Rosuvastatin for Preventing Deep Vein Thrombosis

Study Overview
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Brief Summary
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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

Official Title
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Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial

Conditions
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Deep Vein Thrombosis, Venous, Thrombosis, Prevention

Intervention / Treatment
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* Drug: Rosuvastatin 20mg/d for 14days
* Drug: enoxaparin only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are going to receive total knee replacement arthroplasty from any cause. < 19 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Rosuvastatin + enoxaparin arm<br>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. | Drug: Rosuvastatin 20mg/d for 14days<br>* 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.<br>|
| Active Comparator: enoxaparin only<br>enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery | Drug: enoxaparin only<br>* enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities |  | 7days after index surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP |  | 7days, 1month, 2month after index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombosis, Vein, Statin, Prevention