Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
NCT ID: NCT00408473
Last Updated: 2022-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
256 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Flecainide
Eligibility Criteria
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Inclusion Criteria
* LVEF \> 40% and not on AAD and in sinus rhythm at time of recruitment
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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3M
INDUSTRY
MEDA Pharma GmbH & Co. KG
INDUSTRY
Principal Investigators
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Prof E Aliot
Role: PRINCIPAL_INVESTIGATOR
CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
Locations
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Imeldaziekenhuis, Imeldalaan 9
Bonheiden, , Belgium
Hôpital St.-Joseph, Rue de la Duchère 6
Gilly, , Belgium
Virga Jesse Ziekenhuis, Stadsomvaart 11
Hassel, , Belgium
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
Leuven, , Belgium
Clinique Sainte-Elisabet, Place Louise Godin 1
Namur, , Belgium
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
Burgas, , Bulgaria
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
Pleven, , Bulgaria
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
Rousse, , Bulgaria
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
Sofia, , Bulgaria
National Cardiology Hospital EAD, 65 Konjovitza Str.
Sofia, , Bulgaria
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
Sofia, , Bulgaria
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
Sofia, , Bulgaria
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
Sofia, , Bulgaria
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
Sofia, , Bulgaria
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
Varna, , Bulgaria
Centre Hospitalier Général, 22, boulevard Général Sibille
Albi, , France
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
Arras, , France
Philippe CHEMIN, 49 rue du Bocage
Bordeaux, , France
Hopital d'instruction des armées, rue Colonel Fonferrier
Brest, , 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
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
Freyming-Merlebach, , France
Centre Hospitalier Général, 10 rue de la Charité
Langres, , France
Jean Claude GICHTENAERE, 8 quai du Général Leclerc
Martigues, , France
CHI Montfermeil, 10 rue du Gal Leclerc
Montfermeil, , France
Résidence Médicale Les Roses, 57, route de Lavérune
Montpellier, , France
Patrick KOHAN, 18 rue de la Commanderie
Nancy, , 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
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
Bonn, , Germany
Klinikum Coburg , Ketschendorfer Str. 33
Coburg, , Germany
Div Cardiology; University Hospital , Leipzigen St 44 -
Magdeburg, , Germany
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
Münster, , Germany
Kardiologische Praxis, Magirusstr.49
Ulm, , Germany
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25
Maastricht, , Netherlands
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
Brasov, , Romania
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
Bucharest, , Romania
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
Bucharest, , Romania
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
Cluj-Napoca, , Romania
Centrul de Cardiologie , Str. Tabaci No. 1
Craiova, , Romania
CARDIO EXPERT, Str. Romulus, Nr. 62.
Timișoara, , Romania
Hospital Universitario de Getafe, Carretera de toledo
Madrid, , Spain
Countries
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Other Identifiers
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1556-FLEC
Identifier Type: -
Identifier Source: org_study_id
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