Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01063426
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty.

A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property.

We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.


Condition Intervention Phase
Thrombosis
Prevention
Surgery
Drug: High dose Atorvastatin+enoxaparin
Drug: Enoxaparin
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: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users Undergoing Total Knee Replacement Arthroplasty: RE-STOP-DVT Study- 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: No ]

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: November 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: Atorvastatin + enoxaparine arm
High dose atorvastatin arm before index surgery+ conventional enoxaparin
Drug: High dose Atorvastatin+enoxaparin
High dose atorvastatin 80mg/day for 7days after index surgery (total knee replacement arthroplasty, TKRA). At the same time Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered.
Active Comparator: Conventional Enoxaprin
Conventional Enoxaparin before 12hr and on 1-7th day after index surgery
Drug: Enoxaparin
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.

  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: NCT01063426

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   
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Principal Investigator: Sang-Ho Jo, MD Hallym University Medical Center
Study Chair: Sang-Ho Jo, MD Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center, Hallym University Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01063426     History of Changes
Other Study ID Numbers: 2009-I055
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Hallym University Medical Center:
Statin
Vein

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

ClinicalTrials.gov processed this record on September 22, 2014