A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
NCT ID: NCT00174785
Last Updated: 2010-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4628 participants
INTERVENTIONAL
2005-06-30
2008-03-31
Brief Summary
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To assess that dronedarone is well tolerated in this population.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dronedarone 400mg bid
Dronedarone 400mg tablets twice daily (bid)
dronedarone (SR33589)
oral administration (tablets)
Placebo
matching placebo tablets
placebo
oral administration (tablets)
Interventions
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dronedarone (SR33589)
oral administration (tablets)
placebo
oral administration (tablets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypertension (taking antihypertensive drugs of at least two different classes)
* Diabetes
* Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism
* Left atrium diameter greater than or equal to 50 mm by echocardiography
* Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography)
* 2\. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
* 3\. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm
Exclusion Criteria
* 1\. Refusal or inability to give informed consent to participate in the study
* 2\. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
* 3\. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intra-uterine device (IUD)\] or sterile can be randomized.
* 4\. Breastfeeding women
* 5\. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
* 6\. Previous participation in this trial
Criteria Related to a cardiac condition:
* 7\. Patients in permanent atrial fibrillation
* 8\. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization
* 9\. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list
* 10\. Acute myocarditis or constrictive pericarditis
* 11\. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
* 12\. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker
Criteria Related to Concomitant Medications:
* 13\. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period
Criteria Related to Laboratory Abnormalities:
* 14\. Plasma potassium \< 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
* 15\. A calculated Glomerular Filtration Rate (GFR) at baseline \<10 ml/min using the Cockroft Gault formula
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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International Clinical Development
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
New South Wales, , Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Shangaï, , China
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Causeway Bay, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Casablanca, , Morocco
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Macquarie Park, , New Zealand
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Makati City, , Philippines
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Bangkok, , Thailand
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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References
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Hohnloser SH, Connolly SJ, Crijns HJ, Page RL, Seiz W, Torp-Petersen C. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol. 2008 Jan;19(1):69-73. doi: 10.1111/j.1540-8167.2007.01016.x. Epub 2007 Nov 21.
Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009 Feb 12;360(7):668-78. doi: 10.1056/NEJMoa0803778.
Kirchhof P, Camm AJ, Crijns HJGM, Piccini JP, Torp-Pedersen C, McKindley DS, Wieloch M, Hohnloser SH. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. 2025 Mar 28;27(4):euaf080. doi: 10.1093/europace/euaf080.
Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.
Vamos M, Oldgren J, Nam GB, Lip GYH, Calkins H, Zhu J, Ueng KC, Ludwigs U, Wieloch M, Stewart J, Hohnloser SH. Dronedarone vs. placebo in patients with atrial fibrillation or atrial flutter across a range of renal function: a post hoc analysis of the ATHENA trial. Eur Heart J Cardiovasc Pharmacother. 2022 Jun 8;8(4):363-371. doi: 10.1093/ehjcvp/pvab090.
Akerborg O, Nilsson J, Bascle S, Lindgren P, Reynolds M. Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, Sweden, and Switzerland. Clin Ther. 2012 Aug;34(8):1788-802. doi: 10.1016/j.clinthera.2012.06.007. Epub 2012 Jul 6.
Torp-Pedersen C, Crijns HJ, Gaudin C, Page RL, Connolly SJ, Hohnloser SH; ATHENA Investigators. Impact of dronedarone on hospitalization burden in patients with atrial fibrillation: results from the ATHENA study. Europace. 2011 Aug;13(8):1118-26. doi: 10.1093/europace/eur102. Epub 2011 May 15.
Page RL, Connolly SJ, Crijns HJ, van Eickels M, Gaudin C, Torp-Pedersen C, Hohnloser SH; ATHENA Investigators. Rhythm- and rate-controlling effects of dronedarone in patients with atrial fibrillation (from the ATHENA trial). Am J Cardiol. 2011 Apr 1;107(7):1019-22. doi: 10.1016/j.amjcard.2010.11.028. Epub 2011 Feb 4.
Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C, Connolly SJ; ATHENA Investigators. Dronedarone in patients with congestive heart failure: insights from ATHENA. Eur Heart J. 2010 Jul;31(14):1717-21. doi: 10.1093/eurheartj/ehq113. Epub 2010 Apr 30.
Related Links
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Related Info
Other Identifiers
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EFC5555
Identifier Type: -
Identifier Source: org_study_id
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