Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users (Re-STOP DVT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01063426|
Recruitment Status : Unknown
Verified February 2010 by Hallym University Medical Center.
Recruitment status was: Recruiting
First Posted : February 5, 2010
Last Update Posted : February 5, 2010
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 or disease||Intervention/treatment||Phase|
|Thrombosis Prevention Surgery||Drug: High dose Atorvastatin+enoxaparin Drug: Enoxaparin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||March 2012|
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
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
- Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities [ Time Frame: 7days after index surgery ]
- D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP [ Time Frame: 7days, 1month, 2month after index surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063426
|Contact: Sang-Ho Jo, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Sang-Ho Jo, MD||Hallym University Medical Center|
|Study Chair:||Sang-Ho Jo, MD||Hallym University Medical Center|