Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The improvement rate of venous insufficiency
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Researchers, research coordinators, and subjects are all blind.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were initially diagnosed with venous thromboembolism
- •Patients who were between 19 and 70 years of age with dyslipidemia (LDL> = 100 mg / dl)
排除标准
- •Active cancer status
- •Known CVD (ischemic heart disease, stroke, peripheral artery disease)
- •LDL> 190ml / dL or LDL <100mg / dL
- •Contraindication for anticoagulation (NOAC)
- •Contraindication for Statin(Pregnancy, Breastfeeding, Active liver disease, Elevation of liver enzymes, Allergic reaction to a statin)
- •Patients with vital sign unstable with Massive VTE
- •DVT remains in the vascular ultrasound
研究组 & 干预措施
Rosuvastatin 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.
干预措施: Rosuvastatin 20mg (Drug)
Control
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.
干预措施: Control (Drug)
结局指标
主要结局
The improvement rate of venous insufficiency
时间窗: 6months
Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)
次要结局
- Comparison of changes in lab data(6months)