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

Status:

TERMINATED

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

Lead Sponsor:

MEDA Pharma GmbH & Co. KG

Collaborating Sponsors:

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

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...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

256 Patients enrolled

Trial Details

Trial ID

NCT00408473

Last Update

February 7 2022

Active Locations (47)

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Imeldaziekenhuis, Imeldalaan 9

Bonheiden, Belgium, 2820

Hôpital St.-Joseph, Rue de la Duchère 6

Gilly, Belgium, B-6060

Virga Jesse Ziekenhuis, Stadsomvaart 11

Hassel, Belgium, B - 3500