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

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: DRONEDARONE

• 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

Study Timeline

• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Study Start: 2010-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

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

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

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

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