NCT03988101

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Venous Thromboembolism
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2019-09-19
• Primary completion: 2024-03-29
• Completion: 2025-05-30
• First posted: 2019-06-17
• Last updated: 2025-08-01

Locations

1 site across 1 country: South Korea