A Randomized Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients with a Documented First Episode of Atrial Fibrillation. - FLEC-PO-NA-CACR-06-MC-M

• Conditions: Atrial Fibrillation.; MedDRA version: 8.1Level: LLTClassification code 10003658Term: Atrial fibrillation

• Registration Number: EUCTR2006-003211-40-BE
• Lead Sponsor: aboratoires 3M Santé

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-15
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

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 < 7 days which occurred during the 5 weeks prior to inclusion visit and terminated spontaneously or with medical treatment.
(*This episode should be the first and only one known and documented AF episode”. Symptom(s) should have been present for at least 1hour prior to and during the event record.)
5. Patient not on AAD at the time of recruitment
6. Patient must be in sinus rhythm at the time of treatment initiation.
7. Left ventricular ejection fraction > 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

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 < 40 beats/min and all ECG abnormalities: PR> 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>To assess safety of flecainide CR over 9 months of treatment. <br>;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.<br>The recurrence will be defined as an AF episode with a duration of equal to or greater than 30 seconds.<br>