Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event

Study Overview
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Brief Summary
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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

Official Title
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Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event

Conditions
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Venous Thromboembolism, Dyslipidemias

Intervention / Treatment
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* Drug: Rosuvastatin 20mg
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 20mg<br>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. | Drug: Rosuvastatin 20mg<br>* 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.<br>|
| Placebo Comparator: Control<br>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. | Drug: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement rate of venous insufficiency | Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility) | 6months | 
| The improvement rate of venous insufficiency | Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site) | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6months |