AuthorisedTherapeutic use (Phase IV)Interventional

Short-Term Anticoagulation versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES study.

The ANDES study is researching the best way to prevent blood clots after a heart procedure called Left Atrial Appendage Closure (LAAC). This procedure is often done for people with an irregular heartbeat, known as Atrial Fibrillation, to reduce their risk of stroke. After the device is put in, there's a small chance a clot could form on it. This study is comparing different short-term blood-thinning medications (like Dabigatran, Apixaban, Rivaroxaban, or Edoxaban) and anti-clotting medicines (like Aspirin and Clopidogrel). Researchers want to see which treatment is safest and most effective at stopping these clots within 60 days of the procedure. They will also be checking for other important health events like stroke or bleeding over a longer period.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universite De Laval

Enrolment target

250

Start

03 Feb 2025

Atrial Fibrillation Device thrombosis post-Left Atrial Appendage Closure

What is this study about?

When someone has an irregular heartbeat called Atrial Fibrillation, their heart doesn't pump blood as smoothly as it should. This can lead to blood clots forming in a small pouch in the heart called the Left Atrial Appendage. If these clots travel to the brain, they can cause a stroke. To reduce this risk, some people have a procedure called Left Atrial Appendage Closure (LAAC), where a small device is used to seal off this pouch.

After this device is put in, doctors often prescribe medicines to help prevent blood clots from forming on the device itself. This study, called ANDES, is looking closely at different types of blood-thinning medications to see which ones work best and are safest during the first 60 days after the LAAC procedure. They are comparing newer, stronger blood thinners with a combination of two anti-clotting medicines.

The main goal is to find out which treatment is most effective at stopping clots from forming on the device and to monitor for any side effects like bleeding or stroke. By doing this research, doctors hope to improve care for people who have had this important heart procedure, making it safer and more effective for future patients.

Key takeaways

Compares different blood-thinning medicines after a heart procedure (LAAC).
Aims to prevent blood clots on the heart device.
Specifically for people with an irregular heartbeat (Atrial Fibrillation).
Looks at safety and effectiveness over 60 days and longer.
Involves regular check-ups and heart scans.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of whether they are male or female. The doctors will determine if you are eligible to take part.

To be considered for this study, you must have recently had or be about to have a Left Atrial Appendage Closure (LAAC) procedure. You will also need to be someone who would normally be taking blood-thinning medication after this procedure. The medical team will check other health details to make sure the study is a good fit for you.

Quick self-check

Are you 18 years old or older?
Have you recently had or are you due to have a Left Atrial Appendage Closure (LAAC) procedure?
Are you someone who would normally be prescribed blood-thinning medicine after this procedure?
Are you happy to attend regular appointments and have heart scans if you join the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be given one of the study medications (either a blood thinner like Dabigatran, Apixaban, Rivaroxaban, or Edoxaban; or two anti-clotting medicines like Aspirin and Clopidogrel) for a short period after your LAAC procedure. You'll have regular check-ups, including special heart scans (like a TEE, which is a type of ultrasound) about two months after your procedure to check for blood clots on the device. The study will also involve follow-up appointments and checks for up to five years to monitor your health, including looking for strokes or any bleeding. The total duration of active follow-up will be determined by the study plan, but some checks will extend for several years.

Potential risks and benefits

Participating in this study might help doctors understand the best and safest way to prevent blood clots after a Left Atrial Appendage Closure procedure, which could benefit future patients. While there's no guarantee of direct personal benefit, your health will be closely monitored throughout the study. Potential risks include side effects from the medications, such as bleeding, which is a known risk with blood thinners. There is also a small risk of issues related to the heart scans. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

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Spain

Common questions

What is Atrial Fibrillation?

Atrial Fibrillation is a common heart condition that causes an irregular and often abnormally fast heart rate.

What is Left Atrial Appendage Closure (LAAC)?

It's a procedure where a small device is used to seal off a part of your heart called the Left Atrial Appendage, to reduce the risk of blood clots and stroke for people with Atrial Fibrillation.

Why is this study needed?

Doctors want to find the very best way to prevent blood clots from forming on the device after a LAAC procedure, making it safer and more effective for patients.

Will I know which medicine I'm taking?

This study is comparing different treatments. Your study doctor will explain if you will know which specific medication you are receiving.

How long will I be involved in the study?

You'll have close monitoring for about 60 days after your procedure, with follow-up checks continuing for up to five years.