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Completed

NCT Number: NCT03988101

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

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

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The improvement rate of venous insufficiency

    Time frame: 6months

    Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)

  2. The improvement rate of venous insufficiency

    Time frame: 6months

    Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)

Secondary outcomes

  1. Comparison of changes in lab data

    Time frame: 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
  2. Comparison of changes in lab data

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jun 17, 2019
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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