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

Hallym University

Status and phase: Unknown; Phase 4

Conditions: Prevention; Surgery; Thrombosis

Treatments: Drug: Enoxaparin; Drug: High dose Atorvastatin+enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01063426

2009-I055

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Atorvastatin + enoxaparine arm

Experimental group

Description:

High dose atorvastatin arm before index surgery+ conventional enoxaparin

Treatment:

Drug: High dose Atorvastatin+enoxaparin

Conventional Enoxaprin

Active Comparator group

Description:

Conventional Enoxaparin before 12hr and on 1-7th day after index surgery

Treatment:

Drug: Enoxaparin