atrial fibrillation/atrial flutter MedDRA version: 7.1 Level: LLT Classification code 10003658
Conditions
Interventions
Product Name: dronedarone
Product Code: SR33589B
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dronedarone
CAS Number: 14
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients aged 75 years or older are eligible with or without additional risk factors Or A minimum age of 70 years with one or more of the following risk factors must be present at the baseline : hypertension (taking antihypertensive drugs of at least two different classes), diabetes, prior cerebrovascular accident or systemic embolism, left atrium diameter greater than or equal to 50 mm by M-mode echocardiography, left ventricular ejection fraction less than 0.4 by 2D echocardiography. -Availibility of one 12-lead ECG within the last 6 months, showing that the patient was or is in AF/AFL, -Availibility of one 12-lead ECG within the last 6 months showing that the patient was or is in sinus rhythm. 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: -Any non cardiovascular illness or disorder that could preclude participation or severely limit survival. -Pregnant women, women of child-bearing potential without adequat birth control, breast feeding women. - Patients in permanent atrial fibrillation - Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with IV pressor agents; patients on respirator; congestive heart failure of stage NYHA IV 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 - Planned major non-cardiac or cardiac surgery or procedures - Acute myocarditis or constrictive pericarditis - Bradycardia < 50 bpm and/or PR-interval ³ 0.28 sec on the last 12-lead ECG. - Significant sinus node disease or 2nd or 3rd degree atrioventricular block unless treated with a pacemaker - Need of a concomitant medication that is prohibited in this trial - Plasma potassium < 3.5 mmol/l - A calculated GFR at baseline <10 ml/min (using the Cockroft Gault formula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of dronedarone in preventing cardiovascular hospitalizations or death from any cause in a population of high risk patients with Atrial Fibrillation/Atrial FLutter (AF/AFL).;Secondary Objective: To assess that dronedarone is well tolerated in this population;Primary end point(s): first occurence of hospitalization for cardiovascular reasons or death from any cause. | — |
Countries
Belgium, Czech Republic, Finland, Germany, Hungary, Italy, Norway, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed