Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
NCT ID: NCT01140581
Last Updated: 2012-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
402 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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\- 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
DRONEDARONE
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
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
DRONEDARONE
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
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
DRONEDARONE
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
Interventions
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DRONEDARONE
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Investigational Site Number 011
South Brisbane, , Australia
Investigational Site Number 005
Southport, , Australia
Investigational Site Number 003
Woolloongabba, , Australia
Investigational Site Number 040-006
Braunau am Inn, , Austria
Investigational Site Number 040-007
Innsbruck, , Austria
Investigational Site Number 040-002
Linz, , Austria
Investigational Site Number 040-001
Mödling, , Austria
Investigational Site Number 040-005
Vienna, , Austria
Investigational Site Number 040-003
Vienna, , Austria
Investigational Site Number 040-004
Vienna, , Austria
Investigational Site Number 233001
Tallinn, , Estonia
Investigational Site Number 246-001
Hyvinkää, , Finland
Investigational Site Number 246-002
Hyvinkää, , Finland
Investigational Site Number 246-004
Pori, , Finland
Investigational Site Number 246-003
Seinäjoki, , Finland
Investigational Site Number 250-006
Avignon, , France
Investigational Site Number 250-009
Béziers, , France
Investigational Site Number 250-002
Bron, , France
Investigational Site Number 250-007
Cholet, , France
Investigational Site Number 250-008
Lyon, , France
Investigational Site Number 250-010
Nîmes, , France
Investigational Site Number 250-003
Poitiers, , France
Investigational Site Number 250-004
Toulouse, , France
Investigational Site Number 250-005
Valence, , France
Investigational Site Number 250-001
Vandœuvre-lès-Nancy, , France
Investigational Site Number 276-003
Berlin, , Germany
Investigational Site Number 276-006
Bernau, , Germany
Investigational Site Number 276-001
Bonn, , Germany
Investigational Site Number 276-011
Dresden, , Germany
Investigational Site Number 276-010
Frankfurt am Main, , Germany
Investigational Site Number 276-002
Hamburg, , Germany
Investigational Site Number 276-008
Hamburg, , Germany
Investigational Site Number 276-009
Heidenau, , Germany
Investigational Site Number 276-004
Kiel, , Germany
Investigational Site Number 276-005
Ludwigsburg, , Germany
Investigational Site Number 276-007
Paderborn, , Germany
Investigational Site Number 376002
Ashkelon, , Israel
Investigational Site Number 376001
Beer Yaakov, , Israel
Investigational Site Number 380-005
Ancona, , Italy
Investigational Site Number 380-002
Barga, , Italy
Investigational Site Number 380-004
Catania, , Italy
Investigational Site Number 380-001
Como, , Italy
Investigational Site Number 380-006
Cortona, , Italy
Investigational Site Number 380-011
Mestre, , Italy
Investigational Site Number 380-010
Palermo, , Italy
Investigational Site Number 380-007
Roma, , Italy
Investigational Site Number 380-003
Roma, , Italy
Investigational Site Number 380-009
San Daniele del Friuli, , Italy
Investigational Site Number 380-012
Varese, , Italy
Investigational Site Number 484017
Aguascalientes, , Mexico
Investigational Site Number 484012
Chihuahua City, , Mexico
Investigational Site Number 484008
Guadalajara, , Mexico
Investigational Site Number 484009
Guadalajara, , Mexico
Investigational Site Number 484015
Guadalajara, , Mexico
Investigational Site Number 484002
León, , Mexico
Investigational Site Number 484016
México, , Mexico
Investigational Site Number 484004
México, , Mexico
Investigational Site Number 484005
Monterrey, , Mexico
Investigational Site Number 484003
Monterrey, , Mexico
Investigational Site Number 484001
Querétaro, , Mexico
Investigational Site Number 484013
Saltillo, , Mexico
Investigational Site Number 484011
Tijuana, , Mexico
Investigational Site Number 528003
Amsterdam, , Netherlands
Investigational Site Number 528005
Goes, , Netherlands
Investigational Site Number 528002
Groningen, , Netherlands
Investigational Site Number 528001
Maastricht, , Netherlands
Investigational Site Number 528004
Rotterdam, , Netherlands
Investigational Site Number 620005
Amadora, , Portugal
Investigational Site Number 620001
Lisbon, , Portugal
Investigational Site Number 410001
Seoul, , South Korea
Investigational Site Number 410002
Seoul, , South Korea
Investigational Site Number 410003
Seoul, , South Korea
Investigational Site Number 410004
Seoul, , South Korea
Investigational Site Number 410005
Seoul, , South Korea
Investigational Site Number 410006
Suwon, , South Korea
Investigational Site Number 724008
A Coruña, , Spain
Investigational Site Number 724004
El Palmar (murcia), , Spain
Investigational Site Number 724005
L'Hospitalet de Llobregat, , Spain
Investigational Site Number 724003
Lleida, , Spain
Investigational Site Number 724010
Madrid, , Spain
Investigational Site Number 724001
Madrid, , Spain
Investigational Site Number 724002
Majadahonda, , Spain
Investigational Site Number 724006
Seville, , Spain
Investigational Site Number 724007
Tarragona, , Spain
Investigational Site Number 724009
Valencia, , Spain
Investigational Site Number 756001
Basel, , Switzerland
Investigational Site Number 756002
Sankt Gallen, , Switzerland
Investigational Site Number 158006
Kaohsiung City, , Taiwan
Investigational Site Number 158005
Kaohsiung Hsien,, , Taiwan
Investigational Site Number 158004
Taichung, , Taiwan
Investigational Site Number 158003
Taichung, , Taiwan
Investigational Site Number 158009
Taichung, , Taiwan
Investigational Site Number 158002
Taipei, , Taiwan
Investigational Site Number 158001
Taipei, , Taiwan
Investigational Site Number 158008
Taipei, , Taiwan
Investigational Site Number 158007
Tao Yuan Hsien, , Taiwan
Investigational Site Number 826006
Belfast, , United Kingdom
Investigational Site Number 826-005
Bournemouth, , United Kingdom
Investigational Site Number 826-001
Carshalton, , United Kingdom
Investigational Site Number 826-002
Gloucester, , United Kingdom
Investigational Site Number 826-007
Wrexham, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2009-016818-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRONE_C_03668
Identifier Type: -
Identifier Source: org_study_id
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