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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Flecainide
Sponsored by
MEDA Pharma GmbH & Co. KG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imeldaziekenhuis, Imeldalaan 9
  • Hôpital St.-Joseph, Rue de la Duchère 6
  • Virga Jesse Ziekenhuis, Stadsomvaart 11
  • Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
  • Clinique Sainte-Elisabet, Place Louise Godin 1
  • Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
  • Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
  • Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
  • Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
  • National Cardiology Hospital EAD, 65 Konjovitza Str.
  • Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
  • Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
  • Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
  • Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
  • CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
  • Centre Hospitalier Général, 22, boulevard Général Sibille
  • Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
  • Philippe CHEMIN, 49 rue du Bocage
  • Hopital d'instruction des armées, rue Colonel Fonferrier
  • Centre Hospitalier Général, 516 avenue de Paris
  • Patrick GIRAUD, Bat C 132 av Gabriel Péri
  • André CORBIN, 28 rue du Conte de la Garaye
  • Centre Hospitalier du Leman, 3 avenue de la dame
  • Verschuersen Iordanka, 4 rue Béranger
  • Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
  • Centre Hospitalier Général, 10 rue de la Charité
  • Jean Claude GICHTENAERE, 8 quai du Général Leclerc
  • CHI Montfermeil, 10 rue du Gal Leclerc
  • Résidence Médicale Les Roses, 57, route de Lavérune
  • Patrick KOHAN, 18 rue de la Commanderie
  • Centre Hospitalier Regional, 1 rue du Friscaty
  • Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
  • Centre médical, Promenade du petit Languedoc
  • Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
  • Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
  • Klinikum Coburg , Ketschendorfer Str. 33
  • Div Cardiology; University Hospital , Leipzigen St 44 -
  • Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
  • Kardiologische Praxis, Magirusstr.49
  • "Academisch Ziekenhuis Maastricht, P. Debyelaan 25
  • SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
  • "SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
  • Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
  • "SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
  • Centrul de Cardiologie , Str. Tabaci No. 1
  • CARDIO EXPERT, Str. Romulus, Nr. 62.
  • Hospital Universitario de Getafe, Carretera de toledo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2006
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00408473
Brief Title
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

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MEDA Pharma GmbH & Co. KG
Collaborators
3M

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
256 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flecainide
Primary Outcome Measure Information:
Title
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
Secondary Outcome Measure Information:
Title
Total number of AF recurrences during the treatment period
Title
Total number of patients in sinus rhythm at the end of the study
Title
AF Burden
Title
Number of emergency admissions due to AF recurrence
Title
Cardiac Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof E Aliot
Organizational Affiliation
CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imeldaziekenhuis, Imeldalaan 9
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Hôpital St.-Joseph, Rue de la Duchère 6
City
Gilly
ZIP/Postal Code
B-6060
Country
Belgium
Facility Name
Virga Jesse Ziekenhuis, Stadsomvaart 11
City
Hassel
ZIP/Postal Code
B - 3500
Country
Belgium
Facility Name
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
City
Leuven
ZIP/Postal Code
B - 3000
Country
Belgium
Facility Name
Clinique Sainte-Elisabet, Place Louise Godin 1
City
Namur
ZIP/Postal Code
B - 5000
Country
Belgium
Facility Name
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
National Cardiology Hospital EAD, 65 Konjovitza Str.
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Centre Hospitalier Général, 22, boulevard Général Sibille
City
Albi
ZIP/Postal Code
81,000
Country
France
Facility Name
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
Philippe CHEMIN, 49 rue du Bocage
City
Bordeaux
ZIP/Postal Code
33,200
Country
France
Facility Name
Hopital d'instruction des armées, rue Colonel Fonferrier
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Hospitalier Général, 516 avenue de Paris
City
Cambrai
ZIP/Postal Code
59,407
Country
France
Facility Name
Patrick GIRAUD, Bat C 132 av Gabriel Péri
City
Cavaillon
ZIP/Postal Code
84300
Country
France
Facility Name
André CORBIN, 28 rue du Conte de la Garaye
City
Dinan
ZIP/Postal Code
22,100
Country
France
Facility Name
Centre Hospitalier du Leman, 3 avenue de la dame
City
Evian-thonon
ZIP/Postal Code
74203
Country
France
Facility Name
Verschuersen Iordanka, 4 rue Béranger
City
Fontainebleau
ZIP/Postal Code
77300
Country
France
Facility Name
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
City
Freyming Merlebach
ZIP/Postal Code
57 804
Country
France
Facility Name
Centre Hospitalier Général, 10 rue de la Charité
City
Langres
ZIP/Postal Code
52200
Country
France
Facility Name
Jean Claude GICHTENAERE, 8 quai du Général Leclerc
City
Martigues
ZIP/Postal Code
13,500
Country
France
Facility Name
CHI Montfermeil, 10 rue du Gal Leclerc
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Résidence Médicale Les Roses, 57, route de Lavérune
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Patrick KOHAN, 18 rue de la Commanderie
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Centre Hospitalier Regional, 1 rue du Friscaty
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
City
Toulon
ZIP/Postal Code
83,100
Country
France
Facility Name
Centre médical, Promenade du petit Languedoc
City
Villefranche de Rouergue
ZIP/Postal Code
12200
Country
France
Facility Name
Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
City
Bonn
ZIP/Postal Code
D53105
Country
Germany
Facility Name
Klinikum Coburg , Ketschendorfer Str. 33
City
Coburg
ZIP/Postal Code
D-96450
Country
Germany
Facility Name
Div Cardiology; University Hospital , Leipzigen St 44 -
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
City
Münster
ZIP/Postal Code
D-48129
Country
Germany
Facility Name
Kardiologische Praxis, Magirusstr.49
City
Ulm
ZIP/Postal Code
D 89077
Country
Germany
Facility Name
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
City
Brasov
ZIP/Postal Code
500157
Country
Romania
Facility Name
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
City
Bucuresti
ZIP/Postal Code
011461
Country
Romania
Facility Name
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
City
Cluj - Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Centrul de Cardiologie , Str. Tabaci No. 1
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
CARDIO EXPERT, Str. Romulus, Nr. 62.
City
Timisoara
ZIP/Postal Code
300203
Country
Romania
Facility Name
Hospital Universitario de Getafe, Carretera de toledo
City
Madrid
ZIP/Postal Code
28905
Country
Spain

12. IPD Sharing Statement

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

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