Health Condition 1: null- Permanent Atrial fibriLLAtion Health Condition 2: I489- Unspecified atrial fibrillation and atrial flutter
Conditions
Interventions
Intervention1: Dronedarone-Oral: 400 mg- (twise a day ) for 2 years 3 months
Control Intervention1: Placebo: Placebo
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in permanent atrial fibrillation with additional risk factors 2. Patients in permanent atrial fibrillation defined by the presence of all of the following criteria: 1. Availability of one 12-lead ECG not more than 14 days prior to randomization, showing that the patient is in atrial fibrillation or atrial flutter 2. Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in atrial fibrillation or atrial flutter at least 6 months prior to randomization 3. No evidence of sinus rhythm in the period between these two documentations of atrial fibrillation 4. Patient and physician decision to allow atrial fibrillation to continue without further efforts to restore sinus rhythm 5.Patients aged 65 years or older with at least one of the following risk factors or combination of risk factors: 1.Coronary artery disease 2. Prior stroke or TIA 3. Symptomatic heart failure 4. Left ventricular ejection fraction less than or equal to 0.40 5. Peripheral arterial occlusive disease 6. Aged 75 years or older with both hypertension and diabetes mellitus"
Exclusion criteria
Exclusion criteria: "Exclusion Criteria (selection) E 01. Patients in paroxysmal atrial fibrillation E 02. Patients in persistent atrial fibrillation without a decision to allow atrial fibrillation to continue without further efforts to restore sinus rhythm E 11. Patients with heart failure of NYHA class IV or recent unstable NYHA class III"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Composite endpoint of first stroke, systemic arterial embolism, myocardial infarction or cardiovascular death 2.Composite endpoint of first unplanned cardiovascular hospitalization or death from any causeTimepoint: 1.The Common Study End Date will be anticipated based on the projected blind number of events to reach 844 coprimary events not refuted by adjudication (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) but cannot be less than 3 months after the last patient randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Kazakhstan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSalini James
Outcome results
None listed