MedPath

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

Phase 4
Completed
Conditions
Atrial Fibrillation
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group ADRONEDARONEAmiodarone 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 BDRONEDARONEAmiodarone 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 CDRONEDARONEAmiodarone 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
NameTimeMethod
AF recurrencesone 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
NameTimeMethod
AF recurrencestwo months after randomization
Symptomatic bradycardiatwo months after randomization

Heart rate at rest \< 50 beats per minute

Tachycardiatwo months after randomization

Heart rate at rest \> 120 beats per minute

Dronedarone and amiodarone concentrations in plasma3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake

Limited to a subset of countries

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.