A Double Blinded, Randomized Study Comparing the Effectiveness of Fish Oil Supplements, Oral Statins, and Placebo in Reducing the Incidence of Atrial Fibrillation Following a Lung Resection in Patients With Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidences of Atrial Fibrillation During First 4 Days After Lung Resection
研究概览
简要总结
The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil supplements can help to control side effects of the heart that are commonly seen after lung surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs is more effective than the other at controlling side effects.
详细描述
The Study Drugs:
Atorvastatin is designed to lower cholesterol by blocking its production in the liver. This may help to decrease the chances of having a heart attack or a stroke.
Fish oil supplements are designed to lower fat levels in the blood by blocking their production in the liver. This may help to decrease the chances of having a heart attack or a stroke.
Atorvastatin is FDA-approved and commercially available for lowering cholesterol or fat levels in the blood. Fish oil supplements are also commercially available.
Researchers want to compare the anti-inflammatory effects of Atorvastatin and fish oil supplements.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be in a normal sinus rhythm preoperatively.
- •Participants undergoing planned lobectomy and 60 years of age or older or participants undergoing planned pneumonectomy and 18 years of age or older.
- •Planned procedure is 5 days after the start of taking study drugs.
- •Signed written informed consent
- •Women of childbearing potential must have a negative pregnancy test (A woman of childbearing potential is a women who has not been naturally postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization)
- •Adequate liver function evidenced by; aspartate aminotransferase (AST or SGOT) </= 2.5 * Upper Limits of Normal (ULN), and alanine aminotransferase (ALT or SGPT) </= 2.5 * ULN
排除标准
- •Any history of supraventricular arrhythmia for which the patient is taking medications.
- •Current use of antiarrhythmic medications other than beta-receptor antagonists, calcium-channel antagonists, or digitalis.
- •Use of any supplemental n-3 fatty acids during the previous three months.
- •Use of any statin therapy during the previous three months.
- •Patients known to have a history of recent drug or alcohol abuse.
- •Known allergy to seafood
- •Current use of Gemfibrozil and Fenofibrate.
研究组 & 干预措施
Atorvastatin
1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
干预措施: Atorvastatin (Drug)
Atorvastatin
1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
干预措施: Placebo (Other)
Fish Oil Supplement
3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
干预措施: Fish Oil Supplement (Dietary Supplement)
Fish Oil Supplement
3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
干预措施: Placebo (Other)
Placebo
4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Incidences of Atrial Fibrillation During First 4 Days After Lung Resection
时间窗: Baseline to 4 days post surgery
New onset of sustained (15 min or \>) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.
次要结局
未报告次要终点