EUCTR2010-019791-73-NL进行中（未招募）1 期
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10,800
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
- •Permanent AF defined by the presence of all of the following criteria:
- •- Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter
- •- Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization
- •- No evidence of sinus rhythm in the period between these two documentations of AF
- •- Patient and physician decision to allow AF to continue without further efforts to restore sinus rhythm
- •Patients aged 65 years or older with at least one of the following risk criteria:
- •- Coronary artery disease
- •- Prior stroke or Transient Ischemic Attack (TIA)
- •- Symptomatic heart failure
- •- Left ventricular ejection fraction less or equal to 0.40
- •- Peripheral arterial occlusive disease
- •- Aged 75 years or older with both hypertension and diabetes mellitus
- •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
- •- Paroxysmal AF
- •- Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm
- •- Heart failure of New-York Heart Association (NYHA) class IV or recent unstable NYHA class III
研究者
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