NCT00457340已完成4 期
Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.10 个研究点 分布在 2 个国家目标入组 220 人开始时间: 2000年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 10
- 主要终点
- To assess in patients with CAD and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia after randomisation.
研究概览
简要总结
To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation requiring ICD [implantable cardioverter defibrillator] intervention) within one year after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects were male or female subjects, age >18 years, with clinically documented coronary artery disease and life-threatening ventricular arrhythmias who met the following criteria:
- •Were scheduled for an ICD implantation or had an ICD implantation within 1 month, according to the class I American College of Cardiology/American Heart Association (ACC/AHA) practice guidelines for ICD therapy
- •Were already treated with an ICD for a class I ACC/AHA indication for more than one month, provided they received at least one appropriate ICD intervention (shock or antitachycardia pacing (ATP) for ventricular tachycardia or ventricular fibrillation) during the preceding six months
排除标准
- •Patients with ventricular arrhythmias in the acute phase of myocardial infarction (first 48 hours).
- •Patients with incessant ventricular tachycardia.
- •Patients with ventricular arrhythmias without underlying coronary artery disease.
- •Patients with a transient or reversible cause of ventricular arrhythmias (including significant electrolyte disturbances or drug induced proarrhythmia).
结局指标
主要结局
To assess in patients with CAD and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia after randomisation.
次要结局
- Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm.
- Combined total mortality and major cardiovascular events.
- Major cardiovascular events include acute myocardial infarction, stroke and PTCA [percutaneous coronary angioplasty] (with or without stenting) or CABG [coronary artery bypass graft] (CABG already foreseen at the moment of randomization).
- An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention.
- Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias.
研究者
研究点 (10)
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