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Rosuvastatin for Preventing Deep Vein Thrombosis (STOP-DVT)

Primary Purpose

Deep Vein Thrombosis, Venous, Thrombosis

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Rosuvastatin 20mg/d for 14days

enoxaparin only

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis focused on measuring Thrombosis, Vein, Statin, Prevention

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Rosuvastatin + enoxaparin arm

enoxaparin only

Arm 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.

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

Outcomes

Primary Outcome Measures

Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities

Secondary Outcome Measures

D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP

Full Information

NCT ID

NCT01021488

First Posted

November 25, 2009

Last Updated

October 4, 2011

Sponsor

Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01021488

Brief Title

Rosuvastatin for Preventing Deep Vein Thrombosis

Acronym

STOP-DVT

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

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hallym University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis, Venous, Thrombosis, Prevention

Keywords

Thrombosis, Vein, Statin, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Rosuvastatin + enoxaparin arm

Arm Type

Experimental

Arm Description

Arm Title

enoxaparin only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 20mg/d for 14days

Intervention Description

Intervention Type

Drug

Intervention Name(s)

enoxaparin only

Intervention Description

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

Primary Outcome Measure Information:

Title

Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities

Time Frame

7days after index surgery

Secondary Outcome Measure Information:

Title

D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP

Time Frame

7days, 1month, 2month after index surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang-Ho Jo, MD

Phone

82-31-380-3722

sophi5@medimail.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Ho Jo, MD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sang-Ho Jo, MD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Young-Jin Choi, MD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery

City

Anyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

431-070

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang-Ho Jo, MD

Phone

82-31-380-3722

sophi5@medimail.co.kr

First Name & Middle Initial & Last Name & Degree

mikyung Baek

Phone

82-31-380-1975

mikyungb@hallym.or.kr

12. IPD Sharing Statement

Citations:

PubMed Identifier

23629822

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.

Results Reference

derived

PubMed Identifier

21684353

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.

Results Reference

derived

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Rosuvastatin for Preventing Deep Vein Thrombosis

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