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

NCT03988101 | Completed Phase 4

• 1 other identifier: 4-2018-0726
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Primary evaluation item: Improvement of venous insufficiency at 6 months
2. 2.Secondary evaluation items: Improvement of blood lipid concentration, inflammation and blood clotting at 6 months Comparison of numerical rate of change
3. 3.Tertiary evaluation items: recurrence of venous thrombosis

Conditions

Venous Thromboembolism; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Comparison of changes in lab data

  6months

• Comparison of changes in lab data

  6months

Study Arms (2)

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.

Drug: Rosuvastatin 20mg

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.

Drug: Control

Interventions

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.

Rosuvastatin 20mg

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.

Control

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who were initially diagnosed with venous thromboembolism
• \. Patients who were between 19 and 70 years of age with dyslipidemia (LDL\> = 100 mg / dl)

You may not qualify if:

• \. Under 18
• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Venous Thromboembolism; Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Researchers, research coordinators, and subjects are all blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective placebo-controlled, double-blind, phase IV clinical study to evaluate the efficacy and safety of statin in patient with venous dysfunction

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 17, 2019
• Study Start: September 19, 2019
• Primary Completion: March 29, 2024
• Study Completion: May 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

KR (1)