Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - 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
Deep vein thrombosis (DVT)is devastating disease which influencing the mortality and morbidity of patients at-risk like those undergoing orthopedic surgery.
Recent publication suggested HMO-co-A reductase inhibitor (statin) may reduce the occurrence rate of venous thromboembolism in apparently healthy persons.
The pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may have effect on the positive results.
We are investigating whether rosuvastatin is associated with lower incidence of deep vein thrombosis (DVT) in patients undergoing total knee replacement arthroplasty(TKRA)who are at-high risk for developing 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
Experimental: Rosuvastatin + enoxaparin arm
Rosuvastatin 20mg/day for 7days before and 7days after index surgery (total knee replacement arthroplasty, TKRA) Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered at the same time with rosuvastatin.
干预措施: Rosuvastatin 20mg/d for 14days (Drug)
enoxaparin only
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
干预措施: enoxaparin only (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)