Dyslipidemias, Venous Thromboembolism
Conditions
Brief 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 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). 1. Primary evaluation item: Improvement of venous insufficiency at 6 months 2. Secondary evaluation items: Improvement of blood lipid concentration, inflammation and blood clotting at 6 months Comparison of numerical rate of change 3. Tertiary evaluation items: recurrence of venous thrombosis
Interventions
DRUGRosuvastatin 20mg
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.
DRUGControl
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Researchers, research coordinators, and subjects are all blind.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement rate of venous insufficiency | 6months | Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of changes in lab data | 6months | 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 |
Countries
South Korea
Outcome results
None listed