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
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
AF recurrences	two months after randomization
Symptomatic bradycardia	two months after randomization	Heart rate at rest \< 50 beats per minute

Trial Locations

Locations (111)

Investigational Site Number 040-005; 🇦🇹 Wien, Austria

Investigational Site Number 276-001; 🇩🇪 Bonn, Germany

Investigational Site Number 040-004; 🇦🇹 Wien, Austria

Investigational Site Number 250-008; 🇫🇷 Lyon Cedex 03, France

Investigational Site Number 250-004; 🇫🇷 Toulouse Cedex 3, France

Investigational Site Number 276-006; 🇩🇪 Bernau, Germany

Investigational Site Number 380-005; 🇮🇹 Ancona, Italy

Investigational Site Number 380-012; 🇮🇹 Varese, Italy

Investigational Site Number 484015; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 410001; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 410004; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 276-004; 🇩🇪 Kiel, Germany

Investigational Site Number 276-003; 🇩🇪 Berlin, Germany

Investigational Site Number 040-006; 🇦🇹 Braunau, Austria

Investigational Site Number 246-004; 🇫🇮 Pori, Finland

Investigational Site Number 250-006; 🇫🇷 Avignon Cedex 9, France

Investigational Site Number 250-007; 🇫🇷 Cholet, France

Investigational Site Number 276-010; 🇩🇪 Frankfurt am Main, Germany

Investigational Site Number 380-006; 🇮🇹 Cortona, Italy

Investigational Site Number 380-011; 🇮🇹 Mestre, Italy

Investigational Site Number 276-008; 🇩🇪 Hamburg, Germany

Investigational Site Number 250-009; 🇫🇷 BEZIERS Cedex, France

Investigational Site Number 276-009; 🇩🇪 Heidenau, Germany

Investigational Site Number 040-007; 🇦🇹 Innsbruck, Austria

Investigational Site Number 040-001; 🇦🇹 Mödling, Austria

Investigational Site Number 246-001; 🇫🇮 Hyvinkää, Finland

Investigational Site Number 250-010; 🇫🇷 NIMES Cedex 9, France

Investigational Site Number 250-003; 🇫🇷 POITIERS Cedex, France

Investigational Site Number 250-001; 🇫🇷 Vandoeuvre Les Nancy, France

Investigational Site Number 276-011; 🇩🇪 Dresden, Germany

Investigational Site Number 380-009; 🇮🇹 San Daniele Del Friuli, Italy

Investigational Site Number 484012; 🇲🇽 Chihuahua, Mexico

Investigational Site Number 484016; 🇲🇽 Mexico, Mexico

Investigational Site Number 484001; 🇲🇽 Queretaro, Mexico

Investigational Site Number 528004; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 250-005; 🇫🇷 Valence Cedex 9, France

Investigational Site Number 276-007; 🇩🇪 Paderborn, Germany

Investigational Site Number 380-004; 🇮🇹 Catania, Italy

Investigational Site Number 410006; 🇰🇷 Suwon, Korea, Republic of

Investigational Site Number 484017; 🇲🇽 Aguascalientes, Mexico

Investigational Site Number 484009; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 484004; 🇲🇽 Mexico, Mexico

Investigational Site Number 484005; 🇲🇽 Monterrey, Mexico

Investigational Site Number 528002; 🇳🇱 Groningen, Netherlands

Investigational Site Number 756002; 🇨🇭 St.Gallen, Switzerland

Investigational Site Number 158005; 🇨🇳 Kaohsiung Hsien,, Taiwan

Investigational Site Number 380-007; 🇮🇹 Roma, Italy

Investigational Site Number 380-002; 🇮🇹 Barga, Italy

Investigational Site Number 484003; 🇲🇽 Monterrey, Mexico

Investigational Site Number 528001; 🇳🇱 Maastricht, Netherlands

Investigational Site Number 756001; 🇨🇭 Basel, Switzerland

Investigational Site Number 158004; 🇨🇳 Taichung, Taiwan

Investigational Site Number 410003; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 484008; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 484002; 🇲🇽 Leon, Mexico

Investigational Site Number 484011; 🇲🇽 Tijuana, Mexico

Investigational Site Number 620005; 🇵🇹 Amadora, Portugal

Investigational Site Number 620001; 🇵🇹 Lisboa, Portugal

Investigational Site Number 410005; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 158009; 🇨🇳 Taichung City, Taiwan

Investigational Site Number 158003; 🇨🇳 Taichung, Taiwan

Investigational Site Number 012; 🇦🇺 Hobart, Australia

Investigational Site Number 010; 🇦🇺 Maroubra, Australia

Investigational Site Number 001; 🇦🇺 Nedlands, Australia

Investigational Site Number 011; 🇦🇺 South Brisbane, Australia

Investigational Site Number 007; 🇦🇺 Herston, Australia

Investigational Site Number 009; 🇦🇺 Adelaide, Australia

Investigational Site Number 013; 🇦🇺 Ballarat, Australia

Investigational Site Number 002; 🇦🇺 Garran, Australia

Investigational Site Number 040-002; 🇦🇹 Linz, Austria

Investigational Site Number 246-002; 🇫🇮 Hyvinkää, Finland

Investigational Site Number 040-003; 🇦🇹 Vienna, Austria

Investigational Site Number 380-010; 🇮🇹 Palermo, Italy

Investigational Site Number 380-003; 🇮🇹 Roma, Italy

Investigational Site Number 410002; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 484013; 🇲🇽 Saltillo, Mexico

Investigational Site Number 826-005; 🇬🇧 Bournemouth, United Kingdom

Investigational Site Number 724009; 🇪🇸 Valencia, Spain

Investigational Site Number 724007; 🇪🇸 Tarragona, Spain

Investigational Site Number 158002; 🇨🇳 Taipei, Taiwan

Investigational Site Number 826-002; 🇬🇧 Gloucester, United Kingdom

Investigational Site Number 158001; 🇨🇳 Taipei, Taiwan

Investigational Site Number 158008; 🇨🇳 Taipei, Taiwan

Investigational Site Number 006; 🇦🇺 Liverpool, Australia

Investigational Site Number 004; 🇦🇺 New Lambton, Australia

Investigational Site Number 008; 🇦🇺 Redcliffe, Australia

Investigational Site Number 005; 🇦🇺 Southport, Australia

Investigational Site Number 003; 🇦🇺 Woolloongabba, Australia

Investigational Site Number 233001; 🇪🇪 Tallinn, Estonia

Investigational Site Number 246-003; 🇫🇮 Seinäjoki, Finland

Investigational Site Number 250-002; 🇫🇷 Bron, France

Investigational Site Number 276-002; 🇩🇪 Hamburg, Germany

Investigational Site Number 276-005; 🇩🇪 Ludwigsburg, Germany

Investigational Site Number 376002; 🇮🇱 Ashkelon, Israel

Investigational Site Number 376001; 🇮🇱 Beer Yaakov, Israel

Investigational Site Number 380-001; 🇮🇹 Como, Italy

Investigational Site Number 528003; 🇳🇱 Amsterdam, Netherlands

Investigational Site Number 528005; 🇳🇱 Goes, Netherlands

Investigational Site Number 724004; 🇪🇸 El Palmar (MURCIA), Spain

Investigational Site Number 724005; 🇪🇸 Hospitalet de Llobregat, Spain

Investigational Site Number 724003; 🇪🇸 LLeida, Spain

Investigational Site Number 724001; 🇪🇸 Madrid, Spain

Investigational Site Number 724008; 🇪🇸 La Coruña, Spain

Investigational Site Number 724010; 🇪🇸 Madrid, Spain

Investigational Site Number 724006; 🇪🇸 Sevilla, Spain

Investigational Site Number 724002; 🇪🇸 Majadahonda, Spain

Investigational Site Number 158006; 🇨🇳 Kaohsiung, Taiwan

Investigational Site Number 158007; 🇨🇳 Tao Yuan Hsien, Taiwan

Investigational Site Number 826006; 🇬🇧 Belfast, United Kingdom

Investigational Site Number 826-007; 🇬🇧 Wrexham, United Kingdom

Investigational Site Number 826-001; 🇬🇧 Carshalton, United Kingdom