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

Primary Purpose

Venous Thromboembolism, Dyslipidemias

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin 20mg
Control
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rosuvastatin 20mg

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The improvement rate of venous insufficiency
Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)
The improvement rate of venous insufficiency
Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)

Secondary Outcome Measures

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
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

Full Information

First Posted
June 14, 2019
Last Updated
June 23, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03988101
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
Researchers, research coordinators, and subjects are all blind.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin 20mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
The improvement rate of venous insufficiency
Description
Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)
Time Frame
6months
Title
The improvement rate of venous insufficiency
Description
Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)
Time Frame
6months
Secondary Outcome Measure Information:
Title
Comparison of changes in lab data
Description
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
Time Frame
6months
Title
Comparison of changes in lab data
Description
Comparison of changes in blood lipid levels, inflammation, and blood coagulation - Test items according to research AST, ALT, CK, total cholesterol, triglyceride, HDL, LDL
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geu Ru Hong, MD., PhD.
Phone
82-2-2228-8443
Email
GRHONG@yuhs.ac
Facility Information:
Facility Name
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geu-Ru Hong, MD, PhD
Phone
82-2-2228-8443
Email
GRHONG@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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

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