A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)
Coronary artery disease happens when fatty deposits, known as plaque, build up inside the blood vessels feeding your heart. In early, non-obstructive disease, these deposits do not block blood flow completely, but they still raise future health risks. This clinical trial, called VICTORION-PLAQUE, is testing a medicine called inclisiran. Inclisiran works by helping the liver clear 'bad' LDL cholesterol from the blood. Doctors want to know whether adding inclisiran injections to standard daily statin tablets can stop this fatty build-up from growing, or even help it shrink over two years. Participants will take a standard statin and receive either inclisiran or a dummy injection (placebo). Special heart scans will measure the fat in the arteries at the start and after two years. The goal is to find better ways to protect the heart before serious events happen.
At a glance
What is this study about?
Over time, cholesterol and fatty materials can stick to the walls of the arteries supplying blood to your heart. When these deposits do not yet block blood flow and have not led to a heart attack, doctors call it non-obstructive coronary artery disease. Finding the condition at this early stage provides an important opportunity to protect your heart for the future.
Standard care usually involves taking daily cholesterol tablets called statins. This study is testing an additional medicine called inclisiran. Inclisiran works differently from statins; it is an injection given under the skin only a few times a year. It prompts the liver to remove more bad cholesterol from the bloodstream, aiming to lower cholesterol levels further than statins can achieve alone.
Researchers want to see if this extra reduction in cholesterol can stop fatty plaques from growing, or even help reverse them. Using specialised 3D heart scans (called CT scans), doctors will take detailed pictures of the artery walls over two years. If successful, this treatment could provide a powerful new way to stop heart disease from progressing into serious conditions like heart attacks.
Key takeaways
- Tests whether inclisiran injections can stop or shrink fatty deposits in heart arteries.
- Aimed at adults with early-stage heart disease who have never had a heart attack.
- All participants take a standard daily statin and receive either inclisiran or a dummy injection.
- Uses heart CT scans to measure artery plaques at the start and after two years.
- The study lasts for approximately 24 months.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with early, non-obstructive coronary artery disease. This means tests have shown mild fatty build-up in your heart's arteries, but the vessels are not heavily narrowed or blocked.
To be suitable, you must not have had any previous major heart problems or cardiovascular events, such as a heart attack or a stroke. You must also be able to take standard daily cholesterol tablets, such as atorvastatin or rosuvastatin.
The research team will review your medical notes, run routine blood tests, and check your heart imaging to make sure taking part is appropriate and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have been told you have mild fatty build-up in your heart arteries.
- You have never had a heart attack, stroke, or major heart event.
- You are able to take daily statin tablets.
- You can attend regular clinic appointments and have heart scans over two years.
What does participation involve?
Taking part in the trial lasts for about two years (24 months). During this time, you will take a standard statin tablet every day. You will also receive an injection just under the skin at scheduled clinic appointments. Half of the participants will receive inclisiran, and the other half will receive an inactive dummy injection (placebo). A computer decides which treatment you receive by chance, and neither you nor your study doctor will know which one you are given.
You will visit the clinic regularly for health check-ups, blood pressure measurements, and blood tests to check your cholesterol and overall wellbeing. You will also have a specialised heart CT scan at the start of the study and again at month 24. These scans allow doctors to measure the exact amount of fatty build-up in your arteries and see if it has changed over time.
Potential risks and benefits
Locations (6)
- —UnverifiedHungary
- —UnverifiedIreland
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is inclisiran?
Inclisiran is a modern medicine that helps your liver remove bad cholesterol from your blood. It is given as an injection under the skin a few times a year.
What is a placebo injection?
A placebo looks identical to the real medicine but contains no active ingredients. Comparing inclisiran to a placebo helps researchers prove whether the study drug truly makes a difference.
Will I have to stop taking my regular cholesterol tablets?
No. Everyone in the trial continues to take a standard daily statin tablet, such as atorvastatin or rosuvastatin, alongside the study injection.
What does the heart CT scan involve?
A coronary CT scan is a quick, painless test where you lie still on a flat bed while a doughnut-shaped scanner takes 3D pictures of your heart's blood vessels.
Can I leave the study if I change my mind?
Yes. Joining is entirely your choice. You can step down from the study at any time, for any reason, and your regular medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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