Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
- Registration Number
- NCT01140581
- Lead Sponsor
- Sanofi
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A DRONEDARONE Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks followed by dronedarone 400 mg twice daily for 8 weeks Group B DRONEDARONE Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks. Two weeks wash-out followed by dronedarone 400 mg twice daily for 6 weeks Group C DRONEDARONE Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks. Four weeks wash-out followed by dronedarone 400 mg twice daily for 4 weeks
- Primary Outcome Measures
Name Time Method AF recurrences one month after randomization two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
- Secondary Outcome Measures
Name Time Method AF recurrences two months after randomization Symptomatic bradycardia two months after randomization Heart rate at rest \< 50 beats per minute
Tachycardia two months after randomization Heart rate at rest \> 120 beats per minute
Dronedarone and amiodarone concentrations in plasma 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake Limited to a subset of countries
Related Research Topics
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Trial Locations
- Locations (111)
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
Scroll for more (101 remaining)Investigational Site Number 009🇦🇺Adelaide, Australia