Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation. - Full Text View

Sponsor:	MEDA Pharma GmbH & Co. KG
Collaborator:	3M
Information provided by:	MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00408473

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Flecainide Flecainide acetate

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

Study ID Numbers:	1556-FLEC
Study First Received:	December 6, 2006
Last Updated:	February 21, 2007
ClinicalTrials.gov Identifier:	NCT00408473 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Therapeutic Uses
Flecainide
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009