Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
This study has been terminated.
Information provided by:
MEDA Pharma GmbH & Co. KG
First received: December 6, 2006
Last updated: February 21, 2007
Last verified: February 2007
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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.
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
| Estimated Enrollment:
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- History of first symptomatic & documented episode of AF
- LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00408473
MEDA Pharma GmbH & Co. KG
||Prof E Aliot
||CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 6, 2006
||February 21, 2007
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014