Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Escalated single Platelet Inhibition for one month plus Direct oral anticoagulation in patients with Atrial fibrillation and acUte coRonary syndrome undergoing percutaneoUS coronary intervention (EPIDAURUS)

The EPIDAURUS study is for adults in the UK who have an irregular heartbeat called atrial fibrillation and have recently had a heart attack. Doctors are looking at whether giving different combinations of blood-thinning medicines can protect these patients from future serious problems like another heart attack, a stroke, or clots in the heart's blood vessels. They are comparing newer, stronger blood thinners like Prasugrel, Clopidogrel, Ticagrelor, and Aspirin. The main goal is to see which treatment works best to prevent these problems, while also making sure it doesn't cause too much bleeding. They will check on patients closely for about six weeks after starting treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

1,474

Start

11 Oct 2024

What is this study about?

The EPIDAURUS study is designed for people who have two important heart conditions at the same time: an irregular heartbeat called atrial fibrillation, and who have also recently experienced a type of heart attack. When someone has a heart attack, doctors often need to open up blocked heart arteries using a procedure called PCI. After this, medicines are usually given to prevent new clots from forming.

Because patients in this study have both atrial fibrillation and have had a heart attack, they are at a higher risk of developing blood clots. These clots can lead to serious problems like another heart attack, a stroke, or even blockage of the stents placed in their heart arteries. This study aims to find the best way to prevent these dangerous clots from forming.

Doctors are comparing different types of common blood-thinning medicines, including Prasugrel, Clopidogrel, Ticagrelor, and Aspirin. They want to see which combination is most effective at stopping these serious events, but also to make sure that the medicines don't cause too much bleeding, which can be a side effect of blood thinners. This research is important to help doctors know how to give the best and safest care to people with these complex heart problems.

Key takeaways

This study is for people with both an irregular heartbeat (atrial fibrillation) and a recent heart attack.
It aims to find the best blood thinner combination to prevent future heart problems and strokes.
Researchers are also carefully watching for any serious bleeding.
The study involves well-known blood-thinning medications.
Your health will be closely monitored for about six weeks, with a final check at six months.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To be considered, you must have an irregular heartbeat called atrial fibrillation.

Additionally, you must have recently had a specific type of heart attack. This includes heart attacks where changes are seen on an ECG test (called STEMI) or other types of heart attacks that show up in blood tests (called NSTEMI or biomarker-positive acute coronary syndrome).

Finally, you need to have recently undergone a procedure to open up blocked heart arteries, known as a PCI (Percutaneous Coronary Intervention). If you meet all these criteria, you might be able to take part.

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?
Do you have an irregular heartbeat called atrial fibrillation?
Have you recently had a heart attack (STEMI or NSTEMI)?
Have you recently had a procedure called PCI (to open heart arteries)?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive one of the specific combinations of blood-thinning medicines being tested. You will have regular check-ups with the study team for about six weeks after you start the treatment. During these visits, the team will monitor your health closely, check for any side effects, and see how well the treatment is working. They will specifically look for serious events like another heart attack, stroke, or severe bleeding. There will also be a follow-up at six months to check on your overall health.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving closely monitored care with medicines chosen to prevent serious heart problems. The potential risks involve side effects from the blood-thinning medications, mainly bleeding. While the study aims to find the safest and most effective treatment, there is always a chance of side effects, including serious bleeding. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your routine medical care.

Locations (2)

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

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Unverified
Austria
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Unverified
Germany

Common questions

What is atrial fibrillation?

It's a common heart condition that causes an irregular and often fast heart rate, which can lead to problems like strokes.

What is a PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a tiny balloon or stent to open up blocked heart arteries, often done after a heart attack.

What kind of medicines are being tested?

The study is looking at different combinations of common blood-thinning medicines, such as Prasugrel, Clopidogrel, Ticagrelor, and Aspirin. These help prevent blood clots.

How long will I be involved in the study?

You'll be closely monitored for about six weeks, with a final check-up around six months after starting treatment.

Will I know which treatment I'm receiving?

The study's design means you might not immediately know which specific medication combination you are getting, as this helps ensure the study results are fair and accurate.