Rosuvastatin for Preventing Deep Vein Thrombosis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01021488

Acronym

STOP-DVT

Enrollment

180

Registered

2009-11-30

Start date

2009-10-31

Completion date

2012-03-31

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Prevention, Thrombosis, Venous

Keywords

Thrombosis, Vein, Statin, Prevention

Brief 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

Interventions

DRUGRosuvastatin 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.

DRUGenoxaparin only

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities	7days after index surgery

Secondary

Measure	Time frame
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP	7days, 1month, 2month after index surgery

Countries

South Korea

Contacts

Primary ContactSang-Ho Jo, MD

sophi5@medimail.co.kr82-31-380-3722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026