Re-STOP DVT: Reload of High Dose Atorvastatin for Prevent... | NCT01063426

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

NCT01063426

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

Feb 5, 2010Estimated

Enrollment

180Estimated

Phase

Phase 4

Conditions

Thrombosis
Prevention
Surgery

Interventions

High dose Atorvastatin+enoxaparin
Enoxaparin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Feb 4, 2010

First Submission Date that Met QC Criteria

Feb 4, 2010

First Posted Date

Feb 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2010

Last Update Posted Date

Feb 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin + enoxaparine arm	Experimental	High dose atorvastatin arm before index surgery+ conventional enoxaparin	Drug: High dose Atorvastatin+enoxaparin
Conventional Enoxaprin	Active Comparator	Conventional Enoxaparin before 12hr and on 1-7th day after index surgery	Drug: Enoxaparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High dose Atorvastatin+enoxaparin	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities		7days after index surgery

Secondary Outcomes

Measure	Description	Time Frame
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP		7days, 1month, 2month after index surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang-Ho Jo, MD	Contact	82-31-380-3722		sophi5@medimail.co.kr

Overall Officials

Name	Affiliation	Role
Sang-Ho Jo, MD	Hallym University Medical Center	Principal Investigator
Sang-Ho Jo, MD	Hallym University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery	Recruiting	Anyang-si	Gyeonggi-do	431-070	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017984	Enoxaparin

Ancestor Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided