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

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; Venous Thromboembolism
• Intervention / Treatment: Drug: Rosuvastatin 20mg; Drug: Control

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Geu Ru Hong, MD., PhD.; Phone Number: 82-2-2228-8443; Email: GRHONG@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: 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.
PLACEBO_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2019
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Embolism and Thrombosis; Lipid Metabolism Disorders; Dyslipidemias; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 4-2018-0726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No