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

This study has been terminated.
Information provided by:
MEDA Pharma GmbH & Co. KG Identifier:
First received: December 6, 2006
Last updated: February 21, 2007
Last verified: February 2007
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.

Condition Intervention Phase
Atrial Fibrillation
Drug: Flecainide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised Double-Blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.

Resource links provided by NLM:

Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.

Secondary Outcome Measures:
  • Total number of AF recurrences during the treatment period
  • Total number of patients in sinus rhythm at the end of the study
  • AF Burden
  • Number of emergency admissions due to AF recurrence
  • Cardiac Safety

Estimated Enrollment: 256

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00408473

  Show 47 Study Locations
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Principal Investigator: Prof E Aliot CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
  More Information Identifier: NCT00408473     History of Changes
Other Study ID Numbers: 1556-FLEC 
Study First Received: December 6, 2006
Last Updated: February 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers processed this record on May 26, 2016