Atrial FibrillationPhase 4ARTEMIS LoadNCT01140581
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
A Phase 4 study testing DRONEDARONE in people with Atrial Fibrillation, run by Sanofi at 111 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DRONEDARONE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 111 sitesin 16 countries
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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)
Who cannot join
- Screening:
- Contraindication to oral anticoagulation
- Acute condition known to cause AF
- Permanent AF
- Paroxysmal AF
- Bradycardia < 50 bpm on the 12-lead ECG
Show all 35Show fewer
- 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.
Trial locations and contacts
111 sites in 16 countries.
111 sites in 16 countries
Australia13 sites
Investigational Site Number 009
Adelaide, 5000
Investigational Site Number 013
Ballarat, 3350
Investigational Site Number 002
Garran, 2605
Investigational Site Number 007
Herston, 4006
Investigational Site Number 012
Hobart, 7000
Investigational Site Number 006
Liverpool, 2170
Investigational Site Number 010
Maroubra, 2035
Investigational Site Number 001
Nedlands, 6009
Investigational Site Number 004
New Lambton, 2305
Investigational Site Number 008
Redcliffe, 4020
Investigational Site Number 011
South Brisbane, 4101
Investigational Site Number 005
Southport, 4215
Investigational Site Number 003
Woolloongabba, 4102
Mexico13 sites
Investigational Site Number 484017
Aguascalientes, 20230
Investigational Site Number 484012
Chihuahua City, 31238
Investigational Site Number 484008
Guadalajara, 44200
Investigational Site Number 484009
Guadalajara, 44600
Investigational Site Number 484015
Guadalajara, 44600
Investigational Site Number 484002
León, 37150
Investigational Site Number 484016
México, 06140
Investigational Site Number 484004
México, 07760
Investigational Site Number 484005
Monterrey, 64460
Investigational Site Number 484003
Monterrey, 64710
Investigational Site Number 484001
Querétaro, 76000
Investigational Site Number 484013
Saltillo, 25230
Investigational Site Number 484011
Tijuana, 22450
Germany11 sites
Investigational Site Number 276-003
Berlin, 13055
Investigational Site Number 276-006
Bernau, 16321
Investigational Site Number 276-001
Bonn, 53115
Investigational Site Number 276-011
Dresden, 01099
Investigational Site Number 276-010
Frankfurt am Main, 60594
Investigational Site Number 276-002
Hamburg, 22041
Investigational Site Number 276-008
Hamburg, 22527
Investigational Site Number 276-009
Heidenau, 01809
Investigational Site Number 276-004
Kiel, 24105
Investigational Site Number 276-005
Ludwigsburg, 71634
Investigational Site Number 276-007
Paderborn, 33098
Italy11 sites
Investigational Site Number 380-005
Ancona, 60100
Investigational Site Number 380-002
Barga, 55051
Investigational Site Number 380-004
Catania, 95124
Investigational Site Number 380-001
Como, 22100
Investigational Site Number 380-006
Cortona, 52042
Investigational Site Number 380-011
Mestre, 30174
Investigational Site Number 380-010
Palermo, 90127
Investigational Site Number 380-007
Roma, 00168
Investigational Site Number 380-003
Roma, 00169
Investigational Site Number 380-009
San Daniele del Friuli, 33038
Investigational Site Number 380-012
Varese, 21100
France10 sites
Investigational Site Number 250-006
Avignon, 84902
Investigational Site Number 250-009
Béziers, 34525
Investigational Site Number 250-002
Bron, 69677
Investigational Site Number 250-007
Cholet, 49300
Investigational Site Number 250-008
Lyon, 69275
Investigational Site Number 250-010
Nîmes, 30029
Investigational Site Number 250-003
Poitiers, 86021
Investigational Site Number 250-004
Toulouse, 31076
Investigational Site Number 250-005
Valence, 26953
Investigational Site Number 250-001
Vandœuvre-lès-Nancy, 54511
Spain10 sites
Investigational Site Number 724008
A Coruña, 15006
Investigational Site Number 724004
El Palmar (murcia), 30120
Investigational Site Number 724005
L'Hospitalet de Llobregat, 08907
Investigational Site Number 724003
Lleida
Investigational Site Number 724010
Madrid, 28034
Investigational Site Number 724001
Madrid, 28040
Investigational Site Number 724002
Majadahonda, 28222
Investigational Site Number 724006
Seville, 41071
Investigational Site Number 724007
Tarragona, 43007
Investigational Site Number 724009
Valencia, 46014
Taiwan9 sites
Investigational Site Number 158006
Kaohsiung City, 807
Investigational Site Number 158005
Kaohsiung Hsien,
Investigational Site Number 158004
Taichung, 402
Investigational Site Number 158003
Taichung, 407
Investigational Site Number 158009
Taichung
Investigational Site Number 158002
Taipei, 100
Investigational Site Number 158001
Taipei
Investigational Site Number 158008
Taipei
Investigational Site Number 158007
Tao Yuan Hsien
Austria7 sites
Investigational Site Number 040-006
Braunau am Inn, 5280
Investigational Site Number 040-007
Innsbruck, 6020
Investigational Site Number 040-002
Linz, 4010
Investigational Site Number 040-001
Mödling, 2340
Investigational Site Number 040-005
Vienna, 1090
Investigational Site Number 040-003
Vienna
Investigational Site Number 040-004
Vienna
South Korea6 sites
Investigational Site Number 410001
Seoul, 152-703
Investigational Site Number 410002
Seoul
Investigational Site Number 410003
Seoul
Investigational Site Number 410004
Seoul
Investigational Site Number 410005
Seoul
Investigational Site Number 410006
Suwon, 443-721
Netherlands5 sites
Investigational Site Number 528003
Amsterdam
Investigational Site Number 528005
Goes
Investigational Site Number 528002
Groningen
Investigational Site Number 528001
Maastricht
Investigational Site Number 528004
Rotterdam
United Kingdom5 sites
Investigational Site Number 826006
Belfast, BT126BA
Investigational Site Number 826-005
Bournemouth, BH77DW
Investigational Site Number 826-001
Carshalton, SM51AA
Investigational Site Number 826-002
Gloucester, GL13NN
Investigational Site Number 826-007
Wrexham, LL137TD
Finland4 sites
Investigational Site Number 246-001
Hyvinkää, 05850
Investigational Site Number 246-002
Hyvinkää, 05850
Investigational Site Number 246-004
Pori, 28210
Investigational Site Number 246-003
Seinäjoki, 60220
Israel2 sites
Investigational Site Number 376002
Ashkelon
Investigational Site Number 376001
Beer Yaakov
Portugal2 sites
Investigational Site Number 620005
Amadora, 2720-276
Investigational Site Number 620001
Lisbon, 1169-024
Switzerland2 sites
Investigational Site Number 756001
Basel, 4031
Investigational Site Number 756002
Sankt Gallen, 9007
About this study
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.
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)
- Conditions
- Atrial Fibrillation
- Being tested
- DRONEDARONE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRONEDARONEDrug
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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 Receives: Drug: DRONEDARONE |
| Group B | Experimental | 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 Receives: Drug: DRONEDARONE |
| Group C | Experimental | 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 Receives: Drug: DRONEDARONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrences
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
Measured: one month after randomization
Secondary outcomes (4)
AF recurrences
Measured: two months after randomization
Symptomatic bradycardia
Heart rate at rest < 50 beats per minute
Measured: two months after randomization
Tachycardia
Heart rate at rest > 120 beats per minute
Measured: two months after randomization
Dronedarone and amiodarone concentrations in plasma
Limited to a subset of countries
Measured: 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140581
- Sponsor's protocol ID
- DRONE_C_03668
- Other IDs
- 2009-016818-24, 2009
- Acronym
- ARTEMIS Load
- Status last verified
- Jan 2012
- First submitted
- 8 Jun 2010
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32500725
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01140581
- Acronym / sponsor ID
- ARTEMIS Load / DRONE_C_03668
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: DRONEDARONEAmiodarone 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 | Experimental | Drug: DRONEDARONEAmiodarone 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 | Experimental | Drug: DRONEDARONEAmiodarone 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Outpatient and Inpatients (except patients hospitalized during screening period for SAE)
Key exclusion criteria (35 listed)
- Contraindication to oral anticoagulation
- Acute condition known to cause AF
- Permanent AF
- Paroxysmal AF
- Bradycardia < 50 bpm on the 12-lead ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRONEDARONEPharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg | Drug | Group A, Group B, Group C |
Primary outcome
AF recurrences
Time frame: one month after randomization
two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF
4 secondary outcomes
AF recurrences
Time frame: two months after randomization
Symptomatic bradycardia
Time frame: two months after randomization
Tachycardia
Time frame: two months after randomization
Dronedarone and amiodarone concentrations in plasma
Time frame: 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
- Derived from this study: PubMed 32500725Naccarelli 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
111 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DRONEDARONE in people with Atrial Fibrillation, run by Sanofi at 111 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in Australia, Mexico, Germany, Italy, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrences (time frame: one month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.