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

Surgery Clinical Trial

— Re-STOP DVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01063426
• Other study ID #: 2009-I055
• Status: Recruiting
• Phase: Phase 4
• First received: February 4, 2010
• Last updated: February 4, 2010
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2010
• 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

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.

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

• Prevention
• Surgery
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• High dose Atorvastatin+enoxaparin
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.
• Enoxaparin
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.

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	No
Secondary	D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP		7days, 1month, 2month after index surgery	Yes