Rosuvastatin for Preventing Deep Vein Thrombosis

Thrombosis Clinical Trial

— STOP-DVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01021488
• Other study ID #: 2009-I053
• Status: Recruiting
• Phase: Phase 4
• First received: November 25, 2009
• Last updated: October 4, 2011
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: November 2009
• Source: Hallym University Medical Center
• Contact: Sang-Ho Jo, MD
• Phone: 82-31-380-3722
• Email: sophi5[@]medimail.co.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Prevention
• Thrombosis
• Venous
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery	Anyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities		7days after index surgery	Yes
Secondary	D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP		7days, 1month, 2month after index surgery	Yes