Deep Vein ThrombosisPhase 4STOP-DVTNCT01021488
Rosuvastatin for Preventing Deep Vein Thrombosis
A Phase 4 study testing Rosuvastatin 20mg/d for 14days and enoxaparin only in people with Deep Vein Thrombosis and Venous, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Venous, Thrombosis
- What is being tested?
- Rosuvastatin 20mg/d for 14days and enoxaparin only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are going to receive total knee replacement arthroplasty from any cause.
- < 19 years old
Who cannot join
- 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
Show all 9Show fewer
- CK> upper normal limit
- pregnancy
- patients who receives hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
Anyang-si, Gyeonggi-do, 431-070
Sang-Ho Jo, MD, 82-31-380-3722, sophi5@medimail.co.kr
mikyung Baek, 82-31-380-1975, mikyungb@hallym.or.kr
About this study
Official title: Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial
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
- Conditions
- Deep Vein Thrombosis, Venous, Thrombosis, Prevention
- Being tested
- Rosuvastatin 20mg/d for 14days, enoxaparin only
- Keywords
- Thrombosis, Vein, Statin, Prevention
- Medical subject headings
- Venous Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20mg/d for 14daysDrug
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 onlyDrug
enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rosuvastatin 20mg/d for 14days |
| enoxaparin only | Active comparator | enoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery Receives: Drug: enoxaparin only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
Measured: 7days after index surgery
Secondary outcomes (1)
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP
Measured: 7days, 1month, 2month after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sang-Ho Jo, MD, Principal investigator, Hallym University Medical CenterSang-Ho Jo, MD, Study director, Hallym University Medical CenterYoung-Jin Choi, MD, Study chair, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021488
- Sponsor's protocol ID
- 2009-I053
- Acronym
- STOP-DVT
- Status last verified
- Nov 2009
- First submitted
- 25 Nov 2009
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23629822Park 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.
PubMed 21684353
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01021488
- Acronym / sponsor ID
- STOP-DVT / 2009-I053
- Conditions
- Deep Vein Thrombosis, Venous, Thrombosis, Prevention
- Keywords
- Thrombosis, Vein, Statin, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Rosuvastatin + enoxaparin arm | Experimental | Drug: Rosuvastatin 20mg/d for 14daysRosuvastatin 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 | Drug: enoxaparin onlyenoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are going to receive total knee replacement arthroplasty from any cause.
- < 19 years old
Key exclusion criteria (9 listed)
- patients with cancer
- Patients receiving anticoagulant agents from any cause
- current statin users
- expecting survival from other co-morbidity < 1year
- Bed ridden patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20mg/d for 14daysRosuvastatin 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. | Drug | Experimental: Rosuvastatin + enoxaparin arm |
| enoxaparin onlyenoxaparin 40mg sq/day only starting 12hr before TKRA and from on day 1 to 7 after index surgery | Drug | enoxaparin only |
Primary outcome
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
Time frame: 7days after index surgery
1 secondary outcome
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP
Time frame: 7days, 1month, 2month after index surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
- Derived from this study: PubMed 23629822Lippi 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.
- Derived from this study: PubMed 21684353Park 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Ho Jo, MD principal investigator
Hallym University Medical Center
Sang-Ho Jo, MD study director
Hallym University Medical Center
Young-Jin Choi, MD study chair
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 20mg/d for 14days and enoxaparin only in people with Deep Vein Thrombosis and Venous, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Ho Jo, MD (82-31-380-3722, sophi5@medimail.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities (time frame: 7days after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021488, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011; AzTrials last refreshed its copy on 1 Nov 2026.