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


Phase 3 Results

Summary of Purpose

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.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 5 January 2010.

1 Jun 2005 13 Sep 2005 1 Mar 2008 1 Mar 2008 1 Jan 2010 24 Jul 2009
Start Date First Received 1st Completion Completion Verification Results

Trial Basics




Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment


  • Department of Cardiology, J.W. Goethe University, Frankfurt, Germany. hohnloser@em.uni-frankfurt.de