Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988101
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Dyslipidemias Drug: Rosuvastatin 20mg Drug: Control Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Researchers, research coordinators, and subjects are all blind.
Primary Purpose: Treatment
Official Title: Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The improvement rate of venous insufficiency [ Time Frame: 6months ]
    Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)

  2. The improvement rate of venous insufficiency [ Time Frame: 6months ]
    Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)


Secondary Outcome Measures :
  1. Comparison of changes in lab data [ Time Frame: 6months ]

    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


  2. Comparison of changes in lab data [ Time Frame: 6months ]

    Comparison of changes in blood lipid levels, inflammation, and blood coagulation

    - Test items according to research AST, ALT, CK, total cholesterol, triglyceride, HDL, LDL




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988101


Contacts
Layout table for location contacts
Contact: Geu Ru Hong, MD., PhD. 82-2-2228-8443 GRHONG@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Geu-Ru Hong, MD, PhD    82-2-2228-8443    GRHONG@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03988101     History of Changes
Other Study ID Numbers: 4-2018-0726
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors