Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with age.1 According to the most recent guidelines, class Ic anti-arrhythmic drugs are considered the first line treatment in patients without significant structural heart disease. Flecainide is effective in preventing AF recurrences in 31-61% of cases according to different studies.2-5 A recent study showed that the combination of Flecainide and Metoprolol improves effective rhythm control in patients with persistent symptomatic AF compared to Flecainide or Metoprolol alone.6 In contrast, the combination of Flecainide and Metoprolol conferred no significant benefit over Flecainide alone in patients with paroxysmal AF. This suggests different underlying mechanisms for paroxysmal and persistent AF. Pulmonary veins are likely the main focus triggering paroxysmal AF while in persistent AF the role of pulmonary veins is less important.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Flecainide; Metoprolol; Polystyrene sulfonic acid; Ranolazine

Criteria

Inclusion Criteria:

• patients with AF

• recently converted to sinus rhythm (>24hrs and < 7 days)

• admitted in the 3rd University Cardiology Clinic of Ippokrateion Hospital

• eligible to participate in the study and follow the study procedures

• signed informed consent

Exclusion Criteria:

• use of IC antiarrhythmic agents or

• Sotalol during the last 48 hours,

• chronic use of oral or intravenous Amiodarone for the last 48 hours,

• recent acute coronary syndrome,

• heart failure New York Heart Association class III or IV,

• severe left ventricular dysfunction with left ventricular ejection fraction <40%,

• atrioventricular conduction disorders (atrioventricular block,

• complete left bundle branch block and bi-fascicular block),

• heart rate < 50 bpm,

• sick sinus syndrome,

• thyroid dysfunction and severe pulmonary, renal, or

• liver disease

• - not eligible to participate in the study and follow the study procedures

• no signed informed consent