Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of inclisiran to prevent heart attacks and strokes in people with atherosclerotic cardiovascular disease

Fast replyRegistered 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

This study focuses on people with atherosclerotic cardiovascular disease, a condition where arteries become narrowed due to buildup of fatty deposits. The research aims to determine if a medication called inclisiran, when combined with standard treatments (atorvastatin or rosuvastatin), can help prevent heart attacks, strokes, and death related to cardiovascular problems.

The study will test inclisiran, given as an injection under the skin, against placebo while participants continue taking their usual cholesterol-lowering medications. These medications include either atorvastatin (40 mg daily) or rosuvastatin (20 mg or more daily), which belong to a group of drugs called statins that help lower cholesterol levels in the blood.

During the study, which will last for 72 months, participants will receive regular injections of either inclisiran or placebo along with their daily statin medication. The researchers will monitor participants to see if the combination of treatments helps prevent serious cardiovascular events like heart attacks and strokes.

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

    Initial medication phase

    You will be taking a high-intensity statin medication (either atorvastatin 40 mg or more daily, or rosuvastatin 20 mg or more daily) for at least 4 weeks before starting the next phase

    Your cholesterol levels will be checked to confirm that your LDL cholesterol (bad cholesterol) is at least 70 mg/dL

  2. Step 2

    Study medication assignment

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

    The assignment is done randomly by computer, and neither you nor your doctor will know which treatment you receive

    You will continue taking your regular statin medication throughout the study

  3. Step 3

    Treatment administration

    Inclisiran or placebo will be given as an injection under the skin (subcutaneous injection)

    You will continue taking your daily statin medication by mouth as prescribed

  4. Step 4

    Study duration

    The study will continue until October 2027

    During this time, your heart health will be monitored regularly

    Medical staff will track any cardiovascular events such as heart problems or stroke

  5. Step 5

    Health monitoring

    Regular check-ups will be scheduled to monitor your health

    Your cholesterol levels will be measured periodically

    Any side effects or health changes will be recorded and evaluated

Who can join the trial?

9 criteria

  • Age 40 years or older, both men and women can participate
  • Must have a fasting LDL cholesterol level of at least 70 mg/dL (also known as "bad" cholesterol) when screened for the study
  • Must be taking stable cholesterol-lowering medications for at least 4 weeks before screening, including:
    • High-dose statin therapy (either atorvastatin 40mg or more daily, or rosuvastatin 20mg or more daily)
    • May also be taking other cholesterol medications like ezetimibe
    • Must have at least one of these previous heart or blood vessel conditions:
      • Heart attack
      • Ischemic stroke (stroke caused by blocked blood vessels)
      • Peripheral arterial disease (PAD) with symptoms such as:
        • Leg pain while walking with reduced blood flow to legs
        • Previous surgery to improve blood flow in legs
        • Amputation due to blocked arteries

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Known allergy or hypersensitivity to inclisiran or its components
  • Severe liver disease (a condition that significantly affects liver function)
  • Uncontrolled high blood pressure (blood pressure consistently above 180/110 mmHg)
  • Major surgery within 3 months before the study
  • Heart attack or stroke within 3 months before the study
  • Severe kidney disease requiring dialysis (a treatment that filters blood when kidneys don't work properly)
  • LDL cholesterol levels below 70 mg/dL (1.8 mmol/L)
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Active cancer or cancer treatment within the past 5 years
  • History of severe allergic reactions to injectable medications
  • Unstable heart conditions (including unstable chest pain or heart rhythm problems)
  • Active substance abuse or alcohol dependency
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 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 medication designed to help reduce cholesterol levels in the blood. It works by decreasing the production of a protein that prevents the liver from removing LDL (bad) cholesterol from the bloodstream. This medication is being studied for patients who have established cardiovascular disease and high cholesterol levels. It is given as an injection and aims to lower the risk of serious cardiovascular events like heart attacks and strokes.

What is already known about the treatment

Inclisiran - A novel injectable medication administered subcutaneously that belongs to the class of small interfering RNA therapeutics, specifically designed to reduce LDL cholesterol levels in patients with atherosclerotic cardiovascular disease (ASCVD). The drug works by blocking the production of PCSK9 protein in liver cells, which leads to increased removal of LDL cholesterol from the bloodstream. Currently being studied in clinical trials for its potential to reduce major adverse cardiovascular events, inclisiran represents a significant advancement in cardiovascular medicine with its unique twice-yearly dosing schedule, offering a new approach to managing high cholesterol in patients with established cardiovascular disease.

Investigated diseases

  • Atherosclerotic Cardiovascular Disease (ASCVD)

    A condition where fatty deposits (plaque) build up inside the arteries, causing them to narrow and harden over time. The plaque consists of fat, cholesterol, calcium, and other substances found in the blood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The disease typically develops gradually over many years and can affect arteries throughout the body. The buildup of plaque can lead to reduced blood flow to the heart, brain, and other vital organs. This progressive condition can affect multiple arteries simultaneously, including those supplying the heart (coronary arteries), brain (cerebral arteries), and limbs (peripheral arteries).

  • Myocardial Infarction

    A condition where part of the heart muscle is damaged due to insufficient blood flow to the heart. The reduced blood flow is typically caused by a blockage in one or more coronary arteries. The affected heart muscle begins to die due to lack of oxygen and nutrients. The damage can occur within minutes of blocked blood flow and may affect the heart's ability to pump effectively.

  • Ischemic Stroke

    A condition where blood flow to a part of the brain is blocked, typically by a blood clot. When brain tissue is deprived of oxygen and nutrients, brain cells begin to die within minutes. The effects of the stroke depend on which area of the brain is affected and how much brain tissue is involved. The blockage can be caused by a clot that forms in the brain's blood vessels or by one that travels from another part of the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510735-21-00Protocol codeCKJX839B12302Estimated enrolment17 007 patientsSponsorNovartis Pharma AG

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).