A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

The study is looking for men and women between the ages of 40 and 79. You would be considered if you are at a higher than average risk of having your first major heart event, such as a heart attack or stroke. This might be because you have some signs of narrowing arteries (blood vessels) or a high score on a risk assessment for heart disease.

Also, your cholesterol levels, specifically your LDL-C (often called 'bad' cholesterol), need to be in a certain range. If you're already taking medicines for cholesterol, you would need to be on a stable dose for at least a month before joining and be willing to continue taking it throughout the study.

You would not be able to join if you've already had a major heart attack or stroke, or if you're planning any heart procedures soon. People with certain liver problems, or who are pregnant, breastfeeding, or planning to use certain other cholesterol medications (called PCSK9 inhibitors) would also be excluded.

If you join this study, you'd be randomly assigned to receive either the study medicine, inclisiran, or a placebo (a dummy medicine). Neither you nor your study doctor would know which one you're getting, which helps make the results fair. Both inclisiran and the placebo are given as injections under the skin.

You would receive your first injection when you start, then another one about three months later. After that, you'd get an injection every six months. The study is designed to run for at least three years for every participant, and it will continue until enough major heart events (like heart attacks or strokes) have occurred in the whole group to allow researchers to draw strong conclusions. This means your total time in the study could be longer than three years.