Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Dronedarone; Placebo (for Dronedarone)
Intervention description: Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner); film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)
Intervention MeSH terms: Dronedarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3236.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events
           (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or
           unplanned cardiovascular hospitalization or death from any cause in patients with
           permanent Atrial Fibrillation [AF] and additional risk factors

      Secondary Objective:

        -  Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

      This was an event-driven study where a common study end date [CSED] was to be determined by
      Steering Committee based on the number of events (stroke, systemic arterial embolism,
      myocardial infarction or cardiovascular death).
    

Eligibility criteria:

        Inclusion criteria:

          -  Permanent AF defined by the presence of all of the following criteria:

               -  Availability of one 12-lead ECG not more than 14 days prior to randomization
                  showing that the patient is in AF or atrial flutter;

               -  Availability of documentation (including either rhythm strips or medical report
                  of the rhythm) showing that the patient was in AF or atrial flutter at least 6
                  months prior to randomization;

               -  No evidence of sinus rhythm in the period between these two documentations of AF;

               -  Decision of the patient and physician to allow AF to continue without further
                  efforts to restore sinus rhythm.

          -  At least one of the following risk criteria:

               -  Coronary artery disease;

               -  Prior stroke or Transient Ischemic Attack [TIA];

               -  Symptomatic heart failure;

               -  Left ventricular ejection fraction [LVEF] less or equal to 0.40;

               -  Peripheral arterial occlusive disease;

               -  Aged 75 years or older with both hypertension and diabetes mellitus.

        Exclusion criteria:

          -  Paroxysmal AF;

          -  Persistent AF without a decision to allow AF to continue without further efforts to
             restore sinus rhythm;

          -  Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA
             class III.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.