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

Tracking Information

First Received Date ^ICMJE

December 6, 2006

Last Updated Date

February 21, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00408473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Flecainide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

256

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Bulgaria, France, Germany, Netherlands, Romania, Spain

Administrative Information

NCT ID ^ICMJE

NCT00408473

Responsible Party

Study ID Numbers ^ICMJE

1556-FLEC

Study Sponsor ^ICMJE

MEDA Pharma GmbH & Co. KG

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Prof E Aliot

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

Information Provided By

MEDA Pharma GmbH & Co. KG

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP