ThrombosisPhase 4Re-STOP DVTNCT01063426
Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users
A Phase 4 study testing High dose Atorvastatin+enoxaparin and Enoxaparin in people with Thrombosis and Prevention, run by Hallym University Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thrombosis, Prevention, Surgery
- What is being tested?
- High dose Atorvastatin+enoxaparin and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 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
About this study
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
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.
- Conditions
- Thrombosis, Prevention, Surgery
- Being tested
- High dose Atorvastatin+enoxaparin, Enoxaparin
- Keywords
- Statin, Vein
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose Atorvastatin+enoxaparinDrug
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.
EnoxaparinDrug
Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin + enoxaparine arm | Experimental | High dose atorvastatin arm before index surgery+ conventional enoxaparin Receives: Drug: High dose Atorvastatin+enoxaparin |
| Conventional Enoxaprin | Active comparator | Conventional Enoxaparin before 12hr and on 1-7th day after index surgery Receives: Drug: Enoxaparin |
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 posted5 Feb 2010 (estimated)
- Study startNov 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.
- Other trials for 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 chair, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063426
- Sponsor's protocol ID
- 2009-I055
- Acronym
- Re-STOP DVT
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063426
- Acronym / sponsor ID
- Re-STOP DVT / 2009-I055
- Conditions
- Thrombosis, Prevention, Surgery
- Keywords
- Statin, Vein
- 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
- Nov 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 5 Feb 2010 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin + enoxaparine arm | Experimental | Drug: High dose Atorvastatin+enoxaparinHigh dose atorvastatin arm before index surgery+ conventional enoxaparin |
| Conventional Enoxaprin | Active comparator | Drug: EnoxaparinConventional Enoxaparin before 12hr and on 1-7th day 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 |
|---|---|---|
| High dose Atorvastatin+enoxaparinHigh 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. | Drug | Atorvastatin + enoxaparine arm |
| EnoxaparinEnoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered. | Drug | Conventional Enoxaprin |
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 Feb 2010.
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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 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 High dose Atorvastatin+enoxaparin and Enoxaparin in people with Thrombosis and Prevention, 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 Feb 2010. 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?
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 Feb 2010.