RecruitingOBSERVATIONAL

Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease

This study aims to understand the link between a specific type of blood fat, called Lipoprotein(a) or Lp(a), and your body's natural ability to dissolve blood clots. We're focusing on people who have atherosclerosis (narrowed arteries) or issues with their heart's main valve (aortic valve disease). Previous research suggests that problems with breaking down clots can increase your risk of heart attacks and strokes. Until recently, Lp(a) was hard to treat, but new medicines for cholesterol, like PCSK9 inhibitors and inclisiran, can now lower it. This study wants to see if reducing Lp(a) with these new drugs can also help your body dissolve clots more effectively, potentially lowering your risk of serious heart problems.

At a glance

Status

Recruiting

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

180

Start

20 Oct 2023

Estimated completion

01 Oct 2027

Atherosclerosis Aortic Valve Disease

What is this study about?

Imagine your blood has a built-in cleaning crew that helps break down any small clots that might form. This study is looking into how well that cleaning crew works in people who have narrowing of the arteries (atherosclerosis) or problems with their heart's main valve (aortic valve disease). We're particularly interested in a specific fatty substance in your blood called Lipoprotein(a), or Lp(a) for short.

We know that if your body isn't very good at dissolving clots naturally, you might have a higher risk of heart attacks and strokes. Until recently, we didn't have many good ways to lower Lp(a) levels, so it was considered a difficult risk factor to manage. However, new medications that reduce cholesterol, such as PCSK9 inhibitors and inclisiran, have also been found to lower Lp(a) levels by about 20-25%.

So, this study has two main goals: First, we want to see if having a high level of Lp(a) in your blood is connected to how well your body breaks down clots. Second, we want to find out if taking these new cholesterol-lowering medicines (PCSK9 inhibitors or inclisiran) can improve your body's natural ability to dissolve clots. This research is important because if we can find ways to improve clot breakdown, it could help reduce the risk of serious heart problems for many people.

Key takeaways

Tests the link between Lp(a) and how blood clots are broken down.
Focuses on people with heart artery disease or aortic valve problems.
Investigates if new cholesterol drugs (PCSK9 inhibitors, inclisiran) improve clot breakdown.
Aims to find new ways to reduce heart attack and stroke risk.
Participation involves providing blood samples.
You will not be given a new experimental drug, but rather a treatment your doctor has already prescribed.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be suitable if you have a diagnosis of moderate or severe calcific aortic stenosis (a problem with your heart valve) or if your doctor has already decided you'd benefit from treatment with certain cholesterol-lowering medicines (PCSK9 inhibitors or inclisiran).

It's important that you're willing and able to understand the study information and agree to take part. You also need to be prepared to provide blood samples for the tests.

However, you couldn't take part if you're under 18, can't give your consent, or have other serious health conditions like significant problems with your brain, liver, kidneys, or blood that might affect the study results. You also can't participate if you're already in another drug trial or have conditions related to substance abuse or high alcohol consumption.

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?
Has your doctor said you're eligible for PCSK9 inhibitors or inclisiran, OR do you have moderate/severe aortic valve disease?
Are you able to understand the study information and agree to take part?
Are you willing to provide blood samples as required for the study?
Do you have any significant ongoing health issues (other than specified conditions) that might affect the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to provide blood samples for various tests. These tests will help us measure your Lp(a) levels and see how well your blood naturally breaks down clots. You wouldn't be given a new study drug if you're eligible for the part of the study looking at existing medications; instead, the study would observe your response to the PCSK9 inhibitor or inclisiran that your doctor has already decided is right for you. The study aims to understand how these existing treatments affect your body's clot-dissolving abilities over time. The total duration of your involvement would depend on the specific details that your study doctor would explain, including how many visits or blood samples would be needed.

Potential risks and benefits

Taking part in this study may offer the benefit of learning more about your Lp(a) levels and clot-dissolving ability. While you wouldn't receive a new medication, your participation will help doctors understand these conditions better, which could lead to better treatments for others in the future. The main risks involve providing blood samples, which can sometimes cause minor bruising or discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

East and North Herts NHS Trust
Verified postcode
Stevenage, United Kingdom· Recruiting

Common questions

What is Lp(a)?

Lp(a) is a specific type of fatty substance in your blood, similar to 'bad' cholesterol, that can increase your risk of heart disease.

What is fibrinolysis?

Fibrinolysis is your body's natural process of breaking down and dissolving blood clots.

What are PCSK9 inhibitors and inclisiran?

These are newer medications that help to lower cholesterol levels, and importantly for this study, they can also help reduce Lp(a) levels.

Will I have to take new medicine in this study?

No, if you're included, you'd be taking PCSK9 inhibitors or inclisiran because your doctor has already decided they are suitable for you; the study is observing their effects.

How many times will I need to visit the hospital?

The exact number of visits will be explained to you by the study team, but it will involve attending for blood sample collections.

How to find out more

Joshua H Leader, MBChB, BSc

joshua.leader@nhs.net 07376188768 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.