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Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation (ARTEMIS Load)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DRONEDARONE
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Screening:

  • Persistent AF for more than 72 hours (documented by an ECG taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the Investigator
  • Naive of amiodarone treatment in the last three months
  • QTc Bazett < 500 ms on 12-lead ECG,
  • At least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter >= 50 mm

Randomization:

  • Outpatient and Inpatients (except patients hospitalized during screening period for SAE)
  • Sinus rhythm
  • Effective oral anticoagulation verified by International Normalized Ratio/INR (target > 2)
  • QTc Bazett < 500 ms and PR < 280 ms on 12-lead ECG
  • Completed treatment period with amiodarone (28 days ± 2 days)

Exclusion criteria:

Screening:

  • Contraindication to oral anticoagulation
  • Acute condition known to cause AF
  • Permanent AF
  • Paroxysmal AF
  • Bradycardia < 50 bpm on the 12-lead ECG

  • Clinically overt congestive heart failure:

    • with New York Heart Association (NYHA) classes III and IV heart failure
    • with LVEF < 35%
    • or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
    • or unstable hemodynamic conditions
  • Severe hepatic impairment
  • Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week
  • Previous history of amiodarone intolerance or toxicity
  • Any contraindication as per dronedarone and amiodarone labelling
  • Wolff-Parkinson-White Syndrome
  • Previous ablation for atrial fibrillation or any planned ablation in the next 2 months

  • Contraindicated concomitant treatment:

    • Potent cytochrome P450 (CYP3A4) inhibitors
    • Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes
    • Class I or III anti-arrhythmic drugs (including sotalol)

Randomization:

  • Bradycardia < 50 bpm on the 12-lead ECG

  • Clinically overt congestive heart failure:

    • with New York Heart Association (NYHA) classes III and IV heart failure
    • with LVEF < 35%
    • or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
    • or unstable hemodynamic conditions
  • Severe hepatic impairment
  • Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week

  • Patient in whom the following contraindicated concomitant treatment is mandatory:

    • Potent cytochrome P450 (CYP3A4) inhibitors
    • Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes
    • Class I or III anti-arrhythmic drugs (including sotalol)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 009
  • Investigational Site Number 013
  • Investigational Site Number 002
  • Investigational Site Number 007
  • Investigational Site Number 012
  • Investigational Site Number 006
  • Investigational Site Number 010
  • Investigational Site Number 001
  • Investigational Site Number 004
  • Investigational Site Number 008
  • Investigational Site Number 011
  • Investigational Site Number 005
  • Investigational Site Number 003
  • Investigational Site Number 040-006
  • Investigational Site Number 040-007
  • Investigational Site Number 040-002
  • Investigational Site Number 040-001
  • Investigational Site Number 040-003
  • Investigational Site Number 040-005
  • Investigational Site Number 040-004
  • Investigational Site Number 233001
  • Investigational Site Number 246-001
  • Investigational Site Number 246-002
  • Investigational Site Number 246-004
  • Investigational Site Number 246-003
  • Investigational Site Number 250-006
  • Investigational Site Number 250-009
  • Investigational Site Number 250-002
  • Investigational Site Number 250-007
  • Investigational Site Number 250-008
  • Investigational Site Number 250-010
  • Investigational Site Number 250-003
  • Investigational Site Number 250-004
  • Investigational Site Number 250-005
  • Investigational Site Number 250-001
  • Investigational Site Number 276-003
  • Investigational Site Number 276-006
  • Investigational Site Number 276-001
  • Investigational Site Number 276-011
  • Investigational Site Number 276-010
  • Investigational Site Number 276-002
  • Investigational Site Number 276-008
  • Investigational Site Number 276-009
  • Investigational Site Number 276-004
  • Investigational Site Number 276-005
  • Investigational Site Number 276-007
  • Investigational Site Number 376002
  • Investigational Site Number 376001
  • Investigational Site Number 380-005
  • Investigational Site Number 380-002
  • Investigational Site Number 380-004
  • Investigational Site Number 380-001
  • Investigational Site Number 380-006
  • Investigational Site Number 380-011
  • Investigational Site Number 380-010
  • Investigational Site Number 380-007
  • Investigational Site Number 380-003
  • Investigational Site Number 380-009
  • Investigational Site Number 380-012
  • Investigational Site Number 410001
  • Investigational Site Number 410002
  • Investigational Site Number 410003
  • Investigational Site Number 410004
  • Investigational Site Number 410005
  • Investigational Site Number 410006
  • Investigational Site Number 484017
  • Investigational Site Number 484012
  • Investigational Site Number 484008
  • Investigational Site Number 484009
  • Investigational Site Number 484015
  • Investigational Site Number 484002
  • Investigational Site Number 484016
  • Investigational Site Number 484004
  • Investigational Site Number 484005
  • Investigational Site Number 484003
  • Investigational Site Number 484001
  • Investigational Site Number 484013
  • Investigational Site Number 484011
  • Investigational Site Number 528003
  • Investigational Site Number 528005
  • Investigational Site Number 528002
  • Investigational Site Number 528001
  • Investigational Site Number 528004
  • Investigational Site Number 620005
  • Investigational Site Number 620001
  • Investigational Site Number 724004
  • Investigational Site Number 724005
  • Investigational Site Number 724008
  • Investigational Site Number 724003
  • Investigational Site Number 724010
  • Investigational Site Number 724001
  • Investigational Site Number 724002
  • Investigational Site Number 724006
  • Investigational Site Number 724007
  • Investigational Site Number 724009
  • Investigational Site Number 756001
  • Investigational Site Number 756002
  • Investigational Site Number 158005
  • Investigational Site Number 158006
  • Investigational Site Number 158009
  • Investigational Site Number 158004
  • Investigational Site Number 158003
  • Investigational Site Number 158002
  • Investigational Site Number 158001
  • Investigational Site Number 158008
  • Investigational Site Number 158007
  • Investigational Site Number 826006
  • Investigational Site Number 826-005
  • Investigational Site Number 826-001
  • Investigational Site Number 826-002
  • Investigational Site Number 826-007

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

AF recurrences
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF

Secondary Outcome Measures

AF recurrences
Symptomatic bradycardia
Heart rate at rest < 50 beats per minute
Tachycardia
Heart rate at rest > 120 beats per minute
Dronedarone and amiodarone concentrations in plasma
Limited to a subset of countries

Full Information

First Posted
June 8, 2010
Last Updated
January 20, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01140581
Brief Title
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
Acronym
ARTEMIS Load
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Arm Title
Group C
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
DRONEDARONE
Intervention Description
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
Primary Outcome Measure Information:
Title
AF recurrences
Description
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
Time Frame
one month after randomization
Secondary Outcome Measure Information:
Title
AF recurrences
Time Frame
two months after randomization
Title
Symptomatic bradycardia
Description
Heart rate at rest < 50 beats per minute
Time Frame
two months after randomization
Title
Tachycardia
Description
Heart rate at rest > 120 beats per minute
Time Frame
two months after randomization
Title
Dronedarone and amiodarone concentrations in plasma
Description
Limited to a subset of countries
Time Frame
3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Screening: Persistent AF for more than 72 hours (documented by an ECG taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the Investigator Naive of amiodarone treatment in the last three months QTc Bazett < 500 ms on 12-lead ECG, At least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter >= 50 mm Randomization: Outpatient and Inpatients (except patients hospitalized during screening period for SAE) Sinus rhythm Effective oral anticoagulation verified by International Normalized Ratio/INR (target > 2) QTc Bazett < 500 ms and PR < 280 ms on 12-lead ECG Completed treatment period with amiodarone (28 days ± 2 days) Exclusion criteria: Screening: Contraindication to oral anticoagulation Acute condition known to cause AF Permanent AF Paroxysmal AF Bradycardia < 50 bpm on the 12-lead ECG Clinically overt congestive heart failure: with New York Heart Association (NYHA) classes III and IV heart failure with LVEF < 35% or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic or unstable hemodynamic conditions Severe hepatic impairment Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week Previous history of amiodarone intolerance or toxicity Any contraindication as per dronedarone and amiodarone labelling Wolff-Parkinson-White Syndrome Previous ablation for atrial fibrillation or any planned ablation in the next 2 months Contraindicated concomitant treatment: Potent cytochrome P450 (CYP3A4) inhibitors Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes Class I or III anti-arrhythmic drugs (including sotalol) Randomization: Bradycardia < 50 bpm on the 12-lead ECG Clinically overt congestive heart failure: with New York Heart Association (NYHA) classes III and IV heart failure with LVEF < 35% or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic or unstable hemodynamic conditions Severe hepatic impairment Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week Patient in whom the following contraindicated concomitant treatment is mandatory: Potent cytochrome P450 (CYP3A4) inhibitors Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes Class I or III anti-arrhythmic drugs (including sotalol) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 009
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Investigational Site Number 013
City
Ballarat
ZIP/Postal Code
3350
Country
Australia
Facility Name
Investigational Site Number 002
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Investigational Site Number 007
City
Herston
ZIP/Postal Code
4006
Country
Australia
Facility Name
Investigational Site Number 012
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Investigational Site Number 006
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Investigational Site Number 010
City
Maroubra
ZIP/Postal Code
2035
Country
Australia
Facility Name
Investigational Site Number 001
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Investigational Site Number 004
City
New Lambton
ZIP/Postal Code
2305
Country
Australia
Facility Name
Investigational Site Number 008
City
Redcliffe
ZIP/Postal Code
4020
Country
Australia
Facility Name
Investigational Site Number 011
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Investigational Site Number 005
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Investigational Site Number 003
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Investigational Site Number 040-006
City
Braunau
ZIP/Postal Code
5280
Country
Austria
Facility Name
Investigational Site Number 040-007
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Investigational Site Number 040-002
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Investigational Site Number 040-001
City
Mödling
ZIP/Postal Code
2340
Country
Austria
Facility Name
Investigational Site Number 040-003
City
Vienna
Country
Austria
Facility Name
Investigational Site Number 040-005
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number 040-004
City
Wien
Country
Austria
Facility Name
Investigational Site Number 233001
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Investigational Site Number 246-001
City
Hyvinkää
ZIP/Postal Code
05850
Country
Finland
Facility Name
Investigational Site Number 246-002
City
Hyvinkää
ZIP/Postal Code
05850
Country
Finland
Facility Name
Investigational Site Number 246-004
City
Pori
ZIP/Postal Code
28210
Country
Finland
Facility Name
Investigational Site Number 246-003
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Investigational Site Number 250-006
City
Avignon Cedex 9
ZIP/Postal Code
84902
Country
France
Facility Name
Investigational Site Number 250-009
City
BEZIERS Cedex
ZIP/Postal Code
34525
Country
France
Facility Name
Investigational Site Number 250-002
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Investigational Site Number 250-007
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Investigational Site Number 250-008
City
Lyon Cedex 03
ZIP/Postal Code
69275
Country
France
Facility Name
Investigational Site Number 250-010
City
NIMES Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number 250-003
City
POITIERS Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Investigational Site Number 250-004
City
Toulouse Cedex 3
ZIP/Postal Code
31076
Country
France
Facility Name
Investigational Site Number 250-005
City
Valence Cedex 9
ZIP/Postal Code
26953
Country
France
Facility Name
Investigational Site Number 250-001
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number 276-003
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Investigational Site Number 276-006
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Investigational Site Number 276-001
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Investigational Site Number 276-011
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Investigational Site Number 276-010
City
Frankfurt am Main
ZIP/Postal Code
60594
Country
Germany
Facility Name
Investigational Site Number 276-002
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Facility Name
Investigational Site Number 276-008
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Investigational Site Number 276-009
City
Heidenau
ZIP/Postal Code
01809
Country
Germany
Facility Name
Investigational Site Number 276-004
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Investigational Site Number 276-005
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Investigational Site Number 276-007
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Investigational Site Number 376002
City
Ashkelon
Country
Israel
Facility Name
Investigational Site Number 376001
City
Beer Yaakov
Country
Israel
Facility Name
Investigational Site Number 380-005
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Investigational Site Number 380-002
City
Barga
ZIP/Postal Code
55051
Country
Italy
Facility Name
Investigational Site Number 380-004
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Investigational Site Number 380-001
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Investigational Site Number 380-006
City
Cortona
ZIP/Postal Code
52042
Country
Italy
Facility Name
Investigational Site Number 380-011
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Investigational Site Number 380-010
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Investigational Site Number 380-007
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Investigational Site Number 380-003
City
Roma
ZIP/Postal Code
00169
Country
Italy
Facility Name
Investigational Site Number 380-009
City
San Daniele Del Friuli
ZIP/Postal Code
33038
Country
Italy
Facility Name
Investigational Site Number 380-012
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Investigational Site Number 410001
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 410005
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Investigational Site Number 484017
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Investigational Site Number 484012
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Investigational Site Number 484008
City
Guadalajara
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Investigational Site Number 484009
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Investigational Site Number 484015
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Investigational Site Number 484002
City
Leon
ZIP/Postal Code
37150
Country
Mexico
Facility Name
Investigational Site Number 484016
City
Mexico
ZIP/Postal Code
06140
Country
Mexico
Facility Name
Investigational Site Number 484004
City
Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Investigational Site Number 484005
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Investigational Site Number 484013
City
Saltillo
ZIP/Postal Code
25230
Country
Mexico
Facility Name
Investigational Site Number 484011
City
Tijuana
ZIP/Postal Code
22450
Country
Mexico
Facility Name
Investigational Site Number 528003
City
Amsterdam
Country
Netherlands
Facility Name
Investigational Site Number 528005
City
Goes
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Groningen
Country
Netherlands
Facility Name
Investigational Site Number 528001
City
Maastricht
Country
Netherlands
Facility Name
Investigational Site Number 528004
City
Rotterdam
Country
Netherlands
Facility Name
Investigational Site Number 620005
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Investigational Site Number 620001
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Investigational Site Number 724004
City
El Palmar (MURCIA)
ZIP/Postal Code
30120
Country
Spain
Facility Name
Investigational Site Number 724005
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724008
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 724003
City
LLeida
Country
Spain
Facility Name
Investigational Site Number 724010
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number 724001
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724002
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Investigational Site Number 724006
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Investigational Site Number 724007
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Investigational Site Number 724009
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Investigational Site Number 756001
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Investigational Site Number 756002
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Investigational Site Number 158005
City
Kaohsiung Hsien,
Country
Taiwan
Facility Name
Investigational Site Number 158006
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Investigational Site Number 158009
City
Taichung City
Country
Taiwan
Facility Name
Investigational Site Number 158004
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Investigational Site Number 158003
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Investigational Site Number 158002
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number 158001
City
Taipei
Country
Taiwan
Facility Name
Investigational Site Number 158008
City
Taipei
Country
Taiwan
Facility Name
Investigational Site Number 158007
City
Tao Yuan Hsien
Country
Taiwan
Facility Name
Investigational Site Number 826006
City
Belfast
ZIP/Postal Code
BT126BA
Country
United Kingdom
Facility Name
Investigational Site Number 826-005
City
Bournemouth
ZIP/Postal Code
BH77DW
Country
United Kingdom
Facility Name
Investigational Site Number 826-001
City
Carshalton
ZIP/Postal Code
SM51AA
Country
United Kingdom
Facility Name
Investigational Site Number 826-002
City
Gloucester
ZIP/Postal Code
GL13NN
Country
United Kingdom
Facility Name
Investigational Site Number 826-007
City
Wrexham
ZIP/Postal Code
LL137TD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32500725
Citation
Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brule L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.
Results Reference
derived

Learn more about this trial

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

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