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

NCT00408473 | Terminated Phase 4

• 1 other identifier: 1556-FLEC
• Study Type: interventional
• Target: 256
• Locations: 7 countries
• Sites: 47

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

Flecainide DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of first symptomatic \& documented episode of AF
• LVEF \> 40% and not on AAD and in sinus rhythm at time of recruitment

You may not qualify if:

• 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
• nd 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

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead
• 3M: collaborator

Study Sites (47)

Imeldaziekenhuis, Imeldalaan 9

Bonheiden, 2820, Belgium

Location

Hôpital St.-Joseph, Rue de la Duchère 6

Gilly, B-6060, Belgium

Location

Virga Jesse Ziekenhuis, Stadsomvaart 11

Hassel, B - 3500, Belgium

Location

Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105

Leuven, B - 3000, Belgium

Location

Clinique Sainte-Elisabet, Place Louise Godin 1

Namur, B - 5000, Belgium

Location

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

Burgas, 8000, Bulgaria

Location

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

Pleven, 5800, Bulgaria

Location

Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str

Rousse, 7002, Bulgaria

Location

Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd

Sofia, 1202, Bulgaria

Location

National Cardiology Hospital EAD, 65 Konjovitza Str.

Sofia, 1309, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

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

Sofia, 1504, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd

Sofia, 1606, Bulgaria

Location

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

Varna, 9010, Bulgaria

Location

Centre Hospitalier Général, 22, boulevard Général Sibille

Albi, 81,000, France

Location

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

Arras, 62000, France

Location

Philippe CHEMIN, 49 rue du Bocage

Bordeaux, 33,200, France

Location

Hopital d'instruction des armées, rue Colonel Fonferrier

Brest, 29200, France

Location

Centre Hospitalier Général, 516 avenue de Paris

Cambrai, 59,407, France

Location

Patrick GIRAUD, Bat C 132 av Gabriel Péri

Cavaillon, 84300, France

Location

André CORBIN, 28 rue du Conte de la Garaye

Dinan, 22,100, France

Location

Centre Hospitalier du Leman, 3 avenue de la dame

Evian-thonon, 74203, France

Location

Verschuersen Iordanka, 4 rue Béranger

Fontainebleau, 77300, France

Location

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

Freyming-Merlebach, 57 804, France

Location

Centre Hospitalier Général, 10 rue de la Charité

Langres, 52200, France

Location

Jean Claude GICHTENAERE, 8 quai du Général Leclerc

Martigues, 13,500, France

Location

CHI Montfermeil, 10 rue du Gal Leclerc

Montfermeil, 93370, France

Location

Résidence Médicale Les Roses, 57, route de Lavérune

Montpellier, 34070, France

Location

Patrick KOHAN, 18 rue de la Commanderie

Nancy, 54000, France

Location

Centre Hospitalier Regional, 1 rue du Friscaty

Thionville, 57126, France

Location

Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne

Toulon, 83,100, France

Location

Centre médical, Promenade du petit Languedoc

Villefranche-de-Rouergue, 12200, France

Location

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

Bad Berka, 99437, Germany

Location

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

Bonn, D53105, Germany

Location

Klinikum Coburg , Ketschendorfer Str. 33

Coburg, D-96450, Germany

Location

Div Cardiology; University Hospital , Leipzigen St 44 -

Magdeburg, 39120, Germany

Location

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

Münster, D-48129, Germany

Location

Kardiologische Praxis, Magirusstr.49

Ulm, D 89077, Germany

Location

"Academisch Ziekenhuis Maastricht, P. Debyelaan 25

Maastricht, 6229 HX, Netherlands

Location

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

Brasov, 500157, Romania

Location

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

Bucharest, 011461, Romania

Location

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

Bucharest, 020125, Romania

Location

"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50

Cluj-Napoca, 400347, Romania

Location

Centrul de Cardiologie , Str. Tabaci No. 1

Craiova, 200642, Romania

Location

CARDIO EXPERT, Str. Romulus, Nr. 62.

Timișoara, 300203, Romania

Location

Hospital Universitario de Getafe, Carretera de toledo

Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Prof E Aliot

  CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Last Updated: February 7, 2022

Record last verified: 2007-02

Locations

RO (6); BE (5); FR (18); NL (1); BU (10); ES (1); DE (6)