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Study on Flecainide and Amiodarone for Treating Atrial Fibrillation in Patients with Coronary Artery Disease and Ejection Fraction Over 35%

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of paroxysmal atrial fibrillation, a condition where the heart experiences irregular and often rapid beating. The study involves patients who have coronary artery disease but do not have ongoing heart muscle damage, and their heart's pumping ability is above 35%. The trial compares two medications: flecainide acetate and amiodarone hydrochloride. Both are used to help restore a normal heart rhythm. Flecainide is being tested to see if it is more effective and just as safe as amiodarone in converting the heart to a normal rhythm in the emergency department setting.

The purpose of the study is to determine if flecainide is better than amiodarone in helping patients return to a normal heart rhythm. Participants will receive either flecainide or amiodarone through an injection. The study will monitor how well each medication works in restoring normal heart rhythm and how safe they are for the patients. The effects of the medications will be observed for up to 24 hours, with particular attention to any side effects or complications that may arise.

Throughout the study, the frequency of successful heart rhythm conversion and any side effects will be recorded. The trial aims to provide valuable information on the effectiveness and safety of these medications in treating paroxysmal atrial fibrillation in patients with coronary artery disease. This research could help improve treatment options for individuals experiencing this heart condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon arrival at the Emergency Department, an initial assessment is conducted to confirm eligibility for the trial. This includes verifying age, medical history, and current condition.
A 12-lead ECG is performed to document the presence of paroxysmal atrial fibrillation (AF).
Step 2
Consent and enrollment
After confirming eligibility, the patient is asked to sign an informed consent form to participate in the trial.
Once consent is obtained, the patient is officially enrolled in the study.
Step 3
Randomization and treatment allocation
The patient is randomly assigned to receive either flecainide acetate or amiodarone hydrochloride.
Both medications are administered as a solution for injection.
Step 4
Medication administration
The assigned medication is administered via injection in the Emergency Department.
The goal is to convert the heart rhythm from AF to a normal sinus rhythm.
Step 5
Monitoring and evaluation
The patient is monitored for up to 6 hours to assess the success of the cardioversion to sinus rhythm.
Monitoring includes checking for any side effects such as irregular heartbeats or changes in blood pressure.
Step 6
Follow-up and discharge
If the heart rhythm is successfully converted to sinus rhythm, the patient may be discharged from the Emergency Department.
Further monitoring may be conducted for up to 24 hours, including a 24-hour Holter monitor to track heart activity.
Step 7
Extended observation
The patient is observed for any adverse effects for up to 30 days following the administration of the medication.
This includes tracking any episodes of arrhythmias or other related symptoms.

Who can join the trial?

9 criteria

Age between 18 and 25 years old.
Have a condition called paroxysmal atrial fibrillation (AF), which is a type of irregular heartbeat. This must be confirmed by a test called a 12-lead ECG. The AF must have started less than 48 hours before arriving at the Emergency Department, or between 48 hours and 7 days with at least 30 days of blood-thinning medication.
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Have a history of coronary artery disease without ongoing heart muscle damage. This can be shown by one of the following:
- Had a procedure called angioplasty within the past year.
- Had coronary artery bypass surgery within the last 3 years.
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  Had a negative result on a heart stress test using imaging within the past year, and also:
  - Had angioplasty more than a year ago, or
  - Had coronary artery bypass surgery more than 3 years ago, or
  - Has a history of a narrowing in the heart arteries greater than 60% without treatment to open them.
  - Have a left ventricular ejection fraction greater than 35%, which is a measure of how well the heart pumps blood. This must be confirmed by a heart ultrasound in the Emergency Department or within the last year.
  - Must sign a form agreeing to participate in the study, known as an informed consent form.

Who cannot join the trial?

5 criteria

Patients with a left ventricular ejection fraction of 35% or less cannot participate. This is a measure of how well the heart is pumping blood.
Patients with residual ischemia are excluded. This means there is still a lack of blood flow to the heart.
Patients who are not experiencing paroxysmal atrial fibrillation are not eligible. This is a type of irregular heartbeat that starts and stops suddenly.
Patients who are not in the Emergency Department for treatment are not eligible.
Patients who do not have coronary artery disease are excluded. This is a condition where the heart's blood vessels are narrowed or blocked.

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Verified sites

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General Hospital Of Nea Ionia Konstantopouleio Patision
Nea Ionia, Greece
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Hippokration Hospital
Athens, Greece

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Investigated drugs

Flecainide
is a medication used to help restore a normal heart rhythm in people experiencing certain types of irregular heartbeats, such as paroxysmal atrial fibrillation. In this trial, flecainide is being tested to see if it is more effective than another medication in converting an irregular heartbeat back to a normal rhythm in patients who have heart disease but no ongoing heart muscle damage and a heart pumping ability above 35%.
Amiodarone
is another medication used to treat and prevent a variety of irregular heartbeats. It works by helping to stabilize the heart's rhythm. In this trial, amiodarone is being used as a comparison to see if flecainide is better at converting an irregular heartbeat to a normal rhythm in the same group of patients. The trial also aims to ensure that flecainide is at least as safe as amiodarone for these patients.

What is already known about the treatment

Flecainide
Flecainide is administered orally or intravenously and is used to treat certain types of irregular heartbeats, specifically for the cardioversion of paroxysmal atrial fibrillation. It is currently being studied in clinical trials to assess its safety and effectiveness compared to amiodarone. The main therapeutic indication is the conversion of paroxysmal atrial fibrillation to a normal heart rhythm in patients with coronary artery disease. Flecainide works by blocking specific sodium channels in the heart, which helps to stabilize the heart's electrical activity. It is classified as a Class IC antiarrhythmic agent.
Amiodarone
Amiodarone is typically administered orally or intravenously and is used to treat and prevent various types of irregular heartbeats, including atrial fibrillation. It is being compared to flecainide in clinical trials to determine its effectiveness and safety in converting paroxysmal atrial fibrillation to a normal rhythm. The main therapeutic indication is the management of arrhythmias in patients with coronary artery disease. Amiodarone works by affecting the potassium channels in the heart, prolonging the phase of repolarization and stabilizing the heart's rhythm. It is classified as a Class III antiarrhythmic agent.

Investigated diseases

Paroxysmal Atrial Fibrillation – This is a type of irregular heartbeat that starts and stops suddenly. It occurs when the heart's upper chambers beat out of sync with the lower chambers. Episodes can last from a few minutes to several hours and may happen occasionally. During an episode, the heart may feel like it's racing or fluttering. It can lead to symptoms such as palpitations, shortness of breath, and fatigue. The condition can be triggered by stress, alcohol, or caffeine, but often the cause is unknown.