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Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.

Information source: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Flecainide (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: MEDA Pharma GmbH & Co. KG

Official(s) and/or principal investigator(s):
Prof E Aliot, Principal Investigator, Affiliation: CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Imeldaziekenhuis, Imeldalaan 9, Bonheiden 2820, Belgium

Hôpital St.-Joseph, Rue de la Duchère 6, Gilly B-6060, Belgium

Virga Jesse Ziekenhuis, Stadsomvaart 11, Hassel B - 3500, Belgium

Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105, Leuven B - 3000, Belgium

Clinique Sainte-Elisabet, Place Louise Godin 1, Namur B - 5000, Belgium

Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd, Burgas 8000, Bulgaria

Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str, Pleven 5800, Bulgaria

Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str, Ruse 7002, Bulgaria

Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd, Sofia 1202, Bulgaria

Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str, Sofia 1504, Bulgaria

Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str, Sofia 1606, Bulgaria

Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str, Sofia 1431, Bulgaria

Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd, Sofia 1606, Bulgaria

National Cardiology Hospital EAD, 65 Konjovitza Str., Sofia 1309, Bulgaria

CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd, Varna 9010, Bulgaria

Centre Hospitalier Général, 22, boulevard Général Sibille, Albi 81,000, France

Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill, Arras 62000, France

Philippe CHEMIN, 49 rue du Bocage, Bordeaux 33,200, France

Hopital d'instruction des armées, rue Colonel Fonferrier, Brest 29200, France

Centre Hospitalier Général, 516 avenue de Paris, Cambrai 59,407, France

Patrick GIRAUD, Bat C 132 av Gabriel Péri, Cavaillon 84300, France

André CORBIN, 28 rue du Conte de la Garaye, Dinan 22,100, France

Centre Hospitalier du Leman, 3 avenue de la dame, Evian-thonon 74203, France

Verschuersen Iordanka, 4 rue Béranger, Fontainebleau 77300, France

Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France, Freyming Merlebach 57 804, France

Centre Hospitalier Général, 10 rue de la Charité, Langres 52200, France

Jean Claude GICHTENAERE, 8 quai du Général Leclerc, Martigues 13,500, France

CHI Montfermeil, 10 rue du Gal Leclerc, Montfermeil 93370, France

Résidence Médicale Les Roses, 57, route de Lavérune, Montpellier 34070, France

Patrick KOHAN, 18 rue de la Commanderie, Nancy 54000, France

Centre Hospitalier Regional, 1 rue du Friscaty, Thionville 57126, France

Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne, Toulon 83,100, France

Centre médical, Promenade du petit Languedoc, Villefranche de Rouergue 12200, France

Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9, Bad Berka 99437, Germany

Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -, Bonn D53105, Germany

Klinikum Coburg , Ketschendorfer Str. 33, Coburg D-96450, Germany

Div Cardiology; University Hospital , Leipzigen St 44 -, Magdeburg 39120, Germany

Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,, Münster D-48129, Germany

Kardiologische Praxis, Magirusstr.49, Ulm D 89077, Germany

"Academisch Ziekenhuis Maastricht, P. Debyelaan 25, Maastricht 6229 HX, Netherlands

SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1, Brasov 500157, Romania

"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1, Bucuresti 011461, Romania

Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2, Bucuresti 020125, Romania

"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50, Cluj - Napoca 400347, Romania

Centrul de Cardiologie , Str. Tabaci No. 1, Craiova 200642, Romania

CARDIO EXPERT, Str. Romulus, Nr. 62., Timisoara 300203, Romania

Hospital Universitario de Getafe, Carretera de toledo, Madrid 28905, Spain

Additional Information


Last updated: February 21, 2007

Page last updated: August 23, 2015

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