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A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation (ATHENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174785
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : December 23, 2009
Last Update Posted : January 12, 2010
Information provided by:

Brief Summary:

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).

To assess that dronedarone is well tolerated in this population.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Drug: dronedarone (SR33589) Drug: placebo Phase 3

Detailed Description:
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)
Study Start Date : June 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone

Arm Intervention/treatment
Experimental: Dronedarone 400mg bid
Dronedarone 400mg tablets twice daily (bid)
Drug: dronedarone (SR33589)
oral administration (tablets)
Other Name: Multaq®

Placebo Comparator: Placebo
matching placebo tablets
Drug: placebo
oral administration (tablets)

Primary Outcome Measures :
  1. First Hospitalization for Cardiovascular Reason or Death From Any Cause [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

Secondary Outcome Measures :
  1. Death From Any Cause [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]
  2. First Hospitalization for Cardiovascular Reason [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]
  3. Cardiovascular Death [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:

    • 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:

General 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174785

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
New South Wales, Australia
Sanofi-Aventis Administrative Office
Wien, 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
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Athens, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Natanya, Israel
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Sanofi-Aventis Administrative Office
Gouda, Netherlands
New Zealand
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Macquarie Park, New Zealand
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Makati City, Philippines
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Russian Federation
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Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
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
Megrine, Tunisia
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: International Clinical Development Sanofi
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: International Clinical Development - Study Director, sanofi-aventis Identifier: NCT00174785    
Other Study ID Numbers: EFC5555
First Posted: September 15, 2005    Key Record Dates
Results First Posted: December 23, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010
Keywords provided by Sanofi:
Mortality, Hospitalization
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents