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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
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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


  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


  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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