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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988101
• Other study ID #: 4-2018-0726
• Status: Recruiting
• Phase: Phase 4
• Start date: September 19, 2019
• Est. completion date: November 2022

Study information

• Verified date: June 2021
• Source: Yonsei University
• Contact: Geu Ru Hong, MD., PhD.
• Phone: 82-2-2228-8443
• Email: GRHONG[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement rate of venous insufficiency	Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)	6months
Primary	The improvement rate of venous insufficiency	Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)	6months
Secondary	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
Secondary	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