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

Phase 4

• Conditions: Thrombosis; Prevention; Surgery
• Interventions: Drug: High dose Atorvastatin+enoxaparin; Drug: Enoxaparin

• Registration Number: NCT01063426
• Lead Sponsor: Hallym University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Last Update Submitted: 2010-02-04
• Study First Posted: 2010-02-05
• Last Update Posted: 2010-02-05
• 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
Atorvastatin + enoxaparine arm	High dose Atorvastatin+enoxaparin	High dose atorvastatin arm before index surgery+ conventional enoxaparin
Conventional Enoxaprin	Enoxaparin	Conventional Enoxaparin before 12hr and on 1-7th day 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