A placebo-controlled, double blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter (AF/AFL) - ATHENA

• Conditions: atrial fibrillation/atrial flutter; MedDRA version: 7.1Level: LLTClassification code 10003658

• Registration Number: EUCTR2005-000715-98-FI
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-03
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4300

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 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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.