EUCTR2009-018215-53-NL进行中（未招募）不适用
The effect of the addition of dronedarone to, versus increase of, existing conventional rate control medication on ventricular rate during paroxysmal or persistent atrial fibrillation (AFRODITE study) - AFDRODITE
sanofi-aventis Netherlands0 个研究点开始时间: 2009年12月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Paroxysmal or persistent AF (according to ACC/AHA/ESC 2006 definition) with HR >80 bpm at rest despite treatment with =2 rate control agents (i.e. beta blocker and/or calcium antagonist). Patients using digoxin are eligible.
- •Documented AF at randomisation or documented AF in the past 24 hours.
- •Treated with the following rate control medication:
- •-beta blocker or
- •-calcium antagonist or
- •-beta blocker plus calcium antagonist or
- •-beta blocker plus digoxin or
- •-calcium antagonist plus digoxin.
- •> 45 years of age.
- •Anticoagulant treatment in line with local guidelines.
- •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
- •Incapacitated patients.
- •Permanent AF (according to ACC/AHA/ESC 2006 definition).
- •Use of class I or III AADs.
- •Patients scheduled for cardioversion or pulmonary vein ablation.
- •Unstable NYHA class III and all class IV HF.
- •AV block grade 2 or 3.
- •Known severe renal impairment (serum creatinine >180 µmol/l).
- •Known severe hepatic impairment (AST, ALT >3x ULN).
- •Contra-indication for dronedarone.
- •Participation in a clinical drug study in the 3 months prior to inclusion.
- •Women of childbearing potential, who do not use adequate contraception (in the opinion of the investigator).
- •Lactating women.
研究者
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