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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombosis Prevention Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atorvastatin + enoxaparine arm

High dose atorvastatin arm before index surgery+ conventional enoxaparin

Group Type EXPERIMENTAL

High dose Atorvastatin+enoxaparin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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.

Intervention Type DRUG

Enoxaparin

Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-Ho Jo, MD

Role: CONTACT

82-31-380-3722

Facility Contacts

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Sang-Ho Jo, MD

Role: primary

82-31-380-3722

Other Identifiers

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2009-I055

Identifier Type: -

Identifier Source: org_study_id

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