Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurrence of atrial fibrillation by hospital discharge
研究概览
简要总结
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.
详细描述
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 or older
- •Undergoing elective cardiothoracic surgery
排除标准
- •Emergency cardiothoracic surgery
- •History of permanent atrial fibrillation
- •Acute coronary syndrome within 7 days
- •Antiarrhythmic drug use in the past 3 months
- •Receiving maximal tolerated dose of statin therapy
- •Receiving fibrate therapy
- •History of statin intolerance
- •Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)>2x ULN)
- •Serum Creatinine > 3 mg/dl
- •Pregnancy or breastfeeding
研究组 & 干预措施
Atorvastatin 20 mg
atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery
干预措施: Atorvastatin 20 mg (Drug)
Atorvastatin 80 mg
atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery
干预措施: Atorvastatin 80 mg (Drug)
结局指标
主要结局
Occurrence of atrial fibrillation by hospital discharge
时间窗: Hospital discharge, an expected 5-7 days
Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings.
次要结局
- Length of hospital stay(Hospital discharge, an expected 5-7 days)
- Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days(30 days)