Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors

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).

The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

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.