Active not recruitingOBSERVATIONAL

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is gathering real-world information about a medicine called bempedoic acid, sometimes given with ezetimibe. It's for adults in the UK who have high cholesterol or a mix of high fats in their blood. Researchers are interested in how well this treatment lowers 'bad' cholesterol (LDL-C) and how it might impact heart health over time. They'll also be looking at any side effects people experience and how the treatment is used in everyday medical practice. This isn't a trial where new treatments are tested; instead, it observes what happens when doctors prescribe these medicines in their usual care.

At a glance

Status

Active not recruiting

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Enrolment target

5,000

Start

15 Jan 2021

Estimated completion

30 Oct 2026

Hypercholesterolemia Mixed Dyslipidemia

What is this study about?

This study is focusing on an existing medication called bempedoic acid, which is sometimes combined with another medicine called ezetimibe. These are used to treat people who have high cholesterol or a mix of high fats in their blood. High cholesterol, especially the 'bad' type known as LDL-C, can increase the risk of heart problems.

The main goal of this study is to see how these medicines work in a practical, day-to-day setting, rather than in a highly controlled research environment. It aims to understand who takes these medicines, how effective they are at lowering cholesterol, and if there are any side effects. Researchers will also be looking at how these treatments might affect someone's overall heart health.

Because this is a 'non-interventional' study, doctors will prescribe these medicines as they usually would, and the study will simply collect information about the patients and their treatment journey. This helps gather valuable insights into how these medications perform in a diverse group of people under normal care conditions, which can be very helpful for future patient care.

Key takeaways

This study observes how an existing cholesterol medicine works in real patients.
It aims to understand the benefits and any side effects of bempedoic acid (with or without ezetimibe).
Participation means your routine medical information will be collected.
You'll receive treatment prescribed by your doctor, not experimental medicine.
The study helps doctors understand patient experiences in everyday care.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have given your written consent to participate. You must have been diagnosed with high cholesterol or mixed dyslipidemia.

The key factor for joining is that your doctor has decided to treat you with bempedoic acid, either on its own or combined with ezetimibe. This decision must be made as part of your normal medical care, not specifically for the study.

There are a few situations where you wouldn't be able to join. For example, if you have health conditions that would make taking bempedoic acid unsafe according to its official prescribing information, or if you are already taking part in another clinical trial where you're actively trying out a new treatment. You also need to have a life expectancy of more than one year.

Quick self-check

Are you 18 years or older?
Do you have high cholesterol or mixed dyslipidaemia?
Has your doctor decided to treat you with bempedoic acid (alone or with ezetimibe)?
Are you not currently part of another clinical trial testing a new treatment?
Do you feel that your life expectancy is more than one year?

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

What does participation involve?

If you join this study, you won't be given any experimental treatments; you'll receive the medication your doctor has already decided is best for you, as part of your standard care. The study will mainly involve your doctors collecting information from your routine visits and medical records.

This would include details about your cholesterol levels before starting the medication, and then how they change over a year, and potentially longer. They'll also note any side effects you experience, changes in other blood markers, and any heart-related events. Information will also be gathered about how often you visit your doctor or hospital, and you might be asked to complete questionnaires about your quality of life.

The total duration of your participation would depend on how long your doctor continues your treatment and how long the study continues to collect follow-up information, typically at least one year.

Potential risks and benefits

This study aims to understand the real-world benefits and risks of an existing treatment. Potential benefits might include gaining a better understanding of how these medications help manage cholesterol and potentially reduce the risk of heart problems in people like you. As you'll be receiving treatment decided by your doctor, not specifically for the study, you'll still be getting care that's appropriate for your condition. Potential risks are generally those associated with the medication itself, such as possible side effects, which your doctor would have discussed with you. You are free to stop participating in the study at any time without affecting your medical care.

Locations (443)

Dr. Armin Öhlinger Kardiologe & innere Medizin
Dornbirn, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
LKH-Univ. Klinikum Graz
Graz, Austria
Medizinische Universität Graz
Graz, Austria
Internist Dr. med. univ. Stefan Moser
Hörsching, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
KABEG Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Konventhospital der Barmherzigen Brüder Linz
Linz, Austria
Ordination Dr. Johannes Föchterle
Linz, Austria
Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
Mattersburg, Austria
Kompetenz-Zentrum Diabetes
Salzburg, Austria
Ordination Universitätsdozent Dr. Alexander Kober
Sankt Aegyd am Neuwalde, Austria

+431 more sites — see the official record for the full list.

Common questions

What is high cholesterol?

High cholesterol means you have too much 'bad' cholesterol (LDL-C) or other fats in your blood, which can increase your risk of heart and blood vessel problems.

What is bempedoic acid?

Bempedoic acid is a medication prescribed by doctors to help lower cholesterol levels in people who need it.

Will I get a new medicine if I join?

No, you will receive the medicine (bempedoic acid, with or without ezetimibe) that your own doctor has already decided is right for your usual care.

What does 'non-interventional' mean?

It means doctors treat you as they normally would; the study just observes and collects information about your treatment and health outcomes.

Can I leave the study at any time?

Yes, you are free to stop participating in the study whenever you want, and this will not affect your medical care.