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

sanofi-aventis recherche & développement0 个研究点目标入组 4,300 人开始时间: 2005年4月19日最近更新: 2019年11月25日

适应症

试验速览

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•-Patients aged 75 years or older are eligible with or without additional risk factors
•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

•-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)

发起方