Primary Objective: \- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: * Evaluate the rate of AF recurrences two months after randomization. * Assess the safety of the change from amiodarone to dronedarone * Assess dronedarone safety * Explore dronedarone and its active metabolite plasma level (in a subset of countries) * Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
AF recurrences
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
Time frame: one month after randomization
AF recurrences
Time frame: two months after randomization
Symptomatic bradycardia
Heart rate at rest \< 50 beats per minute
Time frame: two months after randomization
Tachycardia
Heart rate at rest \> 120 beats per minute
Time frame: two months after randomization
Dronedarone and amiodarone concentrations in plasma
Limited to a subset of countries
Time frame: 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 009
Adelaide, Australia
Investigational Site Number 013
Ballarat, Australia
Investigational Site Number 002
Garran, Australia
Investigational Site Number 007
Herston, Australia
Investigational Site Number 012
Hobart, Australia
Investigational Site Number 006
Liverpool, Australia
Investigational Site Number 010
Maroubra, Australia
Investigational Site Number 001
Nedlands, Australia
Investigational Site Number 004
New Lambton, Australia
Investigational Site Number 008
Redcliffe, Australia
...and 101 more locations