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

Phase 4

Terminated

• Conditions: Atrial Fibrillation

• Registration Number: NCT00408473
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

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

Not available

Study Timeline

• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Status Verified: 2007-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of emergency admissions due to AF recurrence
Cardiac Safety
Total number of AF recurrences during the treatment period
Total number of patients in sinus rhythm at the end of the study
AF Burden

Trial Locations

Locations (47)

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, Belgium

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

National Cardiology Hospital EAD, 65 Konjovitza Str.; 🇧🇬 Sofia, Bulgaria

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