Clinical trial NCT00408473: Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2006-12-07
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
Secondary outcomes:
measure: Total number of AF recurrences during the treatment period
measure: Total number of patients in sinus rhythm at the end of the study
measure: AF Burden
measure: Number of emergency admissions due to AF recurrence
measure: Cardiac Safety
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis, Imeldalaan 9
city: Gilly
country: Belgium
facility: Hôpital St.-Joseph, Rue de la Duchère 6
city: Hassel
country: Belgium
facility: Virga Jesse Ziekenhuis, Stadsomvaart 11
city: Leuven
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
city: Namur
country: Belgium
facility: Clinique Sainte-Elisabet, Place Louise Godin 1
city: Burgas
country: Bulgaria
facility: Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
city: Pleven
country: Bulgaria
facility: Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
city: Ruse
country: Bulgaria
facility: Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
city: Sofia
country: Bulgaria
facility: Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
city: Sofia
country: Bulgaria
facility: National Cardiology Hospital EAD, 65 Konjovitza Str.
city: Sofia
country: Bulgaria
facility: Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
city: Sofia
country: Bulgaria
facility: Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
city: Sofia
country: Bulgaria
facility: Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
city: Sofia
country: Bulgaria
facility: Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
city: Varna
country: Bulgaria
facility: CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
city: Albi
country: France
facility: Centre Hospitalier Général, 22, boulevard Général Sibille
city: Arras
country: France
facility: Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
city: Bordeaux
country: France
facility: Philippe CHEMIN, 49 rue du Bocage
city: Brest
country: France
facility: Hopital d'instruction des armées, rue Colonel Fonferrier
city: Cambrai
country: France
facility: Centre Hospitalier Général, 516 avenue de Paris
city: Cavaillon
country: France
facility: Patrick GIRAUD, Bat C 132 av Gabriel Péri
city: Dinan
country: France
facility: André CORBIN, 28 rue du Conte de la Garaye
city: Evian-thonon
country: France
facility: Centre Hospitalier du Leman, 3 avenue de la dame
city: Fontainebleau
country: France
facility: Verschuersen Iordanka, 4 rue Béranger
city: Freyming Merlebach
country: France
facility: Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
city: Langres
country: France
facility: Centre Hospitalier Général, 10 rue de la Charité
city: Martigues
country: France
facility: Jean Claude GICHTENAERE, 8 quai du Général Leclerc
city: Montfermeil
country: France
facility: CHI Montfermeil, 10 rue du Gal Leclerc
city: Montpellier
country: France
facility: Résidence Médicale Les Roses, 57, route de Lavérune
city: Nancy
country: France
facility: Patrick KOHAN, 18 rue de la Commanderie
city: Thionville
country: France
facility: Centre Hospitalier Regional, 1 rue du Friscaty
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
city: Villefranche de Rouergue
country: France
facility: Centre médical, Promenade du petit Languedoc
city: Bad Berka
country: Germany
facility: Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
city: Bonn
country: Germany
facility: Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
city: Coburg
country: Germany
facility: Klinikum Coburg , Ketschendorfer Str. 33
city: Magdeburg
country: Germany
facility: Div Cardiology; University Hospital , Leipzigen St 44 -
city: Münster
country: Germany
facility: Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
city: Ulm
country: Germany
facility: Kardiologische Praxis, Magirusstr.49
city: Maastricht
country: Netherlands
facility: "Academisch Ziekenhuis Maastricht, P. Debyelaan 25
city: Brasov
country: Romania
facility: SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
city: Bucuresti
country: Romania
facility: "SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
city: Cluj - Napoca
country: Romania
facility: "SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
city: Craiova
country: Romania
facility: Centrul de Cardiologie , Str. Tabaci No. 1
city: Timisoara
country: Romania
facility: CARDIO EXPERT, Str. Romulus, Nr. 62.
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe, Carretera de toledo
Study officials:
affiliation: CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
name: Prof E Aliot
role: PRINCIPAL_INVESTIGATOR
References: