RecruitingPHASE4INTERVENTIONAL

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

This study is looking at the best way to use blood-thinning medicines for people who have an irregular heartbeat called atrial fibrillation (AF) and have also had a stent put into their heart. After a stent, medicines are needed to prevent blood clots, but AF also needs separate blood thinners to prevent strokes. Combining these can increase bleeding risk. Currently, patients often take three blood-thinning medicines for a short time, then two, and finally one. This study is testing if starting with just one type of antiplatelet medicine for a month, then switching to one anticoagulant medicine for longer, is safer regarding bleeding, but still effective at preventing clots and protecting the heart. It's a way to see if using fewer medicines at once could be better for patients.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

3,010

Start

18 Dec 2023

Estimated completion

30 Jun 2028

Percutaneous Coronary Intervention (PCI)Atrial Fibrillation (AF)Oral Anticoagulation P2Y12 Inhibitor

What is this study about?

When people have an irregular heartbeat called atrial fibrillation, they need to take special medicines, often called anticoagulants or 'blood thinners', to help prevent strokes. If these same people also have a procedure to open up blocked heart arteries and have a small tube called a stent put in (this procedure is called PCI), they also need other types of blood-thinning medicines, known as antiplatelets, to stop clots forming in the new stent.

The challenge is that taking several blood-thinning medicines at once, even though they protect against different problems, can increase the risk of bleeding. Doctors are trying to find the safest way to give these medicines so they protect the heart and prevent strokes without causing too many bleeding problems.

Currently, many patients start by taking three blood-thinning medicines for a short period (about a month), then two for several months, and finally just one long-term. This study wants to see if a different approach could be better. Researchers are investigating if giving just one antiplatelet medicine for the first month after the stent, and then switching to just one anticoagulant medicine for the long term, could lead to fewer bleeding complications while still being as effective at preventing heart-related problems. This is an important question because finding the right balance between preventing clots and avoiding bleeding is key for patients' health and wellbeing.

Key takeaways

This study evaluates different blood-thinning medication strategies for people with atrial fibrillation who have received a heart stent.
It aims to find out if using fewer medicines at certain times can reduce bleeding risks while still preventing clots.
Participation involves being randomly assigned to either the current standard treatment or a new 'monotherapy' approach.
Your health and medication will be closely monitored for 12 months.
This research hopes to improve safety and care for patients needing both types of blood thinners.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults aged 18 or over. You would need to have an irregular heartbeat called atrial fibrillation, which needs long-term blood-thinning medication. You must also have recently (within the last 7 days) had a stent successfully put into your heart arteries, and you shouldn't have any further heart artery procedures planned right away. It's important that you haven't had any serious problems since your stent procedure, like new chest pain or a stroke.

There are also some reasons why you wouldn't be able to join. For example, if you have certain heart valve conditions, or if you've recently had a stroke (within the last month). You also can't take part if you have certain severe kidney or liver problems, or if you are unable to take the study medications due to allergies or other health reasons. If you need special treatments for your atrial fibrillation in the near future, like an electrical shock (cardioversion) or a procedure to block faulty heart signals (ablation), you also might not be eligible.

To join the study, you'd need to give your full permission in writing after understanding all the details. The study doctors will carefully check your health history to make sure it's safe and appropriate for you to participate.

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 atrial fibrillation and take blood thinners for it?
Have you had a heart stent inserted successfully within the last 7 days?
Do you have no other heart artery procedures planned immediately?
Do you have no severe kidney or liver problems?
Have you not had a stroke in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will follow the current standard treatment plan, and the other group will try the new approach with fewer blood-thinning medicines. Neither you nor your doctor will get to choose which group you are in.

For the first month after your stent, you will either take a combination of blood thinners (the usual care) or just one type of antiplatelet medicine (the new approach). After this, the medicines will change again. Your treatment will be carefully monitored for a full year from when you join. You'll need to attend regular clinic visits where the study team will carry out checks, assess your health, and review your medication. They will also keep track of any health changes or problems you experience. The total duration of your active participation, including follow-up, will be 12 months.

Potential risks and benefits

Participating in this study might offer you the benefit of close medical monitoring and potentially a treatment strategy that could reduce your risk of bleeding while still protecting your heart. However, there are also potential risks involved, mainly related to blood thinners — either an increased risk of bleeding or, less commonly, the possibility of blood clots. It's important to remember that this study is comparing two different approaches, and neither is guaranteed to be better for every individual. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

Hartcentrum Hasselt
Verified postcode
Hasselt, Belgium· Not yet recruiting
CHU Nîmes
Verified postcode
Nîmes, France· Not yet recruiting
Universitätsklinikum Frankfurt/Main
Verified postcode
Frankfurt am Main, Germany· Not yet recruiting
Klinikum Friedrichshafen
Verified postcode
Friedrichshafen, Germany· Not yet recruiting
Ospedale Ferrarotto
Verified postcode
Catania, Italy· Not yet recruiting
IRCCS Humanitas
Verified postcode
Milan, Italy· Not yet recruiting
UMC public
Verified postcode
Amsterdam, Netherlands· Not yet recruiting
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Verified postcode
Poznan, Poland· Not yet recruiting
Hospital Universitario Marques de Valdecilla
Verified postcode
Santander, Spain· Not yet recruiting
Cardiocentro Ticino Institute
Verified postcode
Lugano, Switzerland· Recruiting
Universitätsspital Basel
Verified postcode
Basel, Switzerland· Recruiting
Inselspital, Bern University Hospital, Department of Cardiology
Verified postcode
Bern, Switzerland· Recruiting

Common questions

What is 'atrial fibrillation'?

It's an irregular and often fast heartbeat that can sometimes increase your risk of stroke.

What is a 'heart stent'?

It's a small mesh tube placed in a narrowed heart artery to keep it open after a procedure to improve blood flow.

Why do I need blood thinners after a stent and for atrial fibrillation?

Blood thinners prevent clots in your stent, and different blood thinners reduce your stroke risk from atrial fibrillation. The study is looking for the best way to combine them.

What does 'monotherapy' mean?

In this study, it means taking only one type of blood-thinning medicine at a time, rather than a combination.

Will I get to choose which treatment I receive?

No, you'll be randomly assigned to one of the treatment groups, like drawing lots, to ensure a fair comparison.

How to find out more

Stephan Windecker, Prof.

Stephan.Windecker@insel.ch +41 31 632 44 97 Official trial record

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