Rosuvastatin for Preventing Deep Vein Thrombosis

Brief Summary

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

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: December 2011

Interventions Used in this Clinical Trial

  • Drug: Rosuvastatin 20mg/d for 14days
    • 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: enoxaparin only
    • enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 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.
  • Active Comparator: enoxaparin only
    • enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery

Outcome Measures for this Clinical Trial

Primary Measures

  • Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
    • Time Frame: 7days after index surgery
      Safety Issue?: Yes

Secondary Measures

  • D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP
    • Time Frame: 7days, 1month, 2month after index surgery
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Hallym University Medical Center
  • Provider of Information About this Clinical Study
    • Hallym University Sacred Heart Hospital, Department of Internal Medicine, Division of Cardiology, Hallym University Sacred Heart Hospital
  • Overall Official(s)
    • Sang-Ho Jo, MD, Principal Investigator, Hallym University Medical Center
    • Sang-Ho Jo, MD, Study Director, Hallym University Medical Center
    • Young-Jin Choi, MD, Study Chair, Hallym University Medical Center
  • Overall Contact(s)
    • Sang-Ho Jo, MD, 82-31-380-3722, sophi5@medimail.co.kr

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01021488