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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174785
First received: September 13, 2005
Last updated: January 5, 2010
Last verified: January 2010
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Atrial Flutter
Interventions: Drug: dronedarone (SR33589)
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of patients started on June 29, 2005 and was completed on December 30, 2006. The study was conducted at 551 centers in 37 countries. The common study end date ensuring a minimum planned follow-up of one year was December 30th, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets

Participant Flow:   Overall Study
    Dronedarone 400mg Bid     Placebo  
STARTED     2301 [1]   2327 [2]
COMPLETED     1605 [3]   1611 [3]
NOT COMPLETED     696     716  
Adverse Event                 293                 191  
Protocol Violation                 14                 14  
Withdrawal by Subject                 173                 175  
Atrial Fibrillation/Flutter recurrence                 110                 167  
Prohibited antiarrhythmic medication                 39                 88  
Other prohibited medication                 5                 3  
Family request                 6                 8  
Not pre-specified/Not coded                 56                 70  
[1] randomized patients; among them, 10 patients did not receive any study drug in the dronedarone group
[2] randomized patients; among them, 14 patients did not receive any study drug in the placebo group
[3] completed study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets
Total Total of all reporting groups

Baseline Measures
    Dronedarone 400mg Bid     Placebo     Total  
Number of Participants  
[units: participants]
  2301     2327     4628  
Age, Customized  
[units: participants]
     
18 to < 65 years     431     442     873  
65 to < 75 years     923     907     1830  
>= 75 years     947     978     1925  
Age  
[units: years]
Mean ± Standard Deviation
  71.6  ± 8.9     71.7  ± 9.0     71.6  ± 9.0  
Gender  
[units: participants]
     
Female     1131     1038     2169  
Male     1170     1289     2459  



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

2.  Secondary:   Death From Any Cause   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

3.  Secondary:   First Hospitalization for Cardiovascular Reason   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

4.  Secondary:   Cardiovascular Death   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]

5.  Other Pre-specified:   Adjudicated Cardiovascular Death   [ Time Frame: minimum follow-up duration: 1 year ; maximum: 2.5 years ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Additional Description Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Dronedarone 400mg Bid dronedarone tablets 400mg twice daily
Placebo matching placebo tablets

Other Adverse Events
    Dronedarone 400mg Bid     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     1584/2291     1527/2313  
Cardiac disorders      
Any cardiac disorders * 1    
# participants affected / at risk     251/2291 (10.96%)     213/2313 (9.21%)  
Gastrointestinal disorders      
Any Gastrointestinal disorders * 1    
# participants affected / at risk     573/2291 (25.01%)     478/2313 (20.67%)  
Diarrhoea * 1    
# participants affected / at risk     222/2291 (9.69%)     142/2313 (6.14%)  
Nausea * 1    
# participants affected / at risk     122/2291 (5.33%)     71/2313 (3.07%)  
General disorders      
Any general disorders and administration site conditions * 1    
# participants affected / at risk     397/2291 (17.33%)     348/2313 (15.05%)  
Oedema peripheral * 1    
# participants affected / at risk     147/2291 (6.42%)     119/2313 (5.14%)  
Fatigue * 1    
# participants affected / at risk     115/2291 (5.02%)     90/2313 (3.89%)  
Infections and infestations      
Any infections and infestations * 1    
# participants affected / at risk     508/2291 (22.17%)     533/2313 (23.04%)  
Injury, poisoning and procedural complications      
Any injury, poisoning and procedural complications * 1    
# participants affected / at risk     187/2291 (8.16%)     198/2313 (8.56%)  
Investigations      
Any investigation disorders * 1    
# participants affected / at risk     298/2291 (13.01%)     199/2313 (8.60%)  
Metabolism and nutrition disorders      
Any metabolism and nutrition disorders * 1    
# participants affected / at risk     171/2291 (7.46%)     183/2313 (7.91%)  
Musculoskeletal and connective tissue disorders      
Any musculoskeletal and connective tissue disorders * 1    
# participants affected / at risk     364/2291 (15.89%)     376/2313 (16.26%)  
Nervous system disorders      
Any nervous system disorders * 1    
# participants affected / at risk     362/2291 (15.80%)     365/2313 (15.78%)  
Dizziness * 1    
# participants affected / at risk     160/2291 (6.98%)     145/2313 (6.27%)  
Psychiatric disorders      
Any psychiatric disorders * 1    
# participants affected / at risk     106/2291 (4.63%)     125/2313 (5.40%)  
Respiratory, thoracic and mediastinal disorders      
Any respiratory, thoracic and mediastinal disorders * 1    
# participants affected / at risk     315/2291 (13.75%)     318/2313 (13.75%)  
Dyspnoea * 1    
# participants affected / at risk     120/2291 (5.24%)     96/2313 (4.15%)  
Skin and subcutaneous tissue disorders      
Any skin and subcutaneous tissue disorders * 1    
# participants affected / at risk     235/2291 (10.26%)     174/2313 (7.52%)  
Vascular disorders      
Any vascular disorders * 1    
# participants affected / at risk     179/2291 (7.81%)     187/2313 (8.08%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (10.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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