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Active not recruitingOBSERVATIONAL

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

This study is for adults with high cholesterol who are at risk of heart and blood vessel problems. We're looking at a medicine called inclisiran, which helps lower "bad" cholesterol (LDL-C). Researchers want to see how much this medicine lowers cholesterol in real-world settings, along with other treatments people might be taking. They also want to understand if people continue taking inclisiran as prescribed. This isn't a trial where you get a new, untested drug; it's about observing how inclisiran works for patients in their everyday healthcare, helping doctors understand the best ways to manage cholesterol and prevent serious heart conditions.

At a glance

Status
Active not recruiting
Sponsor
Novartis Pharmaceuticals
Enrolment target
847
Start
12 Sep 2022
Estimated completion
05 Oct 2026

What is this study about?

This study is all about high cholesterol, specifically the "bad" kind, called LDL-C. High levels of LDL-C can lead to serious health issues like heart attacks and strokes. Doctors often prescribe medicines to help lower this cholesterol, and inclisiran is one of them.

The main goal of this study is to see how well inclisiran actually works for people with high cholesterol, especially those who already have or are at high risk of heart and blood vessel disease. We'll be looking at how much their LDL-C levels change after starting inclisiran. The study also wants to understand how easily people stick to their inclisiran treatment alongside any other cholesterol-lowering medicines they might be taking. This is important because medicines only work if you take them as prescribed.

Unlike studies where a new medicine is tested for the first time, this is an "observational study." This means doctors are watching how inclisiran is used in normal doctor's visits and daily life, not in a highly controlled research setting. It helps us understand the true impact of the medicine for patients in the UK.

Key takeaways

  • This study observes how inclisiran works for high cholesterol in real life.
  • It aims to understand how much 'bad' cholesterol (LDL-C) lowers.
  • It also checks if people continue to take the medicine as prescribed.
  • You won't get new medicines; you'll receive inclisiran as part of your usual care.
  • Participation involves sharing information from your regular doctor's visits.
  • The study lasts up to two years, but involves no extra appointments.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and have high cholesterol. You must also have a diagnosis of certain heart or blood vessel diseases (like previous heart attack or stroke) or be at high risk of developing them, or have a specific genetic type of high cholesterol called HeFH.

Crucially, your current cholesterol-lowering medicines should not have brought your LDL-C down to the level your doctor aims for, based on health guidelines. This study is for people whose doctors feel they need to improve their cholesterol treatment, and who are just starting inclisiran as part of their regular care.

You cannot join if you've already had inclisiran before, or if you're currently in another study testing a new medicine. Also, if you've recently switched from another similar cholesterol-lowering injection (called a PCSK9 inhibitor) within the last three months, you wouldn't be able to take part.

Quick self-check
  • Are you 18 years old or older?
  • Do you have high cholesterol and a history of heart/blood vessel problems or high risk for them?
  • Is your 'bad' cholesterol (LDL-C) not at the goal your doctor aims for?
  • Has your doctor decided you need to start inclisiran to help manage your cholesterol?
  • Have you not received inclisiran before?
  • Are you NOT currently taking part in another study testing a new medicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your doctor will enrol you while you begin treatment with inclisiran, which will be prescribed as part of your normal care. You won't be given any experimental medicines; you'll receive inclisiran according to how it's usually prescribed in the UK. Researchers will collect information from your routine doctor visits over a period of up to 24 months (two years). They will look at your cholesterol levels at the start of the study and throughout your treatment. They'll also observe whether you're taking your inclisiran as planned. You'll continue to have your regular appointments and tests as recommended by your doctor, and the study will gather information from these visits. There won't be extra visits or special tests just for the study; it's all about observing your care as it happens.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of how inclisiran works in real-world settings, which can help other patients with high cholesterol in the future. As you would be receiving inclisiran as part of your regular medical care, any potential benefits and risks are those associated with the medicine itself, as discussed with your doctor. There are no new or extra risks from the study itself, because it simply observes your existing treatment. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (40)

  • Novartis Investigative Site
    Feldkirch, Austria
  • Novartis Investigative Site
    Graz, Austria
  • Novartis Investigative Site
    Linz, Austria
  • Novartis Investigative Site
    Sankt Veit im Pongau, Austria
  • Novartis Investigative Site
    Vienna, Austria
  • Novartis Investigative Site
    Vienna, Austria
  • Novartis Investigative Site
    Shenzhen, China
  • Novartis Investigative Site
    Holon, Israel
  • Novartis Investigative Site
    Petah Tikva, Israel
  • Novartis Investigative Site
    Tel Aviv, Israel
  • Novartis Investigative Site
    Kuala Lumpur, Malaysia
  • Novartis Investigative Site
    Kuala Lumpur, Malaysia

+28 more sites — see the official record for the full list.

Common questions

What is inclisiran?

Inclisiran is a medicine given by injection that helps to lower 'bad' cholesterol (LDL-C) in your body.

Will I get inclisiran for free if I join?

No, you will be prescribed inclisiran by your doctor as part of your regular care, just as you would normally receive it. The study watches how it's used.

Do I have to do extra visits for this study?

No, there are no extra study visits. The researchers will gather information from your usual doctor's appointments and tests.

How long will the study last for me?

You could be followed for up to two years, but this just involves collecting information from your routine medical records.

Can I stop being part of the study whenever I want?

Yes, you can decide to stop being part of the study at any time, and it won't affect the medical care you receive.

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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