Rosuvastatin for Preventing Deep Vein Thrombosis (STOP-DVT)

Hallym University

Status and phase: Unknown; Phase 4

Conditions: Prevention; Venous; Thrombosis; Deep Vein Thrombosis

Treatments: Drug: enoxaparin only; Drug: Rosuvastatin 20mg/d for 14days

Study type: Interventional

Funder types: Other

Identifiers

NCT01021488

2009-I053

Details and patient eligibility

About

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

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

Experimental: Rosuvastatin + enoxaparin arm

Experimental group

Description:

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.

Treatment:

Drug: Rosuvastatin 20mg/d for 14days

enoxaparin only

Active Comparator group

Description:

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

Treatment:

Drug: enoxaparin only