CTRI/2011/06/001844Other3 期
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400 mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - PALLAS
SanofiSynthelabo India Limited0 个研究点目标入组 10,800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 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
入排标准
入选标准
- •1. Patients in permanent atrial fibrillation with additional risk
- •2. Patients in permanent atrial fibrillation defined by the
- •presence of all of the following criteria:
- •1. Availability of one 12-lead ECG not more than 14
- •days prior to randomization, showing that the patient
- •is in atrial fibrillation or atrial flutter
- •2. Availability of documentation (including either rhythm
- •strips or medical report of the rhythm) showing that
- •the patient was in atrial fibrillation or atrial flutter at
- •least 6 months prior to randomization
- •3. No evidence of sinus rhythm in the period between
- •these two documentations of atrial fibrillation
- •4. Patient and physician decision to allow atrial
- •fibrillation to continue without further efforts to restore
- •sinus rhythm
- •5.Patients aged 65 years or older with at least one of the
- •following risk factors or combination of risk factors:
- •1.Coronary artery disease
- •2. Prior stroke or TIA
- •3. Symptomatic heart failure
- •4. Left ventricular ejection fraction less than or equal to
- •5. Peripheral arterial occlusive disease
- •6. Aged 75 years or older with both hypertension and
- •diabetes mellitus
排除标准
- •Exclusion Criteria (selection)
- •E 01. Patients in paroxysmal atrial fibrillation
- •E 02. Patients in persistent atrial fibrillation without a decision to
- •allow atrial fibrillation to continue without further efforts to
- •restore sinus rhythm
- •E 11. Patients with heart failure of NYHA class IV or recent
- •unstable NYHA class III
研究者
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