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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20mg | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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A prospective placebo-controlled, double-blind, phase IV clinical study to evaluate the efficacy and safety of statin in patient with venous dysfunction
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Researchers, research coordinators, and subjects are all blind.
| Control | Drug | 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. |
|
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 |
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |