A randomized, multicenter, open-label trial comparing the effectiveness of Inclisiran to bempedoic acid on LDL cholesterol (LDL-C) lowering in participants with atherosclerotic cardiovascular disease (VICTORION-CHALLENGE)
The VICTORION-CHALLENGE study is an important research project looking into the effectiveness of two different medications, Inclisiran and Bempedoic acid, for lowering 'bad' cholesterol (LDL-C). This is for people who have already experienced problems with their heart or blood vessels, such as a heart attack or stroke. We're comparing these treatments to see which one works best at reducing cholesterol levels. The main goal is to measure how much LDL-C levels change after around five months (150 days) of treatment. We also want to understand how many people reach specific healthy cholesterol targets. This could help doctors better manage cholesterol for patients in the future.
At a glance
What is this study about?
This study, called VICTORION-CHALLENGE, is looking at two medicines called Inclisiran and Bempedoic acid. These medicines are designed to help lower 'bad' cholesterol, also known as LDL-C. High levels of this type of cholesterol can lead to serious health problems like heart attacks and strokes. This study is for people who have already had such problems with their heart or blood vessels, because managing their cholesterol is especially important.
The main aim of this study is to compare Inclisiran and Bempedoic acid to see which one is more effective at bringing down LDL cholesterol levels. We will be looking at how much cholesterol levels change after about five months (150 days) of treatment. Researchers also want to see how many people in the study reach a healthy target for their cholesterol, which is different depending on how high their risk of heart problems is.
By comparing these two medicines, doctors hope to learn more about the best ways to help people keep their cholesterol healthy. This could lead to better treatments and help prevent future heart and circulation problems for many patients in the UK and worldwide. The study is already using these medicines which are available, to gather more information about how they work in real-world settings.
Key takeaways
- This study compares two cholesterol-lowering medicines: Inclisiran and Bempedoic acid.
- It's for people who have high cholesterol and have had previous heart or blood vessel problems.
- The main goal is to see which medicine is better at reducing 'bad' cholesterol (LDL-C) over five months.
- Researchers will also check how many people reach healthy cholesterol targets.
- Participation involves clinic visits, blood tests, and taking study medication.
- The findings could help doctors choose better treatments for cholesterol management.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part.
Crucially, you must have high cholesterol (hypercholesterolemia) and have already experienced a problem with your heart or blood vessels caused by a build-up of fatty deposits. This often refers to conditions like a heart attack, stroke, or other circulation issues.
There will be other detailed health requirements that your doctor will check to make sure the study is a safe and suitable option 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.
- Are you 18 years old or older?
- Do you have high cholesterol?
- Have you previously had a heart attack, stroke, or other circulation problems caused by fatty deposits?
- Are you willing to attend regular clinic appointments and have blood tests?
- Are you currently taking other cholesterol-lowering medicines like statins or ezetimibe?
What does participation involve?
If you decide to join, you will be given study medication, along with any other cholesterol-lowering medicines you are already taking (like atorvastatin, rosuvastatin, or ezetimibe). You won't know which of the main study medicines (Inclisiran or Bempedoic acid) you are receiving. Over about five months (150 days), you will have regular clinic visits. During these visits, the study team will take blood samples to measure your cholesterol levels and check your overall health. They will also ask you questions about how you are feeling and any changes you notice. You may also be asked to fill out questionnaires about your quality of life and how you feel about your treatment.
Potential risks and benefits
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Common questions
What is 'bad' cholesterol (LDL-C)?
LDL-C is often called 'bad' cholesterol because high levels can cause fatty deposits to build up in your arteries, leading to heart disease and stroke.
What kind of problems with heart or blood vessels mean I could join?
This usually means you've had conditions like a heart attack, a stroke, or other issues where your blood vessels have been narrowed by fatty build-ups.
Are Inclisiran and Bempedoic acid new medicines?
These are medicines that are already available to help lower cholesterol, and this study is gathering more information about how they compare in people with existing heart and circulation problems.
How long will the study last for me?
The main part of the study where we check your cholesterol levels will last about five months, or 150 days.
Will I know which treatment I'm getting?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving Inclisiran or Bempedoic acid.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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