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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-19
• Study Completion: 2008-03-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

-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.