A Randomized, International, Multi-center, Open-label Study to Document Optimal Timing of Initiation of Dronedarone Treatment After Conversion With Loading Dose of Amiodarone in Patients With Persistent Atrial Fibrillation Requiring Conversion of AF.
Overview
- Phase
- Phase 4
- Intervention
- DRONEDARONE
- Conditions
- Atrial Fibrillation
- Sponsor
- Sanofi
- Enrollment
- 402
- Locations
- 111
- Primary Endpoint
- AF recurrences
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group A
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
Intervention: DRONEDARONE
Group B
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
Intervention: DRONEDARONE
Group C
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
Intervention: DRONEDARONE
Outcomes
Primary Outcomes
AF recurrences
Time Frame: one month after randomization
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
Secondary Outcomes
- AF recurrences(two months after randomization)
- Symptomatic bradycardia(two months after randomization)
- Tachycardia(two months after randomization)
- Dronedarone and amiodarone concentrations in plasma(3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake)