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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2023

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At a glance

  • Drugs Dronedarone (Primary)
  • Indications Atrial fibrillation; Atrial flutter
  • Focus Registrational; Therapeutic Use
  • Acronyms ATHENA
  • Sponsors Sanofi

    • Most Recent Events

    • 30 Mar 2023 Results of post hoc analysis assessing the effect of dronedarone on the estimated burden of atrial fibrillation / atrial flutter progression to presumed permanent AF/AFL, and regression to sinus rhythm, compared with placebo, published in the Europace.
    • 22 Nov 2022 Results post hoc analysis assessing Efficacy and safety of dronedarone across age and sex subgroups among patients with non-permanent atrial fibrillation published in the Europace
    • 29 Aug 2022 Results of post hoc analysis of ATHENA assessing the effect of dronedarone on estimated AF/AFL burden, and AF progression to presumed permanent AF/AFL or AF regression to sinus rhythm presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology
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