Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

SHORT RUN AF. Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk

This important study, named SHORT RUN AF, is looking into how effective a medicine called rivaroxaban is. It’s for individuals who have frequent short bursts of irregular heartbeats, known as atrial ectopy or short atrial runs, and are also at a higher risk of having a stroke. The main goal is to find out if rivaroxaban can help prevent strokes or other blood clot-related problems. We also want to make sure it's safe and doesn't cause too much bleeding. This is a large-scale study, combining later phases of research to get clear answers quickly. If you have these specific heart rhythm issues and a high stroke risk, this study might be suitable for you.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

550

Start

04 Oct 2024

What is this study about?

This research, called SHORT RUN AF, is looking into a common heart rhythm issue where people have occasional extra or fast heartbeats, sometimes called 'skipped beats' or 'short runs' of irregular heart activity. While these might not always feel significant, in certain people, especially those already at a higher risk of stroke, these irregularities could potentially increase the chance of having a stroke.

The study aims to see if a medication called rivaroxaban can help prevent strokes in these specific individuals. Rivaroxaban is a type of medicine known as a blood thinner, which works by reducing the blood's ability to clot. We want to find out if taking rivaroxaban is better than the usual care for preventing strokes and other serious blood clot issues in this group of patients.

Researchers will be carefully tracking who has strokes and also closely monitoring for any side effects, particularly bleeding, which can be a risk with blood-thinning medicines. The information gathered from this study will help doctors understand the best way to treat people with these heart rhythm patterns to keep them safe from strokes.

Key takeaways

Tests rivaroxaban for stroke prevention in specific heart rhythm conditions.
Aims to reduce stroke risk for people with frequent irregular heartbeats.
Carefully monitors for both strokes and potential bleeding side effects.
Could help doctors decide the best care for patients with similar conditions.
Participation involves taking medication, regular check-ups, and scans.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would typically need to have frequent extra heartbeats or short periods of very fast heartbeats that are not a sustained irregular heart rhythm like atrial fibrillation. Doctors would usually find these by monitoring your heart's electrical activity over 24 hours or, in some cases, for up to 21 days.

You also need to have a higher risk of stroke, which doctors assess using a specific scoring system. This score helps them determine if you would likely benefit from blood-thinning medication.

Anyone, regardless of age or gender, who meets these specific heart rhythm and stroke risk criteria, might be able to take part in this important research.

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.

Have you had tests that show frequent extra heartbeats or short fast heart rhythm episodes?
Has your doctor told you that you are at a higher risk of stroke?
Are you willing to take a study medication (which may be rivaroxaban) and attend regular appointments?
Are you able to undergo occasional brain scans (MRI)?
Are you willing to have your heart activity monitored for periods of time?

Answer every question to see your result.

What does participation involve?

If you join the study, you will either receive rivaroxaban or continue with your doctor's usual care. You will have regular check-ups with the study team, likely involving physical exams and blood tests. Your heart activity might be monitored again, and you'll have brain scans (MRIs) to check for strokes. We will also ask about your general health and any symptoms you experience. The study will last for a certain period, and you'll have follow-up appointments to track your health and any side effects.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach for stroke prevention. You'd also be contributing valuable information that could help many others in the future. However, there are potential risks, mainly an increased risk of bleeding due to the blood-thinning medication. The research team will closely monitor you for any side effects. Remember, joining is entirely voluntary, and you have the right to leave the study at any time, for any reason, without 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
France

Common questions

What is 'excessive atrial ectopy'?

This means you have quite a few extra heartbeats or short bursts of fast heartbeats coming from the upper chambers of your heart, which doctors can see on a heart monitor.

What is rivaroxaban?

Rivaroxaban is a medicine that helps prevent blood clots from forming, often called a blood thinner. It's used in various conditions to reduce the risk of stroke or other clot-related problems.

Why is stroke risk important for this study?

The study focuses on people who have these irregular heartbeats AND are already at a higher risk of stroke. We want to see if rivaroxaban can specifically help prevent strokes in this high-risk group.

Will I know if I'm getting rivaroxaban?

In some studies, participants might not know immediately whether they are receiving the study drug or standard care, to ensure unbiased results. The research team will explain this to you fully.

What kind of bleeding are you looking for?

The team will be carefully checking for any major bleeding, which is a key safety measure for blood-thinning medicines. They will also track less serious bleeding events.