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

Exclusion Criteria

• •General criteria:
• •1\. Refusal or inability to give informed consent to participate in the study
• •2\. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
• •3\. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intra-uterine device (IUD)\] or sterile can be randomized.
• •4\. Breastfeeding women
• •5\. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
• •6\. Previous participation in this trial
• •Criteria Related to a cardiac condition:
• •7\. Patients in permanent atrial fibrillation
• •8\. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization
• •9\. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list
• •10\. Acute myocarditis or constrictive pericarditis
• •11\. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
• •12\. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker
• •Criteria Related to Concomitant Medications:
• •13\. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period
• •Criteria Related to Laboratory Abnormalities:
• •14\. Plasma potassium \< 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
• •15\. A calculated Glomerular Filtration Rate (GFR) at baseline \<10 ml/min using the Cockroft Gault formula