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

Primary Purpose

Thrombosis, Prevention, Surgery

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose Atorvastatin+enoxaparin
Enoxaparin
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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

Atorvastatin + enoxaparine arm

Conventional Enoxaprin

Arm Description

High dose atorvastatin arm before index surgery+ conventional enoxaparin

Conventional Enoxaparin before 12hr and on 1-7th day 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

First Posted
February 4, 2010
Last Updated
February 4, 2010
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01063426
Brief Title
Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users
Acronym
Re-STOP DVT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 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
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Prevention, Surgery
Keywords
Statin, Vein

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
Atorvastatin + enoxaparine arm
Arm Type
Experimental
Arm Description
High dose atorvastatin arm before index surgery+ conventional enoxaparin
Arm Title
Conventional Enoxaprin
Arm Type
Active Comparator
Arm Description
Conventional Enoxaparin before 12hr and on 1-7th day after index surgery
Intervention Type
Drug
Intervention Name(s)
High dose Atorvastatin+enoxaparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
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
No
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
Email
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 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
Email
sophi5@medimail.co.kr

12. IPD Sharing Statement

Learn more about this trial

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

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