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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2009-10-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Rosuvastatin + enoxaparin arm
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.
Rosuvastatin 20mg/d for 14days
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
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
enoxaparin only
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rosuvastatin 20mg/d for 14days
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
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Hallym University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hallym University Sacred Heart Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sang-Ho Jo, MD
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center
Sang-Ho Jo, MD
Role: STUDY_DIRECTOR
Hallym University Medical Center
Young-Jin Choi, MD
Role: STUDY_CHAIR
Hallym University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
Anyang-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-I053
Identifier Type: -
Identifier Source: org_study_id