NCT01425398已完成3 期
A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Improved Inflammatory Markers
研究概览
简要总结
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Single or multiple valve repairs or replacements without coronary artery bypass grafting
- •Bentall procedure, but no other aortic procedures
- •With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)
排除标准
- •Age under 18 years old
- •Urgent or emergency surgery
- •Unable to provide consent
- •Presently on statin therapy or exposure to statins within a month of surgery
- •Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
- •Known hypersensitivity to rosuvastatin
- •Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
- •Pregnant or nursing women
- •On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
- •Creatinine clearance < 30 ml/min/1.73 m2
- •Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
- •Human Immunodeficiency Virus
研究组 & 干预措施
Rosuvastatin
Experimental
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
干预措施: Rosuvastatin (Drug)
Placebo
Placebo Comparator
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5
干预措施: Placebo (Drug)
结局指标
主要结局
Improved Inflammatory Markers
时间窗: Within 5 days post-op and at 3 months
Significant (p\<0.05) improvement of measured inflammatory markers
次要结局
- Stroke(Within 3 months)
- Mortality(Within 3 months)
- ICU length of stay(3 months)
- Myocardial Infarction(Within 3 months)
研究者
Jacques Genest
Co-Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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