Atrial Fibrillation MedDRA version: 14.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion 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 - Patient and physician decision to allow AF to continue without further efforts to restore sinus rhythm Patients aged 65 years or older with 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 less or equal to 0.40 - Peripheral arterial occlusive disease - Aged 75 years or older with both hypertension and diabetes mellitus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Demonstrate the efficacy of dronedarone in preventing cardiovascular death;Primary end point(s): • Composite endpoint of first stroke, systemic arterial embolism, myocardial infarction or cardiovascular death • Composite endpoint of first unplanned cardiovascular hospitalization or death from any cause;Main 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 | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed