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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01140581




Registration number
NCT01140581
Ethics application status
Date submitted
8/06/2010
Date registered
9/06/2010
Date last updated
23/01/2012

Titles & IDs
Public title
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
Scientific 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.
Secondary ID [1] 0 0
2009-016818-24
Secondary ID [2] 0 0
DRONE_C_03668
Universal Trial Number (UTN)
Trial acronym
ARTEMIS Load
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DRONEDARONE

Experimental: 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

Experimental: 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

Experimental: 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


Treatment: Drugs: DRONEDARONE
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AF recurrences
Timepoint [1] 0 0
one month after randomization
Secondary outcome [1] 0 0
AF recurrences
Timepoint [1] 0 0
two months after randomization
Secondary outcome [2] 0 0
Symptomatic bradycardia
Timepoint [2] 0 0
two months after randomization
Secondary outcome [3] 0 0
Tachycardia
Timepoint [3] 0 0
two months after randomization
Secondary outcome [4] 0 0
Dronedarone and amiodarone concentrations in plasma
Timepoint [4] 0 0
3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
402
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 009 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 013 - Ballarat
Recruitment hospital [3] 0 0
Investigational Site Number 002 - Garran
Recruitment hospital [4] 0 0
Investigational Site Number 007 - Herston
Recruitment hospital [5] 0 0
Investigational Site Number 012 - Hobart
Recruitment hospital [6] 0 0
Investigational Site Number 006 - Liverpool
Recruitment hospital [7] 0 0
Investigational Site Number 010 - Maroubra
Recruitment hospital [8] 0 0
Investigational Site Number 001 - Nedlands
Recruitment hospital [9] 0 0
Investigational Site Number 004 - New Lambton
Recruitment hospital [10] 0 0
Investigational Site Number 008 - Redcliffe
Recruitment hospital [11] 0 0
Investigational Site Number 011 - South Brisbane
Recruitment hospital [12] 0 0
Investigational Site Number 005 - Southport
Recruitment hospital [13] 0 0
Investigational Site Number 003 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
2605 - Garran
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2035 - Maroubra
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
2305 - New Lambton
Recruitment postcode(s) [10] 0 0
4020 - Redcliffe
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Braunau
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Mödling
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Estonia
State/province [7] 0 0
Tallinn
Country [8] 0 0
Finland
State/province [8] 0 0
Hyvinkää
Country [9] 0 0
Finland
State/province [9] 0 0
Pori
Country [10] 0 0
Finland
State/province [10] 0 0
Seinäjoki
Country [11] 0 0
France
State/province [11] 0 0
Avignon Cedex 9
Country [12] 0 0
France
State/province [12] 0 0
BEZIERS Cedex
Country [13] 0 0
France
State/province [13] 0 0
Bron
Country [14] 0 0
France
State/province [14] 0 0
Cholet
Country [15] 0 0
France
State/province [15] 0 0
Lyon Cedex 03
Country [16] 0 0
France
State/province [16] 0 0
NIMES Cedex 9
Country [17] 0 0
France
State/province [17] 0 0
POITIERS Cedex
Country [18] 0 0
France
State/province [18] 0 0
Toulouse Cedex 3
Country [19] 0 0
France
State/province [19] 0 0
Valence Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Vandoeuvre Les Nancy
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Bernau
Country [23] 0 0
Germany
State/province [23] 0 0
Bonn
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt am Main
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Heidenau
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Ludwigsburg
Country [30] 0 0
Germany
State/province [30] 0 0
Paderborn
Country [31] 0 0
Israel
State/province [31] 0 0
Ashkelon
Country [32] 0 0
Israel
State/province [32] 0 0
Beer Yaakov
Country [33] 0 0
Italy
State/province [33] 0 0
Ancona
Country [34] 0 0
Italy
State/province [34] 0 0
Barga
Country [35] 0 0
Italy
State/province [35] 0 0
Catania
Country [36] 0 0
Italy
State/province [36] 0 0
Como
Country [37] 0 0
Italy
State/province [37] 0 0
Cortona
Country [38] 0 0
Italy
State/province [38] 0 0
Mestre
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Italy
State/province [41] 0 0
San Daniele Del Friuli
Country [42] 0 0
Italy
State/province [42] 0 0
Varese
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Suwon
Country [45] 0 0
Mexico
State/province [45] 0 0
Aguascalientes
Country [46] 0 0
Mexico
State/province [46] 0 0
Chihuahua
Country [47] 0 0
Mexico
State/province [47] 0 0
Guadalajara
Country [48] 0 0
Mexico
State/province [48] 0 0
Leon
Country [49] 0 0
Mexico
State/province [49] 0 0
Mexico
Country [50] 0 0
Mexico
State/province [50] 0 0
Monterrey
Country [51] 0 0
Mexico
State/province [51] 0 0
Queretaro
Country [52] 0 0
Mexico
State/province [52] 0 0
Saltillo
Country [53] 0 0
Mexico
State/province [53] 0 0
Tijuana
Country [54] 0 0
Netherlands
State/province [54] 0 0
Amsterdam
Country [55] 0 0
Netherlands
State/province [55] 0 0
Goes
Country [56] 0 0
Netherlands
State/province [56] 0 0
Groningen
Country [57] 0 0
Netherlands
State/province [57] 0 0
Maastricht
Country [58] 0 0
Netherlands
State/province [58] 0 0
Rotterdam
Country [59] 0 0
Portugal
State/province [59] 0 0
Amadora
Country [60] 0 0
Portugal
State/province [60] 0 0
Lisboa
Country [61] 0 0
Spain
State/province [61] 0 0
El Palmar (MURCIA)
Country [62] 0 0
Spain
State/province [62] 0 0
Hospitalet de Llobregat
Country [63] 0 0
Spain
State/province [63] 0 0
La Coruña
Country [64] 0 0
Spain
State/province [64] 0 0
LLeida
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Majadahonda
Country [67] 0 0
Spain
State/province [67] 0 0
Sevilla
Country [68] 0 0
Spain
State/province [68] 0 0
Tarragona
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Switzerland
State/province [70] 0 0
Basel
Country [71] 0 0
Switzerland
State/province [71] 0 0
St.Gallen
Country [72] 0 0
Taiwan
State/province [72] 0 0
Kaohsiung Hsien,
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taichung City
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taichung
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei
Country [77] 0 0
Taiwan
State/province [77] 0 0
Tao Yuan Hsien
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Belfast
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Bournemouth
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Carshalton
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Gloucester
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Wrexham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT01140581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01140581