Rosuvastatin for Preventing Deep Vein Thrombosis

Phase 4

• Conditions: Deep Vein Thrombosis; Venous; Thrombosis; Prevention
• Interventions: Drug: Rosuvastatin 20mg/d for 14days; Drug: enoxaparin only

• Registration Number: NCT01021488
• Lead Sponsor: Hallym University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-11-30
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Rosuvastatin + enoxaparin arm	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.
enoxaparin only	enoxaparin only	enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery

Primary Outcome Measures

Name	Time	Method
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities	7days after index surgery

Secondary Outcome Measures

Name	Time	Method
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP	7days, 1month, 2month after index surgery

Trial Locations

Locations (1)

Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of