Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

This study is looking for men and women between 18 and 80 years old. You might be eligible if you have been diagnosed with early coronary artery disease, meaning your heart arteries are slightly narrowed (less than 50% blocked) by plaque, but you haven't had any major heart problems like a heart attack or stroke.

Your cholesterol levels are also important. We are looking for people whose 'bad' cholesterol (LDL-C) level is 1.4 mmol/L or higher, even if you are already taking the highest dose of statin medication you can tolerate. If you're not currently on statins or not on the highest dose, your LDL-C level requirements might be different.

Participants also need to have certain results from a special heart scan (CCTA) that shows plaque build-up and ensures there isn't a severe block that would need immediate treatment. Importantly, you should be able to take statin medication, and for most participants, you'll need to be on a steady dose of a statin for at least a month before starting the study.

If you join this study, it will last for about 24 months. You will be randomly assigned to receive either the study medicine, inclisiran, or a placebo, both given as injections. Over these two years, you will have several visits to the clinic for medical check-ups, blood tests to monitor your cholesterol and general health, and regular heart scans (CCTA) at the beginning and end of the study to measure changes in plaque.

Before starting the treatment, some participants might need a period to make sure they are on the right and highest dose of their statin medication they can tolerate. You will continue to take your prescribed statin medication throughout the study. The study team will explain the schedule of visits and tests in detail.