Venous ThromboembolismPhase 4NCT03988101
Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
A Phase 4 study testing Rosuvastatin 20mg in people with Venous Thromboembolism and Dyslipidemias, run by Yonsei University at 1 site in South Korea.
Trial summary
Participants between the ages of 19 and 70 who were initially diagnosed with venous thromboembolism and were accompanied by dyslipidemia (LDL> = 100 mg / dl) were enrolled. Participants diagnosed with pulmonary embolism, pulmonary embolism CT, and peripheral B-mode ultrasound (B-mode ultrasound) Only participants who… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Venous Thromboembolism, Dyslipidemias
- What is being tested?
- Rosuvastatin 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2019to 30 May 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients who were initially diagnosed with venous thromboembolism
- 2. Patients who were between 19 and 70 years of age with dyslipidemia (LDL> = 100 mg / dl)
Who cannot join
- 1. Under 18
- 2. Active cancer status
- 3. Known CVD (ischemic heart disease, stroke, peripheral artery disease)
- 4. LDL> 190ml / dL or LDL <100mg / dL
- 5. Contraindication for anticoagulation (NOAC)
- 6. Contraindication for Statin(Pregnancy, Breastfeeding, Active liver disease, Elevation of liver enzymes, Allergic reaction to a statin)
- 7. Patients with vital sign unstable with Massive VTE
- 8. DVT remains in the vascular ultrasound
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Participants between the ages of 19 and 70 who were initially diagnosed with venous thromboembolism and were accompanied by dyslipidemia (LDL> = 100 mg / dl) were enrolled.
Participants diagnosed with pulmonary embolism, pulmonary embolism CT, and peripheral B-mode ultrasound (B-mode ultrasound) Only participants who do not meet the exclusion criteria should be enrolled in the study.
Read more
Once the participant is selected, the patient is informed of the study and receives the consent form.
Participants who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. Participants who previously used statins have a wash-out period of two weeks or more Participants undergo a visit at 12 weeks after initiation of treatment. For fasting blood tests, patients visit on an empty stomach. Outpatient follow-up observes side effects after last visit and observes changes in vital signs and weight.
After 24 weeks of treatment, the participant visits for efficacy evaluation. We performed body weight, vital signs and blood tests (WBC, hemoglobin, BUN, creatinine, CRP, D-dimer, fibrinogen, PAI-1, AST, ALT, CK, total cholesterol, triglyceride, HDL and LDL).
- Primary evaluation item: Improvement of venous insufficiency at 6 months
- Secondary evaluation items: Improvement of blood lipid concentration, inflammation and blood clotting at 6 months Comparison of numerical rate of change
- Tertiary evaluation items: recurrence of venous thrombosis
- Conditions
- Venous Thromboembolism, Dyslipidemias
- Being tested
- Rosuvastatin 20mg, Control
- Medical subject headings
- Venous Thromboembolism, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20mgDrug
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent.
ControlDrug
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20mg | Experimental | Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. Receives: Drug: Rosuvastatin 20mg |
| Control | Placebo comparator | Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement rate of venous insufficiency
Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)
Measured: 6months
The improvement rate of venous insufficiency
Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)
Measured: 6months
Secondary outcomes (2)
Comparison of changes in lab data
Comparison of changes in blood lipid levels, inflammation, and blood coagulation
- Test items according to standard treatment WBC, Hemoglobin, BUN, Creatinine, CRP, D-dimer, Fibrinogen, PAI-1
Measured: 6months
Comparison of changes in lab data
Comparison of changes in blood lipid levels, inflammation, and blood coagulation
- Test items according to research AST, ALT, CK, total cholesterol, triglyceride, HDL, LDL
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start19 Sep 2019
- Primary completion29 Mar 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective placebo-controlled, double-blind, phase IV clinical study to evaluate the efficacy and safety of statin in patient with venous dysfunction
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988101
- Sponsor's protocol ID
- 4-2018-0726
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2019
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When you request the material you want, I can consider giving the requested material. If you have any questions, please contact grhong@yuhs.ac
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
- ClinicalTrials.gov ID
- NCT03988101
- Acronym / sponsor ID
- 4-2018-0726
- Conditions
- Venous Thromboembolism, Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 17 Jun 2019 (actual)
- 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.
Participants between the ages of 19 and 70 who were initially diagnosed with venous thromboembolism and were accompanied by dyslipidemia (LDL> = 100 mg / dl) were enrolled.
Participants diagnosed with pulmonary embolism, pulmonary embolism CT, and peripheral B-mode ultrasound (B-mode ultrasound) Only participants who do not meet the exclusion criteria should be enrolled in the study.
Once the participant is selected, the patient is informed of the study and receives the consent form.
Participants who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. Participants who previously used statins have a wash-out period of two weeks or more Participants undergo a visit at 12 weeks after initiation of treatment. For fasting blood tests, patients visit on an empty stomach. Outpatient follow-up observes side effects after last visit and observes changes in vital signs and weight.
After 24 weeks of treatment, the participant visits for efficacy evaluation. We performed body weight, vital signs and blood tests (WBC, hemoglobin, BUN, creatinine, CRP, D-dimer, fibrinogen, PAI-1, AST, ALT, CK, total cholesterol, triglyceride, HDL and LDL).
- Primary evaluation item: Improvement of venous insufficiency at 6 months
- Secondary evaluation items: Improvement of blood lipid concentration, inflammation and blood clotting at 6 months Comparison of numerical rate of change
- Tertiary evaluation items: recurrence of venous thrombosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A prospective placebo-controlled, double-blind, phase IV clinical study to evaluate the efficacy and safety of statin in patient with venous dysfunction
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20mg | Experimental | Drug: Rosuvastatin 20mgPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. |
| Control | Placebo comparator | Drug: ControlPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients who were initially diagnosed with venous thromboembolism
- 2. Patients who were between 19 and 70 years of age with dyslipidemia (LDL> = 100 mg / dl)
Key exclusion criteria (8 listed)
- 1. Under 18
- 2. Active cancer status
- 3. Known CVD (ischemic heart disease, stroke, peripheral artery disease)
- 4. LDL> 190ml / dL or LDL <100mg / dL
- 5. Contraindication for anticoagulation (NOAC)
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 20mgPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. | Drug | Rosuvastatin 20mg |
| ControlPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent. | Drug | Control |
Primary outcome
The improvement rate of venous insufficiency
Time frame: 6months
Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)
The improvement rate of venous insufficiency
Time frame: 6months
Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)
2 secondary outcomes
Comparison of changes in lab data
Time frame: 6months
Comparison of changes in lab data
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided. When you request the material you want, I can consider giving the requested material. If you have any questions, please contact grhong@yuhs.ac
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Venous Thromboembolism and Dyslipidemias, run by Yonsei University 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 8 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: finished, as of the sponsor's last update on 1 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement rate of venous insufficiency (time frame: 6months). The study lists 2 primary outcomes in all. 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 1 Aug 2025.