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

Phase 4

• Conditions: Venous Thromboembolism; Dyslipidemias
• Interventions: Drug: Control; Drug: Rosuvastatin 20mg

• Registration Number: NCT03988101
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Study Start: 2019-09-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Rosuvastatin 20mg	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.

Primary Outcome Measures

Name	Time	Method
The improvement rate of venous insufficiency	6months	Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)

Secondary Outcome Measures

Name	Time	Method
Comparison of changes in lab data	6months	Comparison of changes in blood lipid levels, inflammation, and blood coagulation; - Test items according to research AST, ALT, CK, total cholesterol, triglyceride, HDL, LDL

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of