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

Meda Pharmaceuticals

Status and phase

Terminated

Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Flecainide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00408473

1556-FLEC

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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