This study is looking at atherosclerotic cardiovascular disease, a condition in which fatty material builds up in the blood vessels and can lead to heart attack or stroke. The study treatment is inclisiran, given as an injection under the skin, and it is compared with placebo to see whether it can help prevent serious heart and blood vessel events in people at high risk who have not yet had one of these events.
People in the study are assigned by chance to receive either inclisiran or placebo, and neither the participants nor the study team knows which one is given. The study follows participants over time while they receive the injections and are checked regularly for major heart-related problems such as myocardial infarction (heart attack), ischemic stroke (stroke caused by a blocked blood vessel), death from heart disease, or urgent procedures to open blocked heart arteries. The main purpose of the study is to find out whether inclisiran lowers the risk of these serious events better than placebo.
1study treatment begins
You receive one of two study products: inclisiran or placebo. A placebo is a solution that does not contain the active medicine.
If you receive inclisiran, the dose is 300 mg given by subcutaneous injection (an injection under the skin).
If you receive the placebo, you receive 0 mg/1.5 mL by injection in the same way.
The study is double-blind, which means that the treatment assignment is not known during the study.
The study is randomized, which means that the treatment is assigned by chance.
2follow-up during the study
You continue in the study after the injection period and are followed over time so that the study can measure whether a first major heart or blood vessel event occurs.
The events being tracked include cardiovascular death (death from a heart or blood vessel cause), non-fatal heart attack, non-fatal ischemic stroke (a stroke caused by reduced blood flow), and urgent coronary revascularization (an urgent procedure to improve blood flow in the heart arteries).
The study also tracks other outcomes, including the first and repeated occurrence of these events, death from any cause, serious side effects, and side effects that lead to stopping the study treatment.
3study ends
Your participation continues until the study reaches its planned end date.
The estimated study period runs from 2023-10-02 to 2029-04-16.
Who Can Join the Study?
Written informed consent must be signed before any study-related test or check is done. This means the person agrees in writing to take part in the study.
The participant must be a man or woman who is at least 40 years old and younger than 80 years old.
The participant must have an increased risk of a first major heart or blood vessel event, meaning they have not had a prior major atherosclerotic cardiovascular disease (ASCVD) event such as a heart attack or stroke.
The increased risk must be shown by at least one of the following:
Evidence of coronary artery disease on a heart scan: this means a scan has shown narrowing in the heart arteries. The narrowing must be at least 20% but less than 50% in the left main coronary artery, or at least 20% but less than 70% in any other major heart artery.
A coronary artery calcium (CAC) score of 100 or more on a CT scan. A CAC score is a number that shows how much calcium, or hardened plaque, is present in the heart arteries.
A 10-year ASCVD risk of 20% or higher. This means the chance of having a heart or blood vessel event in the next 10 years is high.
An intermediate 10-year ASCVD risk of 7.5% to less than 20%, plus at least 2 risk-enhancing factors. Risk-enhancing factors are other health features that raise the chance of heart disease.
If the participant is already taking lipid-lowering therapy (medicine or treatment that lowers blood fats such as cholesterol), the dose must have been stable for at least 4 weeks before the screening visit.
If the participant is on lipid-lowering therapy, they must be willing to keep taking the same background treatment for the whole study.
The LDL-C level at screening must be 70 mg/dL or higher and less than 190 mg/dL. LDL-C means low-density lipoprotein cholesterol, often called the “bad” cholesterol.
Who Cannot Join the Study?
Any past major heart or blood vessel event, including a heart attack at any time, a stroke caused by a blocked blood vessel at any time, or a recent acute coronary syndrome within the last 12 months. Acute coronary syndrome means a group of serious heart problems caused by reduced blood flow to the heart.
Symptomatic peripheral artery disease, which means narrowed arteries in the arms or legs that cause symptoms, such as pain when walking, or a past procedure to open the arteries, or an amputation done because of artery disease.
Any past or planned revascularization because of poor blood flow. Revascularization means a procedure to open or bypass a blocked blood vessel in the heart or another artery outside the heart.
No signs of coronary atherosclerosis on a heart artery scan within the last 2 years. Coronary atherosclerosis means plaque buildup in the heart arteries.
A coronary artery calcium score of 0 within the last 2 years. This score measures calcium buildup in the heart arteries.
Active liver disease or hepatic dysfunction. Hepatic dysfunction means the liver is not working normally.
Previous, current, or planned treatment with a PCSK9 monoclonal antibody, such as evolocumab or alirocumab. A monoclonal antibody is a type of medicine made to target one specific substance in the body.
Pregnancy or breastfeeding.
Being able to become pregnant unless using a reliable form of birth control during the study and for 6 months after the last study dose.
Inclisiran is the study medicine being tested in this trial. It is given as an injection under the skin and is being evaluated to see whether it can help lower the risk of serious heart and blood vessel problems in people at high risk. The trial is looking at whether inclisiran can better prevent major events such as heart-related death, heart attack, stroke, or the need for urgent treatment to open blocked coronary arteries.
Atherosclerotic Cardiovascular Disease – Atherosclerotic cardiovascular disease is a condition in which fatty deposits build up in the walls of arteries, making them narrower and less flexible. Over time, this buildup can slowly worsen and reduce blood flow to the heart, brain, and other organs. As the disease progresses, it may lead to chest pain, heart attack, or stroke. It often develops gradually over many years and may be present before any symptoms are noticed.
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 
France 
Greece 
Hungary 
Italy 
Latvia 
Lithuania 
Poland 
Portugal 
Romania 
Slovakia 
Spain 
Sweden 
The Netherlands 