Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mortality ; myocardial infarction ; stroke
研究概览
简要总结
This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.
Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)
排除标准
- •Pregnant or lactating women
- •Patient with sensitivity to atorvastatin
- •Patient has elevations in certain laboratory values (CK, AST, ALT)
- •Known history of active hepatic disease or known hepatic insufficiency
- •Patients participating in another clinical trial
- •Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
- •Serious infectious disease after surgery
- •Known history of cancer
研究组 & 干预措施
1
Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60
干预措施: Atorvastatin (Drug)
2
Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60
干预措施: Atorvastatin (Drug)
结局指标
主要结局
mortality ; myocardial infarction ; stroke
时间窗: within 90 days after surgery
次要结局
- Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects(within 24h before surgery)
- Change and percent change from baseline to the surgery of treatment for hs-CRP(within 24h before surgery)
- Safety of atorvastatin through laboratory assessment(within 24h before surgery)