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.
1Initial 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
2Study 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
3Treatment 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
4Study 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
5Health 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 Study?
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 Study?
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)
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.
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.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Austria 
Belgium 
Bulgaria 
Croatia 
Czechia 
Denmark 
Estonia 
Finland 
France 
Greece 
Hungary 
Iceland 
Italy 
Latvia 
Lithuania 
Norway 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
The Netherlands 