Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months
研究概览
简要总结
To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP) values in the blood.
详细描述
Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.
There is growing evidence that inflammation may be involved in the pathogenesis of AF. CRP, a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.
125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.
Patients will have baseline lipids, CRP, endothelial function tests and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > or = to 18 years of age
- •Clinically indicated left atrial ablation procedure for atrial fibrillation
排除标准
- •Known malignancy
- •Known inflammatory disease
- •Surgery or trauma or myocardial infarction in the previous month
- •Known contraindication to statin therapy
- •Elevated liver enzymes above two times the upper limit of normal
- •Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization
研究组 & 干预措施
Atorvastatin
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
干预措施: Atorvastatin (Drug)
Placebo
Placebo (dummy) tablet taken once daily by mouth for 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months
时间窗: Baseline through 3 months
Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).
次要结局
- Change in Lipid Levels(Baseline and 3 months)
- Percentage of Subjects Without Atrial Arrhythmia at 3 Months(Baseline through 3 months)
- Change in Mean C-Reactive Protein Level(Baseline and 3 months)
- Change in Mean Quality of Life Score(Baseline and 3 months)