Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A perspective multicenter randomized clinical trial for the safety and efficacy of flecainide compared to amiodorone for the conversion of paroxysmal atrial fibrillation in the Emergency Department in patients with coronary disease without residual ischemia and ejection fraction >35% (FLECA-ED)

This research study, called FLECA-ED, is comparing two medications, flecainide (FLECARDIA) and amiodarone (Angoron), to see which works best and is safest for people who come to the emergency room with a fast, irregular heart rhythm called paroxysmal atrial fibrillation. This is a common type of irregular heartbeat that starts and stops suddenly. The study is specifically for adults who also have coronary artery disease (narrowing of the heart's arteries) but whose hearts are still pumping strongly and don't have new heart damage. Doctors want to find out how quickly and often these medicines can get the heart back to a normal rhythm and if there are any side effects. The goal is to improve how doctors treat this condition in an emergency setting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Win Medica Pharmaceutical S.A.

Enrolment target

200

Start

15 Jan 2025

Cardioversion of paroxysmal atrial fibrillation in the Emergency Department in patients with coronary artery disease without residual ischemia and an left ventricular ejection fraction > 35%

What is this study about?

Imagine your heart is a drummer, but sometimes it starts beating erratically, like a drum solo gone wild. This is called atrial fibrillation, and when it comes on suddenly and doesn't last too long, it's called paroxysmal atrial fibrillation. Sometimes, when this happens, doctors in the emergency department need to give medication to help your heart get back to a normal, steady rhythm. This process is called cardioversion.

This study, FLECA-ED, is comparing two common medications, flecainide and amiodarone, that are used to help reset the heart's rhythm. Doctors want to find out which of these two medicines is more effective at quickly and safely bringing the heart back to a normal rhythm in people who arrive at the emergency room with this condition. They are also looking closely at any side effects the medicines might cause.

This research is particularly focused on people who also have coronary artery disease, which means the arteries supplying blood to their heart are narrowed. However, it's only for those whose hearts are still pumping well and haven't had recent damage. By comparing these two treatments, researchers hope to give doctors clearer guidance on the best way to help patients in this situation, leading to better care for people experiencing sudden irregular heartbeats.

Key takeaways

This study compares two common medications (flecainide, amiodarone) for irregular heartbeats.
It's for people in the emergency room with sudden irregular heartbeats (atrial fibrillation).
Suitable for those with heart artery disease, as long as their heart pumps well.
Aims to find out which medicine is safer and more effective at restoring normal heart rhythm.
Participation involves receiving one of the medicines and close monitoring over 24 hours, with follow-up.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over, of any gender. To be considered, you would need to be in the emergency department because you are experiencing paroxysmal atrial fibrillation, which is an irregular heartbeat that comes and goes suddenly.

You also need to have been diagnosed with coronary artery disease, which means you have some narrowing in the blood vessels that supply your heart. However, it's important that your heart is still pumping blood effectively and that you haven't recently had a heart attack or other new heart damage.

There might be other health conditions or medications that would mean you couldn't join the study, as safety is always the top priority. The study team would discuss all the specific requirements with you to see if it's a good fit.

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?
Are you currently in the Emergency Department with a sudden, irregular heartbeat (paroxysmal atrial fibrillation)?
Have you been diagnosed with coronary artery disease?
Does your heart still pump blood effectively (heart 'ejection fraction' described as >35%) and have you not had recent heart damage?
Are you able to stay for monitoring for up to 24 hours?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you would receive either flecainide or amiodarone in the emergency department through an injection or drip to help your heart rhythm return to normal. During the first six hours after getting the medicine, doctors and nurses would carefully monitor your heart rhythm and blood pressure, looking to see if your heart returns to its normal beat and if you have any side effects.

They would continue to monitor you for up to 24 hours, possibly using a small portable heart monitor (a Holter monitor) to keep track of your heart's activity. Researchers will also keep an eye on how you're feeling and any health changes for up to 30 days after receiving the medication. This might involve a follow-up call or visit. The total duration of your active involvement with doctors monitoring you closely in the emergency department is up to 24 hours, with a follow-up for side effects for a month.

Potential risks and benefits

Taking part in any medical study carries both potential benefits and risks. You might benefit from close medical monitoring and receive a treatment that could quickly restore your heart's normal rhythm. However, there's a chance the medication might not work, or you could experience side effects, such as changes in your heart rhythm or blood pressure. The study medicines themselves have known risks, and the research team will explain these thoroughly. You always have the right to withdraw from the study at any time, for any reason, without it 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
Greece

Common questions

What is paroxysmal atrial fibrillation?

It's a type of irregular and often fast heartbeat that starts and stops suddenly on its own.

What does 'cardioversion' mean?

It's a medical procedure, in this case using medication, to get your heart back to a normal, steady rhythm.

What is coronary artery disease?

It's a condition where the blood vessels supplying your heart become narrowed, potentially reducing blood flow.

Will I know which medicine I'm getting?

Because this is a 'randomised' study, you will be assigned to one of the two medicines by chance, like flipping a coin. You might not know which one you're receiving.

How long will I be monitored?

You'll be closely monitored for up to 24 hours in the Emergency Department, with a check for any side effects for up to 30 days.