Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Collaborator: 3M
• Treatments: Flecainide

Criteria

Inclusion Criteria:

• History of first symptomatic & documented episode of AF

• LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment

Exclusion Criteria:

• History of more than 1 symptomatic documented AF episode, persistent or permanent AF.

• History of ablation for previous AF

• Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery

• Severe symptoms during AF episode (e.g.syncope, chest pain)

• All types of treated arrhythmias other than AF

• History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases

• Left ventricular ejection fraction (LVEF) ≤ 40%

• Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms

• Brugada syndrome

• Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block

• 2nd or 3rd degree atrioventricular (AV) block

• Sinus node dysfunction

• Severe hypertension with:Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic blood pressure ≥ 100 mmHg

• Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram

• Implanted pacemaker

• Heart surgery within the last 6 months, or non-stable postoperative condition

• Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (Cockroft and Gault formula

• Uncorrected electrolytic abnormalities

• Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion

• Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB