Atrial Fibrillation Clinical Trial
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.
| NCT number | NCT00408473 |
| Other study ID # | 1556-FLEC |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 4 |
| First received | |
| Last updated |
| Verified date | February 2007 |
| Source | Viatris Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 256 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | 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 | |
| Bulgaria | 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 | Ruse | |
| Bulgaria | 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 | Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str | Sofia | |
| Bulgaria | Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str | Sofia | |
| Bulgaria | Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd | Sofia | |
| Bulgaria | National Cardiology Hospital EAD, 65 Konjovitza Str. | Sofia | |
| Bulgaria | CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd | Varna | |
| France | 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 | |
| Germany | 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 | |
| Netherlands | "Academisch Ziekenhuis Maastricht, P. Debyelaan 25 | Maastricht | |
| Romania | 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 | Bucuresti | |
| Romania | Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2 | Bucuresti | |
| 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. | Timisoara | |
| Spain | Hospital Universitario de Getafe, Carretera de toledo | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| MEDA Pharma GmbH & Co. KG | 3M |
Belgium, Bulgaria, France, Germany, Netherlands, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording. | |||
| Secondary | Total number of AF recurrences during the treatment period | |||
| Secondary | Total number of patients in sinus rhythm at the end of the study | |||
| Secondary | AF Burden | |||
| Secondary | Number of emergency admissions due to AF recurrence | |||
| Secondary | Cardiac Safety |
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