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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT01151137

Run by

Sanofi

People needed

3236

Starts

2010-07-01

Expected to finish

2011-09-01

Last updated by the study team

2012-10-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Providencia Santiago, Chile
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Frankfurt, Germany
• Sanofi-Aventis Administrative Office — Kallithea, Greece
• Sanofi-Aventis Administrative Office — Hong Kong, Hong Kong
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — Col. Coyoacan, Mexico
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Auckland, New Zealand
• Sanofi-Aventis Administrative Office — Lysaker, Norway
• Sanofi-Aventis Administrative Office — Warsaw, Poland

Full record on ClinicalTrials.gov

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