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Deep vein thrombosis (DVT)is devastating disease which influencing the mortality and morbidity of patients at-risk like those undergoing orthopedic surgery.
Recent publication suggested HMO-co-A reductase inhibitor (statin) may reduce the occurrence rate of venous thromboembolism in apparently healthy persons.
The pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may have effect on the positive results.
We are investigating whether rosuvastatin is associated with lower incidence of deep vein thrombosis (DVT) in patients undergoing total knee replacement arthroplasty(TKRA)who are at-high risk for developing DVT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Rosuvastatin + enoxaparin arm | Experimental | Rosuvastatin 20mg/day for 7days before and 7days after index surgery (total knee replacement arthroplasty, TKRA) Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered at the same time with rosuvastatin. |
|
| enoxaparin only | Active Comparator | enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20mg/d for 14days | Drug | Rosuvastatin 20mg/day for 7days before and 7days after index surgery (total knee replacement arthroplasty, TKRA) Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered at the same time with rosuvastatin. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities | 7days after index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP | 7days, 1month, 2month after index surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Ho Jo, MD | Contact | 82-31-380-3722 | sophi5@medimail.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang-Ho Jo, MD | Hallym University Medical Center | Principal Investigator |
| Sang-Ho Jo, MD | Hallym University Medical Center | Study Director |
| Young-Jin Choi, MD |
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23629822 | Derived | Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29. | |
| 21684353 | Derived | Park WJ, Jo SH, Kim SA, Kim HS, Han SJ, Choi YJ, Rhim CY. Rationale and design of STOP DVT study: rosuvastatin for the prevention of deep vein thrombosis in patients undergoing total knee replacement arthroplasty--a prospective randomized open-label controlled trial. Contemp Clin Trials. 2011 Sep;32(5):779-82. doi: 10.1016/j.cct.2011.06.001. Epub 2011 Jun 12. |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| enoxaparin only | Drug | enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery |
|
| Hallym University Medical Center |
| Study Chair |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |