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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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