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

This study has been terminated.
Sponsor:
Collaborator:
3M
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00408473
First received: December 6, 2006
Last updated: February 21, 2007
Last verified: February 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408473

  Show 47 Study Locations
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
3M
Investigators
Principal Investigator: Prof E Aliot CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
  More Information

No publications provided

ClinicalTrials.gov 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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Flecainide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013