Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease (GENPAD)

This study, called GENPAD, is for people with peripheral arterial disease (PAD), which means their leg arteries are narrowed. Doctors are comparing different ways to use blood-thinning medicines like aspirin, clopidogrel, and rivaroxaban. One approach uses a genetic test to help decide which medicine might be best for you, while the other uses standard treatment. The main goal is to see if the personalised approach is better at preventing serious events like heart attacks, strokes, or problems with your legs over two years. They want to find out if tailoring treatment based on your genes can help stop these issues from happening.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

2,276

Start

13 Dec 2024

Peripheral Arterial Disease

What is this study about?

This study, called GENPAD, is looking at how best to treat a condition called peripheral arterial disease (PAD). If you have PAD, it means the arteries in your legs have become narrowed, often due to a build-up of fatty deposits. This can cause pain when walking and, in more severe cases, can lead to serious problems like heart attacks, strokes, or damage to your legs.

The study wants to find out if using a genetic test to help choose your blood-thinning medication is more effective than the usual way doctors decide on treatment. Blood-thinning medicines, like aspirin, clopidogrel, and rivaroxaban, are very important because they help prevent blood clots that can cause these serious problems. By understanding your unique genetic make-up, doctors hope to pick the anti-clotting medicine that will work best for you personally.

Researchers will be carefully tracking people in the study for two years to see who experiences problems like death, major heart-related issues (like heart attacks or strokes), or serious problems with their limbs. The aim is to discover if this genetic-guided approach can lead to fewer complications and better health for people with PAD.

Key takeaways

Looks at personalised medicine for narrowed leg arteries (PAD).
Compares standard blood-thinning treatment with a gene-guided approach.
Aims to prevent serious events like heart attack, stroke, or leg problems.
Involves existing medications: aspirin, clopidogrel, and rivaroxaban.
Study duration is 24 months (two years).

Who may be eligible?

This study is open to adults aged 18 and older. Both men and women can take part.

To be eligible, you must have been diagnosed with peripheral arterial disease (PAD), which means you have narrowed arteries, typically in your legs.

There will be other medical checks and a review of your health history to make sure the study is right and safe for you. The study team will discuss all the requirements with you if you are interested.

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 diagnosed with peripheral arterial disease (PAD)?
Are you willing to take study medications as prescribed?
Can you attend regular clinic visits for two years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to either the standard treatment group or the group where treatment is guided by a genetic test. This decision is made randomly, like flipping a coin. You would receive one or more of the study medications (aspirin, clopidogrel, or rivaroxaban) as prescribed by the study doctors.

You would have several visits to the study clinic over two years. These visits would involve health checks, blood tests, and discussions about how you are feeling and any side effects you might be having. The researchers will be following your health closely for 24 months to see how you are doing.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if the genetic-guided treatment proves to be more effective than standard care in preventing serious health problems. You would also receive close medical attention and monitoring. However, like all medications, the blood-thinning drugs used in this study have potential side effects, such as an increased risk of bleeding. There's also no guarantee that the new approach will be better for you personally. You are completely 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.

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Unverified
Netherlands

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow, most commonly to your legs, which can cause pain and other problems.

What does 'genotype-guided strategy' mean?

It means doctors use information from your genes (your DNA) to help decide which medication might work best for you.

Are the medications in this study new?

Aspirin, clopidogrel, and rivaroxaban are existing blood-thinning medicines. The study is looking at the best way to use them, particularly with genetic guidance.

How long will I be involved in the study?

If you join, your health will be monitored for a total of two years (24 months).

Will I know which treatment group I am in?

The study team will explain how the treatment groups work. Sometimes participants know, and sometimes they don't, to keep the study fair.