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

Hide Study Locations

Locations

Belgium
Imeldaziekenhuis, Imeldalaan 9
Bonheiden, Belgium, 2820
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
Leuven, Belgium, B - 3000
Clinique Sainte-Elisabet, Place Louise Godin 1
NAMUR, Belgium, B - 5000
Hôpital St.-Joseph, Rue de la Duchère 6
Gilly, Belgium, B-6060
Virga Jesse Ziekenhuis, Stadsomvaart 11
HASSEL, Belgium, B - 3500
Bulgaria
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
SOFIA, Bulgaria, 1606
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
SOFIA, Bulgaria, 1202
National Cardiology Hospital EAD, 65 Konjovitza Str.
SOFIA, Bulgaria, 1309
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
SOFIA, Bulgaria, 1504
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
BURGAS, Bulgaria, 8000
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
SOFIA, Bulgaria, 1431
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
VARNA, Bulgaria, 9010
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
SOFIA, Bulgaria, 1606
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
PLEVEN, Bulgaria, 5800
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
RUSE, Bulgaria, 7002
France
CHI Montfermeil, 10 rue du Gal Leclerc
MONTFERMEIL, France, 93370
Centre Hospitalier Général, 516 avenue de Paris
CAMBRAI, France, 59,407
Jean Claude GICHTENAERE, 8 quai du Général Leclerc
MARTIGUES, France, 13,500
Philippe CHEMIN, 49 rue du Bocage
BORDEAUX, France, 33,200
André CORBIN, 28 rue du Conte de la Garaye
DINAN, France, 22,100
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
Freyming Merlebach, France, 57 804
Centre Hospitalier Général, 22, boulevard Général Sibille
ALBI, France, 81,000
Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
TOULON, France, 83,100
Patrick GIRAUD, Bat C 132 av Gabriel Péri
CAVAILLON, France, 84300
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
ARRAS, France, 62000
Centre Hospitalier du Leman, 3 avenue de la dame
EVIAN-THONON, France, 74203
Patrick KOHAN, 18 rue de la Commanderie
NANCY, France, 54000
Centre Hospitalier Général, 10 rue de la Charité
LANGRES, France, 52200
Résidence Médicale Les Roses, 57, route de Lavérune
MONTPELLIER, France, 34070
Hopital d'instruction des armées, rue Colonel Fonferrier
BREST, France, 29200
Centre Hospitalier Regional, 1 rue du Friscaty
THIONVILLE, France, 57126
Verschuersen Iordanka, 4 rue Béranger
FONTAINEBLEAU, France, 77300
Centre médical, Promenade du petit Languedoc
VILLEFRANCHE DE ROUERGUE, France, 12200
Germany
Klinikum Coburg , Ketschendorfer Str. 33
Coburg, Germany, D-96450
Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
Bad Berka, Germany, 99437
Div Cardiology; University Hospital , Leipzigen St 44 -
MAGDEBURG, Germany, 39120
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
Münster, Germany, D-48129
Kardiologische Praxis, Magirusstr.49
Ulm, Germany, D 89077
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
BONN, Germany, D53105
Netherlands
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25
Maastricht, Netherlands, 6229 HX
Romania
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
BUCURESTI, Romania, 020125
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
BUCURESTI, Romania, 011461
Centrul de Cardiologie , Str. Tabaci No. 1
CRAIOVA, Romania, 200642
CARDIO EXPERT, Str. Romulus, Nr. 62.
TIMISOARA, Romania, 300203
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
BRASOV, Romania, 500157
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
CLUJ - NAPOCA, Romania, 400347
Spain
Hospital Universitario de Getafe, Carretera de toledo
Madrid, Spain, 28905

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 25, 2009