Atrial Fibrillation. MedDRA version: 8.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Trade Name: Apocard Retard 100 mg
Product Name: Flecainide acetate CR
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Flecainide
CAS Number: 54143565
Current Sponsor code: R
Sponsors
Laboratoires 3M Santé
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible for participation in the study if the following inclusion criteria are met: 1. Willing to participate in the study, 2. Age between 18 and 65 years, 3. Willing to attend 10 outpatient visit during the course of the clinical study and to comply with the study requirements such as willing to undergo at least 8 ECGs, 3 Holters, and at least 2 weekly self ECG unit (heart scan) evaluations 4. History of one only symptomatic* and documented AF episode with duration > 1h and 40%, evaluated by a transthoracic echocardiogram, performed at the inclusion visit. 8. Females of child bearing potential must have a negative urine pregnancy test at the inclusion visit and at the end of study visits and be willing to use a medically acceptable method of contraception during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if any of the following apply: 1. History of more than one symptomatic documented AF episode 2. Persistent or permanent AF. 3. History of ablation for previous AF. 4. Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery). 5. Severe symptoms during AF episode (e.g.syncope, chest pain). 6. All types of treated arrhythmias other than AF 7. 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. 8. Left ventricular ejection fraction (LVEF) = 40%, 9. Bradycardia 240ms or QRS> 120 ms or QTc> 440 ms, 10. Brugada symdrome, 11. Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block 12. 2nd or 3rd degree atrio ventricular block (AV block). 13. Sinus node dysfunction. 14. Severe hypertension with: • Systolic blood pressure = 180 mmHg, and / or • Diastolic blood pressure = 100 mmHg, 15. Left ventricular hypertrophy with septal thickness > 14 mm on Echocardiogram. 16. Implanted pacemaker. 17. Heart surgery within the last 6 months, or non stable postoperative condition, 18. Renal failure: serum creatinine = 150 µmol/l or creatinine clearance = 50 ml/min (Cockroft and Gault formula), 19. Uncorrected electrolytic abnormalities, 20. Have used recently in the last 3 months prior to the inclusion any of the following treatments: - Oral amiodarone, - Treatment that lengthen QT (for example: Sultopride) - Drugs causing torsades de pointe (e.g. mizolastine, pentamidine, sparfloxacin, moxifloxacin) - Bupropion 21. Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB). 22. Unable to read and understand study documents and/or cognitive or sensory limitations. 23. Are currently participating in another clinical study (with or without an investigational drug).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this 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.;Secondary Objective: To assess the relevance of rhythm control management of first time AF, by comparing number of patients in sinus rhythm and who are still on the randomized regimen at the end of follow-up. To assess safety of flecainide CR over 9 months of treatment. ;Primary end point(s): The primary efficacy variable will be the time to the first AF episode relapse, with or without symptoms, documented by ECG, Holter or Heart Scan recordings, during the 9-month treatment. The recurrence will be defined as an AF episode with a duration of equal to or greater than 30 seconds. | — |
Countries
Belgium
Outcome results
None listed