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Compares treatment options for Atrial Fibrillation Paroxysmal
Official title Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia
ClinicalTrials.gov ID: NCT05549752
What this study is testing
What is Flecainide Injectable Solution?
Flecainide Injectable Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation paroxysmal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Current guidelines for the cardioversion of paroxysmal Atrial Fibrillation at the Emergency Department do not prioritize between antiarrhythmic agents and do not consider the time taken for successful cardioversion. Furthermore, the use of flecainide -a class 1C antiarrhythmic agent- is contraindicated for the cardioversion of patients with revascularized coronary artery disease, as well as patients with ischemic cardiomyopathy and preserved ejection fraction.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age: 18-85 years old
- Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
- Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department
- Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, and patient has been on...
- History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:
You likely can't join if
- Based on ECG at the Emergency Department:
- Atrial Flutter
- Newly documented Left Bundle Branch Block (LBBB)
- Newly documented Right Bundle Branch Block (RBBB) with QRS duration \> 150ms
- Previously documented 24-hour ECG holter monitoring with \> 720 poly PVCs/24hours, or non sustained ventricular tachycardia
- No history of coronary artery disease
See the full eligibility criteria
- Age: 18-85 years old
- Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
- Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department
- Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, and patient has been on anticoagulation for at least 30 days
- History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:
- PCI \<= 1 year, or
- CABG \<= 3 years, or
- Negative imaging-based stress testing within 1 year, and:
- History of known coronary artery stenosis \> 60% without revascularization, or
- PCI \>= 1 year, or
- CABG \>= 3 years
- Ejection Fraction \> 35% (documented by cardiac ultrasound at the Emergency Department, or within 1 year)
- Signed informed consent from the patient or legal representative.
- Based on ECG at the Emergency Department:
- Atrial Flutter
- Newly documented Left Bundle Branch Block (LBBB)
- Newly documented Right Bundle Branch Block (RBBB) with QRS duration \> 150ms
- Previously documented 24-hour ECG holter monitoring with \> 720 poly PVCs/24hours, or non sustained ventricular tachycardia
- No history of coronary artery disease
- ST-Segment Elevation Myocardial Infarction (STEMI)
- Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:
- If troponin at t0h is over the "low" criterion on table of the cutoff values
- If the change of troponin (Δtroponin) at t1h is over the respective cutoff value at the table for the cutoff values
- Unstable angina, defined as myocardial ischemia at rest or at minimum effort, in the absence of acute injury/necrosis of myocardial cells
- Known residual ischemia:
- Positive imaging-based stress testing
- Negative imaging-based stress testing \>= 1 year, and:
- History of known coronary artery stenosis \> 60% without revascularization, or
- PCI \>= 1 year, or
- CABG \>= 3 years
- History of acute coronary syndrome within 1 year
- Severe Aortic Valve Stenosis (mean pressure gradient \> 40mmHg, AVA \< 1cm/m\^2)
- Severe Chronic Kidney Disease (stage \>= 4)
- Severe systematic disease, including neoplasmatic disease under any antineoplasmatic treatment, liver failure, infection with fever
- Use of strategy "pill in the pocket", by taking flecainide (max 200mg) or propafenone (max 600mg) within 6 hours prior to Emergency Department visit
- Known dysanexia or allergy to flecainide or amiodarone
- Pregnancy or/and breastfeeding
- Participation in any other clinical trial
- Life expectancy less than 1 year
- Inappropriate, unfit, or unwilling to follow the desingated protocol procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.