Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Lowering of LDL-C with rosuvastatin or single-pill combination rosuvastatin/ezetimibe in high/very high-risk patients with hyperlipidaemia – LEASH

This research, called 'LEASH', explores how effectively two different treatments, Sorvasta and Sorvitimb, can reduce high cholesterol levels in adults. Specifically, it focuses on lowering 'bad' cholesterol, known as LDL-C, in individuals who are at a higher risk of developing heart and blood vessel problems. The study aims to find out what percentage of patients achieve their recommended cholesterol goals after 12 weeks of taking these medicines. Doctors set these goals based on an individual's risk level, for example, lowering LDL-C by at least half and reaching a specific low level. This trial also looks at other cholesterol markers and how well people stick to their treatment plan over time.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

KRKA tovarna zdravil d.d. Novo mesto

Enrolment target

195

Start

03 Jun 2024

Hyperlipidaemia

What is this study about?

This study, known as LEASH, is investigating medicines designed to lower high cholesterol. High cholesterol, especially too much 'bad' cholesterol (LDL-C), can increase your risk of heart attacks and strokes. This trial is particularly focused on people who already have high cholesterol and are considered to be at high or very high risk of these heart and blood vessel problems. The aim is to see how well these medications can help patients reach their ideal cholesterol levels.

The main treatments being studied are Sorvasta (which contains rosuvastatin) and Sorvitimb (a combination of rosuvastatin and ezetimibe). Rosuvastatin is a type of medicine called a statin, which helps your body produce less cholesterol. Ezetimibe works by reducing the amount of cholesterol your body absorbs from food. By combining these, doctors hope to achieve even better cholesterol lowering.

The researchers will closely monitor participants for 12 weeks to see if their 'bad' cholesterol (LDL-C) falls to the target levels set for their individual risk. They will also look at how these medicines affect other types of cholesterol and how consistently people take their medication. This kind of research helps doctors understand the best ways to manage cholesterol and reduce the risk of serious health issues for patients.

Key takeaways

This study investigates two medicines for lowering high cholesterol (LDL-C).
It's for adults at high or very high risk of heart problems.
The study measures how well medicines reduce cholesterol to target levels over 12 weeks.
Participation involves taking medication and attending clinic visits for health checks and blood tests.
Goals include lowering 'bad' cholesterol by at least 50% and to specific low levels.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years or older, with no upper age limit. Both men and women can take part.

You would be suitable if you have high cholesterol, specifically if your doctor has identified you as being at high or very high risk of heart or circulation problems. This study is designed for people who need to lower their 'bad' cholesterol (LDL-C) to meet specific health targets.

More detailed checks will be done by the study team to make sure it's safe and appropriate for you to join. This includes reviewing your medical history and other current medications.

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?
Have you been told you have high cholesterol?
Are you considered at high or very high risk of heart problems by your doctor?
Are you able to attend clinic visits regularly for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to take either Sorvasta or Sorvitimb tablets. You will have several visits to the clinic over a 12-week period. At these visits, the study team will take blood samples to measure your cholesterol levels, and they will check how you are feeling and if you are having any side effects. You will be asked to take your medication as prescribed and keep records of when you take it.

The first visit will establish your baseline health and cholesterol levels. After that, you will have follow-up visits at 4 weeks, 8 weeks, and 12 weeks. At each visit, your progress will be assessed, and adjustments might be made if necessary, though the primary focus is on the impact over 12 weeks. Your total participation in the main part of the study will last approximately 12 weeks.

Potential risks and benefits

Taking part in this study might offer you benefits, such as receiving close medical monitoring of your cholesterol levels and access to medication aimed at reducing your risk of heart problems. However, like all medicines, the study drugs may have side effects, which the study team will discuss with you. These could include muscle pain, headache, and stomach upset, among others. There's also the normal risk associated with blood tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovenia
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Unverified
Poland
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Unverified
Germany
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Unverified
Hungary
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Unverified
Croatia

Common questions

What is 'bad' cholesterol (LDL-C)?

LDL-C is a type of cholesterol that, when too high, can build up in your arteries and increase your risk of heart disease and stroke.

Why is it important to lower cholesterol?

Lowering high cholesterol helps to reduce your risk of serious heart and blood vessel problems, such as heart attacks and strokes.

What is the difference between Sorvasta and Sorvitimb?

Sorvasta contains a single medicine called rosuvastatin. Sorvitimb is a combination pill that contains both rosuvastatin and another medicine called ezetimibe, which work together to lower cholesterol.

How long does the study last?

The main part of the study where your cholesterol levels are carefully monitored will last for 12 weeks.

Will I know which medication I'm taking?

The study design will determine if you know which specific medication you are taking. The study team will explain this to you during the consent process.