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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00408473
Recruitment Status : Terminated
First Posted : December 7, 2006
Last Update Posted : February 7, 2022
Sponsor:
Collaborator:
3M
Information provided by:
Viatris Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Flecainide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 the National Library of Medicine

Drug Information available for: Flecainide

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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408473


Locations
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Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
3M
Investigators
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Principal Investigator: Prof E Aliot CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
More Information
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ClinicalTrials.gov Identifier: NCT00408473    
Other Study ID Numbers: 1556-FLEC
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2007
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
 Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action