Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thrombosis, Prevention, Surgery

Intervention / Treatment
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* Drug: High dose Atorvastatin+enoxaparin
* Drug: Enoxaparin


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: Atorvastatin + enoxaparine arm<br>High dose atorvastatin arm before index surgery+ conventional enoxaparin | Drug: High dose Atorvastatin+enoxaparin<br>* High dose atorvastatin 80mg/day for 7days after index surgery (total knee replacement arthroplasty, TKRA). At the same time Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered.<br>|
| Active Comparator: Conventional Enoxaprin<br>Conventional Enoxaparin before 12hr and on 1-7th day after index surgery | Drug: Enoxaparin<br>* Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.<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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Statin, Vein