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Rosuvastatin for Preventing Deep Vein Thrombosis (STOP-DVT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Hallym University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021488
First Posted: November 30, 2009
Last Update Posted: October 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hallym University Medical Center
  Purpose

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


Condition Intervention Phase
Deep Vein Thrombosis Venous Thrombosis Prevention Drug: Rosuvastatin 20mg/d for 14days Drug: enoxaparin only Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities [ Time Frame: 7days after index surgery ]

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

Estimated Enrollment: 180
Study Start Date: October 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021488


Contacts
Contact: Sang-Ho Jo, MD 82-31-380-3722 sophi5@medimail.co.kr

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery Recruiting
Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
Contact: Sang-Ho Jo, MD    82-31-380-3722    sophi5@medimail.co.kr   
Contact: mikyung Baek    82-31-380-1975    mikyungb@hallym.or.kr   
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hallym University Sacred Heart Hospital, Department of Internal Medicine, Division of Cardiology, Hallym University Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01021488     History of Changes
Other Study ID Numbers: 2009-I053
First Submitted: November 25, 2009
First Posted: November 30, 2009
Last Update Posted: October 5, 2011
Last Verified: November 2009

Keywords provided by Hallym University Medical Center:
Thrombosis
Vein
Statin
Prevention

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors