Resumen

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.

Descripción detallada

This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

Elegibilidad

Edad mínima: 70 YearsSexo: ALL

Criterios de inclusión

\. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:
Hypertension (taking antihypertensive drugs of at least two different classes)
Diabetes
Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism
Left atrium diameter greater than or equal to 50 mm by echocardiography
Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography)
\. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
\. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm

Criterios de exclusión

General criteria:
\. Refusal or inability to give informed consent to participate in the study
\. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
\. 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.
\. Breastfeeding women
\. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
\. Previous participation in this trial
Criteria Related to a cardiac condition:
\. 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 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
\. 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
\. Acute myocarditis or constrictive pericarditis
\. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
\. 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:
\. 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:
\. Plasma potassium \< 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
\. A calculated Glomerular Filtration Rate (GFR) at baseline \<10 ml/min using the Cockroft Gault formula

A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

dronedarone (SR33589)

placebo

Ubicaciones

Sanofi-Aventis Administrative Office

Patrocinadores