Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rosuvastatin for Preventing Deep Vein Thrombosis (STOP-DVT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01021488
First received: November 25, 2009
Last updated: October 4, 2011
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hallym University Medical Center

Additional 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
Study First Received: November 25, 2009
Last Updated: October 4, 2011
Health Authority: Korea: Ministry for Health and Welfare

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

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

ClinicalTrials.gov processed this record on November 20, 2014