Atrial Fibrillation Clinical Trial
— ARTEMIS LoadOfficial 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)
Status | Completed |
Enrollment | 402 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | 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 | |
Austria | Investigational Site Number 040-006 | Braunau | |
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 040-003 | Vienna | |
Austria | Investigational Site Number 040-004 | Wien | |
Austria | Investigational Site Number 040-005 | Wien | |
Estonia | Investigational Site Number 233001 | Tallinn | |
Finland | 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 | |
France | Investigational Site Number 250-006 | Avignon Cedex 9 | |
France | Investigational Site Number 250-009 | BEZIERS Cedex | |
France | Investigational Site Number 250-002 | Bron | |
France | Investigational Site Number 250-007 | Cholet | |
France | Investigational Site Number 250-008 | Lyon Cedex 03 | |
France | Investigational Site Number 250-010 | NIMES Cedex 9 | |
France | Investigational Site Number 250-003 | POITIERS Cedex | |
France | Investigational Site Number 250-004 | Toulouse Cedex 3 | |
France | Investigational Site Number 250-005 | Valence Cedex 9 | |
France | Investigational Site Number 250-001 | Vandoeuvre Les Nancy | |
Germany | 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 | |
Israel | Investigational Site Number 376002 | Ashkelon | |
Israel | Investigational Site Number 376001 | Beer Yaakov | |
Italy | 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 380-003 | Roma | |
Italy | Investigational Site Number 380-007 | Roma | |
Italy | Investigational Site Number 380-009 | San Daniele Del Friuli | |
Italy | Investigational Site Number 380-012 | Varese | |
Korea, Republic of | Investigational Site Number 410001 | Seoul | |
Korea, Republic of | Investigational Site Number 410002 | Seoul | |
Korea, Republic of | Investigational Site Number 410003 | Seoul | |
Korea, Republic of | Investigational Site Number 410004 | Seoul | |
Korea, Republic of | Investigational Site Number 410005 | Seoul | |
Korea, Republic of | Investigational Site Number 410006 | Suwon | |
Mexico | Investigational Site Number 484017 | Aguascalientes | |
Mexico | Investigational Site Number 484012 | Chihuahua | |
Mexico | Investigational Site Number 484008 | Guadalajara | |
Mexico | Investigational Site Number 484009 | Guadalajara | |
Mexico | Investigational Site Number 484015 | Guadalajara | |
Mexico | Investigational Site Number 484002 | Leon | |
Mexico | Investigational Site Number 484004 | Mexico | |
Mexico | Investigational Site Number 484016 | Mexico | |
Mexico | Investigational Site Number 484003 | Monterrey | |
Mexico | Investigational Site Number 484005 | Monterrey | |
Mexico | Investigational Site Number 484001 | Queretaro | |
Mexico | Investigational Site Number 484013 | Saltillo | |
Mexico | Investigational Site Number 484011 | Tijuana | |
Netherlands | 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 | |
Portugal | Investigational Site Number 620005 | Amadora | |
Portugal | Investigational Site Number 620001 | Lisboa | |
Spain | Investigational Site Number 724004 | El Palmar (MURCIA) | |
Spain | Investigational Site Number 724005 | Hospitalet de Llobregat | |
Spain | Investigational Site Number 724008 | La Coruña | |
Spain | Investigational Site Number 724003 | LLeida | |
Spain | Investigational Site Number 724001 | Madrid | |
Spain | Investigational Site Number 724010 | Madrid | |
Spain | Investigational Site Number 724002 | Majadahonda | |
Spain | Investigational Site Number 724006 | Sevilla | |
Spain | Investigational Site Number 724007 | Tarragona | |
Spain | Investigational Site Number 724009 | Valencia | |
Switzerland | Investigational Site Number 756001 | Basel | |
Switzerland | Investigational Site Number 756002 | St.Gallen | |
Taiwan | Investigational Site Number 158006 | Kaohsiung | |
Taiwan | Investigational Site Number 158005 | Kaohsiung Hsien, | |
Taiwan | Investigational Site Number 158003 | Taichung | |
Taiwan | Investigational Site Number 158004 | Taichung | |
Taiwan | Investigational Site Number 158009 | Taichung City | |
Taiwan | Investigational Site Number 158001 | Taipei | |
Taiwan | Investigational Site Number 158002 | Taipei | |
Taiwan | Investigational Site Number 158008 | Taipei | |
Taiwan | Investigational Site Number 158007 | Tao Yuan Hsien | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Australia, Austria, Estonia, Finland, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Spain, Switzerland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AF recurrences | two consecutives 12-lead ECG or Trans-Telephonic ECG monitoring (TTEM) approximatively 10 minutes apart and both showing AF | one month after randomization | No |
Secondary | AF recurrences | two months after randomization | No | |
Secondary | Symptomatic bradycardia | Heart rate at rest < 50 beats per minute | two months after randomization | No |
Secondary | Tachycardia | Heart rate at rest > 120 beats per minute | two months after randomization | No |
Secondary | Dronedarone and amiodarone concentrations in plasma | Limited to a subset of countries | 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake | No |
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