Clinical trial NCT03988101: Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
Official title: Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Venous Thromboembolism
Dyslipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective placebo-controlled, double-blind, phase IV clinical study to evaluate the efficacy and safety of statin in patient with venous dysfunction
Primary purpose: TREATMENT

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. 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


Eligibility criteria: 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

Primary outcomes:
measure: The improvement rate of venous insufficiency
timeFrame: 6months
measure: The improvement rate of venous insufficiency
timeFrame: 6months
Secondary outcomes:
measure: Comparison of changes in lab data
timeFrame: 6months
measure: Comparison of changes in lab data
timeFrame: 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: