Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial

This research is investigating the best way to prevent strokes in individuals who have undergone a heart procedure called catheter ablation for atrial fibrillation, which is an irregular and often too-fast heartbeat. The study will compare two different types of blood-thinning medications: one is a low-dose aspirin, and the other is a newer blood thinner called Xarelto. The main goal is to see how effective these medications are at preventing all kinds of strokes, including those that might not cause obvious symptoms but can be seen on brain scans. Researchers will also be looking at the risk of bleeding, which is a common side effect of blood thinners, as well as how these treatments affect overall health and quality of life. This is an important study to help doctors decide the best treatment plan for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

University Of Ottawa Heart Institute

Enrolment target

282

Start

19 Nov 2024

Risk of stroke by Atrial Fibrillation

What is this study about?

This study is about people who have a condition called atrial fibrillation, also known as AFib. AFib is when your heart beats with an irregular or very fast rhythm, which can increase your risk of having a stroke. Many people with AFib have a treatment called catheter ablation, which is a procedure to correct the irregular heart rhythm.

After a catheter ablation, it's very important to keep taking blood-thinning medications to prevent strokes. This study wants to find out which blood-thinning medication works best to prevent strokes after this procedure, while also making sure the risks, such as bleeding, are kept to a minimum. Researchers are comparing a common blood thinner (aspirin) with a newer one (Xarelto).

The main thing the doctors will be looking for is how well these medicines prevent strokes. This includes not just strokes that cause obvious symptoms, but also very small 'covert' strokes that might not cause symptoms but can be seen on special brain scans. They will also be carefully checking for any side effects like bleeding, and how the medications affect patients' quality of life. This research is important because it will help doctors make the best choices for their patients after a catheter ablation.

Key takeaways

This study compares two blood thinners for stroke prevention after an AFib ablation.
It aims to find the safest and most effective medication.
Researchers are looking at all types of strokes, even those without obvious symptoms.
The study also assesses bleeding risks and impact on quality of life.
Participation involves taking medication, regular check-ups, and brain scans.

Who may be eligible?

To take part in this study, you would need to be an adult, 18 years old or older. The study is open to both men and women. There isn't an upper age limit mentioned, so older adults could also be considered.

The most important requirement is that you have atrial fibrillation and have recently had, or are about to have, a catheter ablation procedure for it. You would also need to meet certain other health criteria which the study doctors would review carefully to make sure the study is right and safe for you.

It's important to remember that not everyone who meets these basic criteria will be able to join. The study team will look at your full health history to ensure you fit all the safety and study requirements.

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 of age or older?
Do you have atrial fibrillation (AFib)?
Have you recently had, or are you scheduled to have, a catheter ablation procedure for AFib?
Are you comfortable taking a blood-thinning medication as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to receive one of two blood-thinning medications. You would take this medication as prescribed throughout the study period. You would need to attend several appointments for check-ups, which would involve physical examinations, blood tests, and special brain scans called MRI scans at the beginning and end of the study to look for any changes. You might also be asked to complete questionnaires about your quality of life and undergo some simple tests of your memory and thinking skills. The study would involve regular follow-up to monitor your health and any potential side effects. The total duration of your involvement in the study would be explained to you in detail by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as contributing valuable information that could improve stroke prevention for future patients with atrial fibrillation. You would also receive close medical attention and monitoring from the study team. However, there are potential risks, primarily related to the medications being studied, such as bleeding. There's also the chance the medication might not prevent strokes as effectively for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany
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Unverified
Belgium

Common questions

What is atrial fibrillation?

Atrial fibrillation (AFib) is a common heart condition where your heart beats with an irregular or very fast rhythm. It isn't usually life-threatening but can increase your risk of stroke.

What is a catheter ablation?

Catheter ablation is a procedure where doctors use thin, flexible wires (catheters) guided into your heart to correct the areas causing the irregular heart rhythm in AFib.

Why is this study important?

This study is important because it aims to find the best way to prevent strokes in people who've had a catheter ablation for AFib, by comparing different blood-thinning medicines.

What are 'covert' strokes?

'Covert' strokes are very small strokes in the brain that might not cause any obvious symptoms but can be detected on special brain scans like an MRI. They may still have long-term effects.

Will I know which medication I'm taking?

In some clinical trials, you might not know which specific medication you are receiving (this is called 'blinding') to ensure fair results. The study team will explain this to you.