Clinical trial NCT01021488: Rosuvastatin for Preventing Deep Vein Thrombosis
Official title: Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Venous
Thrombosis
Prevention
Keywords: Thrombosis
Vein
Statin
Prevention
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2009-11-30
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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


Eligibility criteria: 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

Primary outcomes:
measure: Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
timeFrame: 7days after index surgery
Secondary outcomes:
measure: D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP
timeFrame: 7days, 1month, 2month after index surgery
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Medical Center
name: Sang-Ho Jo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: Sang-Ho Jo, MD
role: STUDY_DIRECTOR
affiliation: Hallym University Medical Center
name: Young-Jin Choi, MD
role: STUDY_CHAIR
References:
citation: Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29.
citation: Park WJ, Jo SH, Kim SA, Kim HS, Han SJ, Choi YJ, Rhim CY. Rationale and design of STOP DVT study: rosuvastatin for the prevention of deep vein thrombosis in patients undergoing total knee replacement arthroplasty--a prospective randomized open-label controlled trial. Contemp Clin Trials. 2011 Sep;32(5):779-82. doi: 10.1016/j.cct.2011.06.001. Epub 2011 Jun 12.