title: Rationale and design of STOP DVT study: rosuvastatin for the prevention of deep vein thrombosis in patients undergoing total knee replacement arthroplasty--a prospective randomized open-label controlled trial.
abstract: BACKGROUND
  Deep vein thrombosis (DVT) frequently occurs in high-risk cardiovascular patients receiving orthopedic surgery, despite prophylactic measures for its prevention. Statins, a class of drugs used to lower cholesterol levels, have been reported to help prevent the development of DVT.
  
  
  METHODS
  We will conduct a prospective randomized clinical trial to compare the effects of high-dose rosuvastatin plus a low-molecular-weight heparin (LMWH), enoxaparin, with conventional LMWH therapy in the prevention of DVT. Patients will be naive to both statins and anti-coagulants and then underwent total knee replacement arthroplasty (TKRA). In total, 180 patients will be randomized into two groups of 90, consisting of a LMWH group (40 mg enoxaparin subcutaneously beginning at 12h prior to surgery and continuing for 7 days every 24h after surgery) and a statin plus LMWH group (20mg rosuvastatin orally for 14 days, 7 days before and after surgery in combination with LMWH). All patients will undergo computed tomography angiography of both extremities 7 days after index surgery to assess the development of DVT.
  
  
  CONCLUSIONS
  DVT remains prevalent despite the use of conventional prophylactic measures, in part because certain patients (particularly the elderly) are unable to receive preventive treatment because of a high risk of bleeding complications and co-morbidity. Statins have been shown to have beneficial effects in arterial atherothrombosis and are frequently administered to elderly patients to treat coronary artery. We hypothesize that peri-operative statin treatment may be beneficial in those patients restricted from the conventional prophylaxis for DVT.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, Republic of Korea.
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Park
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Jo
authors.forename: Sung-Ai
authors.initials: SA
authors.lastname: Kim
authors.forename: Hyun-Sook
authors.initials: HS
authors.lastname: Kim
authors.forename: Sang-Jin
authors.initials: SJ
authors.lastname: Han
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Choi
authors.forename: Chong-Yun
authors.initials: CY
authors.lastname: Rhim
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects* / Q000379:methods; D004359:Drug Therapy, Combination; D017984:Enoxaparin / Q000627:therapeutic use; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D016015:Logistic Models; D019637:Orthopedic Procedures / Q000009:adverse effects / Q000379:methods; D011743:Pyrimidines / Q000627:therapeutic use*; D012107:Research Design; D018570:Risk Assessment; D000068718:Rosuvastatin Calcium; D018401:Sample Size; D013449:Sulfonamides / Q000627:therapeutic use*; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000517:prevention & control / Q000601:surgery
chemical_list: D017984:Enoxaparin; D005464:Fluorobenzenes; D006495:Heparin, Low-Molecular-Weight; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium