Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT00408473
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 256
- History of first symptomatic & documented episode of AF
- LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
- Secondary Outcome Measures
Name Time Method Number of emergency admissions due to AF recurrence Cardiac Safety Total number of AF recurrences during the treatment period Total number of patients in sinus rhythm at the end of the study AF Burden
Trial Locations
- Locations (47)
Patrick KOHAN, 18 rue de la Commanderie
🇫🇷Nancy, France
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
🇧🇬Burgas, Bulgaria
Hôpital St.-Joseph, Rue de la Duchère 6
🇧🇪Gilly, Belgium
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
🇧🇬Pleven, Bulgaria
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
🇧🇬Ruse, Bulgaria
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
🇷🇴Brasov, Romania
National Cardiology Hospital EAD, 65 Konjovitza Str.
🇧🇬Sofia, Bulgaria
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
🇧🇬Sofia, Bulgaria
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
🇧🇬Sofia, Bulgaria
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
🇧🇬Varna, Bulgaria
Virga Jesse Ziekenhuis, Stadsomvaart 11
🇧🇪Hassel, Belgium
Imeldaziekenhuis, Imeldalaan 9
🇧🇪Bonheiden, Belgium
Clinique Sainte-Elisabet, Place Louise Godin 1
🇧🇪Namur, Belgium
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
🇧🇪Leuven, Belgium
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
🇧🇬Sofia, Bulgaria
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
🇧🇬Sofia, Bulgaria
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
🇧🇬Sofia, Bulgaria
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
🇫🇷Arras, France
Centre Hospitalier Général, 22, boulevard Général Sibille
🇫🇷Albi, France
Hopital d'instruction des armées, rue Colonel Fonferrier
🇫🇷Brest, France
Philippe CHEMIN, 49 rue du Bocage
🇫🇷Bordeaux, France
Centre Hospitalier Général, 516 avenue de Paris
🇫🇷Cambrai, France
Patrick GIRAUD, Bat C 132 av Gabriel Péri
🇫🇷Cavaillon, France
André CORBIN, 28 rue du Conte de la Garaye
🇫🇷Dinan, France
Centre Hospitalier du Leman, 3 avenue de la dame
🇫🇷Evian-thonon, France
Verschuersen Iordanka, 4 rue Béranger
🇫🇷Fontainebleau, France
Jean Claude GICHTENAERE, 8 quai du Général Leclerc
🇫🇷Martigues, France
Centre Hospitalier Général, 10 rue de la Charité
🇫🇷Langres, France
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
🇫🇷Freyming Merlebach, France
Résidence Médicale Les Roses, 57, route de Lavérune
🇫🇷Montpellier, France
CHI Montfermeil, 10 rue du Gal Leclerc
🇫🇷Montfermeil, France
Centre Hospitalier Regional, 1 rue du Friscaty
🇫🇷Thionville, France
Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
🇫🇷Toulon, France
Centre médical, Promenade du petit Languedoc
🇫🇷Villefranche de Rouergue, France
Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
🇩🇪Bad Berka, Germany
Klinikum Coburg , Ketschendorfer Str. 33
🇩🇪Coburg, Germany
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
🇩🇪Münster, Germany
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
🇩🇪Bonn, Germany
Div Cardiology; University Hospital , Leipzigen St 44 -
🇩🇪Magdeburg, Germany
Kardiologische Praxis, Magirusstr.49
🇩🇪Ulm, Germany
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25
🇳🇱Maastricht, Netherlands
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
🇷🇴Bucuresti, Romania
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
🇷🇴Bucuresti, Romania
Centrul de Cardiologie , Str. Tabaci No. 1
🇷🇴Craiova, Romania
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
🇷🇴Cluj - Napoca, Romania
CARDIO EXPERT, Str. Romulus, Nr. 62.
🇷🇴Timisoara, Romania
Hospital Universitario de Getafe, Carretera de toledo
🇪🇸Madrid, Spain