Rosuvastatin for Preventing Deep Vein Thrombosis (STOP-DVT)

October 4, 2011 updated by: Hallym University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
        • Recruiting
        • Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Rosuvastatin + enoxaparin arm
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.
Drug: Rosuvastatin 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.
Active Comparator: enoxaparin only
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
Drug: enoxaparin only
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Principal Investigator: Sang-Ho Jo, MD, Hallym University Medical Center
  • Study Director: Sang-Ho Jo, MD, Hallym University Medical Center
  • Study Chair: Young-Jin Choi, MD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-I053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thrombosis

Clinical Trials on Rosuvastatin 20mg/d for 14days

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe