NCT01570530终止3 期
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery
Fundación General Universidad de Valladolid2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.
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
- None
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
- •Men and women over 18 year-old.
- •In sinus rhythm.
- •Affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
- •Women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.
排除标准
- •Urgent surgery.
- •Surgery due to endocarditis.
- •Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
- •Treatment with beta-blockers at time of randomization
- •Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
- •Chronic using of NSAIDs and / or corticosteroids at time of randomization
- •Uncontrolled thyroid disease.
- •Active liver disease and / or history of previous chronic liver disease.
- •Alcoholism.
- •Predisposing factors to statins adverse effects:
- •Increased transaminase levels at baseline (x3 normal value).
- •Renal failure (creatinine levels over 2 mg/dl).
- •Previous diagnosis of myopathy of any etiology.
- •Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
- •In women of childbearing age, positive pregnancy test the day of inclusion in the study.
- •Not signed informed consent.
- •Inability to understand objectives of the study.
- •Exclusion criteria of the study once started:
- •Withdrawal of patient's consent.
- •Modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
结局指标
主要结局
Number of patients with postoperative atrial fibrillation(atorvastatin and control groups)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
To evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs or statins.
次要结局
- Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation.(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery.(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery.(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance.(Participants will be followed for the duration of hospital day, an expected average of 10 days.)
- Changes in biochemical markers in both groups.(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- Changes in echocardiographic parameters in both groups.(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
研究者
研究点 (2)
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