EUCTR2006-005804-15-FI进行中（未招募）不适用
Randomized double blind trial to evaluate the efficacy and safety of dronedarone (400 mg BID) versus amiodarone (600 mg daily for 28 days then 200 mg daily thereafter) for at least 6 months for the maintenance of sinus rhythm in patients with atrial fibrillation (AF) - DIONYSOS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 472
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with documented AF for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the Investigator and receiving anticoagulants,
- •- Signed informed consent for the study.
- •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
排除标准
- •- Patients aged below 21 years,
- •- Contraindication to oral anticoagulation,
- •- Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous [IV]),
- •- Women of childbearing potential without adequate birthcontrol; pregnant women; breastfeeding women,
- •- Clinically relevant haematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease,
- •- Serum potassium < 3.5 mmol/l and uncorrected or > 5.5 mmol/l before randomization,
- •- History of torsades de pointes; first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease,
- •- History of high degree atrio-ventricular block (2nd degree Mobitz 2 or higher), or significant sinus node disease (documented pause of 3 sec or more) without a permanent pacemaker implanted,
- •- Bradycardia < 50 beats per minute (bpm) on the last 12-lead electrocardiogram (ECG) before randomization,
- •- Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization,
- •- Ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator,
- •- Patients known to have chronic AF defined as continuous AF for more than 12 months,
- •- Long QT syndrome or QT- or QTc-interval > or = 500 msecs before randomization,
- •- Wolff-Parkinson-White Syndrome,
- •- Patients with atrial flutter; patients with paroxysmal AF,
- •- Hyperthyroidism; hypothyroidism; other contraindications to amiodarone,
- •- Treatment with other Class I or III antiarrhythmic drugs.
研究者
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