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

Completed

Phase 3 Results

Trial Description

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.

Detailed Description

This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: oral administration (tablets)
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: matching placebo tablets
  • Dronedarone (Multaq)Drug
    Intervention Desc: Mainly for the indication of cardiac arrhythmias (irregular heartbeat).
  • Dronedarone (SR33589) Drug
    Other Names: Multaq®
    Intervention Desc: oral administration (tablets)
    ARM 1: Kind: Experimental
    Label: Dronedarone 400mg bid
    Description: Dronedarone 400mg tablets twice daily (bid)

Trial Design

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

Patient Involvement

After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study wil be monitored by an independent DMC for safety, tolerability and efficacy.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy variable will be the time from randomization to death from any cause or hospitalization for cardiovascular reason, whichever is earlier.
Secondary Secondary criteria are: Death from any cause, Cardiovascular death, Hospitalization for cardiovascular reasons
Primary First Hospitalization for Cardiovascular Reason or Death From Any Cause minimum follow-up duration: 1 year ; maximum: 2.5 years No
Secondary Death From Any Cause minimum follow-up duration: 1 year ; maximum: 2.5 years No
Secondary First Hospitalization for Cardiovascular Reason minimum follow-up duration: 1 year ; maximum: 2.5 years No
Secondary Cardiovascular Death minimum follow-up duration: 1 year ; maximum: 2.5 years No

Sponsors