Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users
NCT ID: NCT01063426
Last Updated: 2010-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2009-11-30
2012-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Atorvastatin + enoxaparine arm
High dose atorvastatin arm before index surgery+ conventional enoxaparin
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.
Conventional Enoxaprin
Conventional Enoxaparin before 12hr and on 1-7th day after index surgery
Enoxaparin
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
Interventions
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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.
Enoxaparin
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
Eligibility Criteria
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Inclusion Criteria
* \< 19 years old
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Hallym University Medical Center
OTHER
Responsible Party
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Hallym University Sacred Heart Hospital
Principal Investigators
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Sang-Ho Jo, MD
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center
Sang-Ho Jo, MD
Role: STUDY_CHAIR
Hallym University Medical Center
Locations
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Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
Anyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-I055
Identifier Type: -
Identifier Source: org_study_id
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