Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users Undergoing Total Knee Replacement Arthroplasty: RE-STOP-DVT Study- A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
研究概览
简要总结
Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty.
A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property.
We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are going to receive total knee replacement arthroplasty from any cause.
- •< 19 years old
排除标准
- •patients with cancer
- •Patients receiving anticoagulant agents from any cause
- •current statin users
- •expecting survival from other co-morbidity < 1year
- •Bed ridden patient
- •AST, ALT > 3times of upper normal limit
- •CK> upper normal limit
- •pregnancy
- •patients who receives hormone replacement therapy
研究组 & 干预措施
Atorvastatin + enoxaparine arm
High dose atorvastatin arm before index surgery+ conventional enoxaparin
干预措施: High dose Atorvastatin+enoxaparin (Drug)
Conventional Enoxaprin
Conventional Enoxaparin before 12hr and on 1-7th day after index surgery
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
时间窗: 7days after index surgery
次要结局
- D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP(7days, 1month, 2month after index surgery)