Back to results

Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia (FLECA-ED)

Primary Purpose

Atrial Fibrillation Paroxysmal, Coronary Artery Disease Without Residual Ischemia

Status

Recruiting

Phase

Phase 3

Locations

Greece

Study Type

Interventional

Intervention

Flecainide Injectable Solution

Amiodarone Injectable Solution

About this trial

This is an interventional treatment trial for Atrial Fibrillation Paroxysmal focused on measuring Flecainide, Amiodarone

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-85 years old
Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:
1. Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department
2. 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
3. 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.

Exclusion Criteria:

Based on ECG at the Emergency Department:
1. Atrial Flutter
2. Newly documented Left Bundle Branch Block (LBBB)
3. 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:
1. If troponin at t0h is over the "low" criterion on table of the cutoff values
2. 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:
1. Positive imaging-based stress testing
2. 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.

Sites / Locations

Athens Heart Center Amarousion
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens, Athens, GreeceRecruiting
Attikon General Hospital of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Flecainide

Amiodarone

Arm Description

Outcomes

Primary Outcome Measures

The frequency of successful cardioversion to sinus rhythm

The combined frequency of premature ventricular contractions (PVCs), non-sustained ventricular tachycardia (NSVT), sustained ventricular tachycardia (SVT), bradycardia < 50bpm and systolic blood pressure < 90mmHg.

Secondary Outcome Measures

The frequency of patient discharges from the Emergency Department in sinus rhythm

The frequency of successful cardioversion to sinus rhythm

The time until the cardioversion to sinus rhythm

The frequency of electrical cardioversion

The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes

The frequency, severity and type of Adverse Events

Full Information

NCT ID

NCT05549752

First Posted

September 18, 2022

Last Updated

March 27, 2023

Sponsor

Hippocration General Hospital

Collaborators

Win Medica, Pharmassist Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05549752

Brief Title

Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia

Acronym

FLECA-ED

Official Title

Safety and Efficacy of Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction > 35%

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 24, 2023 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hippocration General Hospital

Collaborators

Win Medica, Pharmassist Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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. These recommendations stem from insufficient data, mainly from the CAST study. The present study is a prospective, multicentre, randomized clinical trial. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation at the Emergency Department, and to prove that the safety of flecainide is non-inferior to amiodarone, in patients with coronary artery disease without residual ischemia and ejection fraction over 35%. The secondary goals of the study are to prove the superiority of flecainide over amiodarone in the reduction of hospitalizations from the Emergency Department due to atrial fibrillation, in the time taken to achieve cardioversion, and to the reduction of the need to conduct electrical cardioversion. The study population will be all consecutive new-comers to the Emergency Department with primary diagnosis of paroxysmal atrial fibrillation and history of coronary artery disease without angina, without residual ischemia and with ejection fraction > 35%. The sample size will be 200 patients, who will be monitored for 30 days. At the Emergency Department, all patients will be under continuous ECG monitoring, and a 24-hour ECG device will also be placed (Holter). The patients will be randomized to the treatment group (flecainide) and the control group (amiodarone). Patients in both arms will stay at the ED for a total of 6 hours after therapy initiation. If no adverse events occur in this time, the patient will be discharged from the ED. Otherwise, the patient will be admitted to the hospital. At 24 hours, the patients will visit the study centre for physical examination, ECG, cardiac ultrasound, 24-hour ECG removal and adverse events evaluation. At 30 days, follow-up via phone calls will be conducted for the evaluation of the study outcomes and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation Paroxysmal, Coronary Artery Disease Without Residual Ischemia

Keywords

Flecainide, Amiodarone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Flecainide

Arm Type

Active Comparator

Arm Title

Amiodarone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Flecainide Injectable Solution

Intervention Description

Intravenous Flecainide at a dose of 2.0mg/kg (maximum dose: 150mg) in 100ml D/W 5% for 10 minutes.

Intervention Type

Drug

Intervention Name(s)

Amiodarone Injectable Solution

Intervention Description

Intravenous Amiodarone at a dose of 5.0-7.0 mg/kg for 1 hour, and maintenance dose of 50mg/h (maximum dose: 1000mg) for up to 24 hours.

Primary Outcome Measure Information:

Title

The frequency of successful cardioversion to sinus rhythm

Time Frame

From the drug initiation and for 6 hours

Title

Time Frame

From the drug initiation and for 6 hours

Secondary Outcome Measure Information:

Title

The frequency of patient discharges from the Emergency Department in sinus rhythm

Time Frame

From the drug initiation and for 6 hours

Title

The frequency of successful cardioversion to sinus rhythm

Time Frame

From the drug initiation and for 24 hours, 24 hour ECG Holter monitoring

Title

The time until the cardioversion to sinus rhythm

Time Frame

From the drug initiation and for 6 hours

Title

The frequency of electrical cardioversion

Time Frame

From the drug initiation and for 24 hours

Title

The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes

Time Frame

From the drug initiation and for 24 hours

Title

The frequency, severity and type of Adverse Events

Time Frame

From the drug initiation and for 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Konstantinos P Tsioufis, Professor

Phone

2132088000

ktsioufis@hippocratio.gr

Facility Information:

Facility Name

Athens Heart Center Amarousion

City

Athens

State/Province

Attiki

ZIP/Postal Code

15125

Country

Greece

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dimitrios Tsiachris, MD

dtsiachris@yahoo.com

First Name & Middle Initial & Last Name & Degree

Dimitrios Tsiachris, MD

Facility Name

First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens, Athens, Greece

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Konstantinos P Tsioufis, Professor

Phone

2132088000

Ext

8099

ktsioufis@hippocratio.gr

First Name & Middle Initial & Last Name & Degree

Konstantinos P Tsioufis, Professor

First Name & Middle Initial & Last Name & Degree

Panagiotis K Tsioufis, MD

First Name & Middle Initial & Last Name & Degree

Ioannis G Doundoulakis, MD

Facility Name

Attikon General Hospital of Athens

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ioannis Parisis, Professor

First Name & Middle Initial & Last Name & Degree

Ioannis Parisis, Professor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia

We'll reach out to this number within 24 hrs