to monitor safety and collect the needed information.

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

    Enrollment and Baseline Assessments

    You are assigned to the study and provided with information about the trial procedures.

    A blood sample is taken to measure your LDL‑C level, which is the amount of "bad" cholesterol in your blood.

    An ultra‑high resolution photon‑counting CT angiography scan is performed to evaluate the amount of plaque in your coronary arteries.

    Your current medication regimen, which includes a combination of ezetimibe and a statin, is recorded.

  2. Step 2

    First Dose of Inclisiran

    You receive a subcutaneous injection of inclisiran at a dose of 284 mg.

    The injection is administered by a healthcare professional during the baseline visit.

  3. Step 3

    Three‑Month Follow‑Up

    A follow‑up visit is scheduled three months after the first injection.

    A blood sample is taken again to check your LDL‑C level.

    No additional dose of inclisiran is given at this visit; you continue your regular ezetimibe/statin therapy.

  4. Step 4

    Six‑Month Follow‑Up and Second Dose

    Six months after the initial injection, you return for another visit.

    A second subcutaneous injection of inclisiran (284 mg) is administered.

    A blood sample is taken to measure LDL‑C, and you continue your usual ezetimibe/statin medication.

  5. Step 5

    Twelve‑Month Final Assessment

    At twelve months, the final study visit takes place.

    A blood sample is collected to determine the change in LDL‑C level from the start of the study.

    A repeat ultra‑high resolution photon‑counting CT angiography scan is performed to assess any change in total plaque burden in the coronary arteries.

    You receive a final subcutaneous injection of inclisiran (284 mg) according to the study protocol.

Who can join the trial?

9 criteria

  • Participant has given written permission (called informed consent) to join the study.
  • Age must be between 18 and 80 years old.
  • Heart artery imaging (called angiography) must show a narrowing of at least 20% of the artery, or more than 50% if special blood‑flow tests (such as RFR, iFR, DFR, or FFR ≥ 0.80) are normal, and there must be no signs of reduced blood flow to the heart on non‑invasive tests.
  • Must have chronic coronary syndrome (CCS) or a past heart attack (myocardial infarction, MI) caused by a plaque breaking open, and/or have had a procedure to open the artery called PCI (percutaneous coronary intervention).
  • Kidney function must be good enough, measured as a glomerular filtration rate higher than 30 ml/min per 1.73 m².
  • Must already be on stable (at least 4 weeks) and the highest tolerated dose of cholesterol‑lowering medicines, including a statin with or without another drug called ezetimibe, as recommended by heart guidelines.
  • Must have proven intolerance to statins, meaning they cannot tolerate at least two different statins because of side‑effects (such as muscle pain, very high muscle enzyme levels called CPK > 10 times the normal limit, or other problems) that improve when the statin is stopped or lowered.
  • Blood level of low‑density lipoprotein cholesterol (LDL‑C) must be 70 mg/dL or higher at the screening visit.
  • Must be willing to receive the study drug Inclisiran by a tiny injection under the skin (subcutaneous administration) at the first visit, again at 3 months, and then every 6 months.

Who cannot join the trial?

8 criteria

  • Acute coronary syndrome, stroke, or recent artery surgery: You cannot join if you had a heart attack, a stroke, or a major blood‑vessel operation for plaque buildup within the last 4 weeks.
  • Recent use of PCSK9 inhibitors: If you have taken medicines such as evolocumab or alirocumab that lower cholesterol by blocking a protein called PCSK9 within the past 90 days, you are not eligible.
  • Heart failure NYHA class III or IV: This means you have advanced heart failure that makes daily activities very difficult or impossible. Such severe heart failure excludes you.
  • Active liver disease: If you have a current liver problem caused by infection, cancer, or a metabolic disorder, you cannot participate. (Your liver enzymes called AST and ALT must be no more than three times the normal upper limit.)
  • Severe non‑cardiovascular disease: Any serious illness that is not related to the heart or blood vessels and is expected to shorten your life to less than 5 years makes you ineligible.
  • Recent cancer treatment: If you had cancer that required surgery, radiation, or chemotherapy in the past 3 years, you cannot join the study.
  • Pregnant or nursing: Women who are pregnant, trying to become pregnant, or breastfeeding are excluded unless they use reliable birth control for the entire study period.
  • Body mass index (BMI) of 40 or higher: If your weight relative to your height gives a BMI of 40 kg/m² or more, you are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Inclisiran

    is a new type of medicine that works by targeting a specific protein in the liver that normally raises bad cholesterol (LDL‑C). By lowering this protein, Inclisiran helps the body reduce LDL‑C levels. It is given as a small injection under the skin, usually only a few times a year, which makes it convenient for patients who need long‑term cholesterol control.

  • Ezetimibe

    is a pill that blocks the absorption of cholesterol from the foods we eat. By preventing cholesterol from entering the bloodstream through the intestines, it helps lower the total amount of bad cholesterol in the blood. It is taken once a day and is often used together with other cholesterol‑lowering medicines.

  • Statin medication

    (such as atorvastatin, rosuvastatin, or similar drugs) works by slowing down the liver’s production of cholesterol. Statins are taken as a daily tablet and are a standard treatment for lowering LDL‑C and reducing the risk of heart disease. In this trial, the statin is combined with ezetimibe, and both are used together with Inclisiran to see how much additional benefit the new drug provides.

What is already known about the treatment

INCLISIRAN - It is given as a subcutaneous injection, usually a single 284 mg dose administered every six months. The drug is approved and widely reported in medical literature as a treatment to lower LDL‑cholesterol in people with chronic coronary syndrome, a history of heart attack, or very high risk of cardiovascular disease, often added to statin and ezetimibe therapy. It works by using a small piece of RNA to tell liver cells to make less PCSK9 protein, which helps the body remove more “bad” cholesterol from the blood. Inclisiran belongs to the class of small interfering RNA (siRNA) medicines that target gene expression.

Investigated diseases

  • Chronic coronary syndrome

    It is a long‑term condition where the arteries that feed the heart become narrowed by plaque, causing chest discomfort or shortness of breath during activity. The narrowing develops gradually, and symptoms can increase as the blockage grows.

  • Myocardial infarction

    A myocardial infarction, or heart attack, happens when blood flow to part of the heart stops suddenly, leading to damage of the heart muscle. After the event, scar tissue forms and the heart may pump less effectively.

  • Atherosclerotic cardiovascular disease

    This disease is caused by fatty deposits building up in artery walls, which can limit blood flow. When the risk is very high, plaque can accumulate quickly and may lead to blockages in several vessels.

Trial detailsLast updated 5 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526046-28-00Estimated enrolment109 patientsSponsorPoliclinico San Donato S.p.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.