4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event

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

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).

  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

Study Design
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
Arms and Interventions
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.
Outcome Measures
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



Eligibility Criteria
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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE September 19, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • The improvement rate of venous insufficiency [ Time Frame: 6months ]
    Venous function test (test items according to research) - DVT doppler(thrombus, spontaneous echo contrasts, compressibility)
  • The improvement rate of venous insufficiency [ Time Frame: 6months ]
    Venous function test (test items according to research) - Venous insufficiency doppler (reflux, reflux site)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Comparison of changes in blood lipid levels, inflammation, and blood coagulation [ Time Frame: 6months ]
    - Test items according to standard treatment WBC, Hemoglobin, BUN, Creatinine, CRP, D-dimer, Fibrinogen, PAI-1
  • Comparison of changes in blood lipid levels, inflammation, and blood coagulation [ Time Frame: 6months ]
    - Test items according to research AST, ALT, CK, total cholesterol, triglyceride, HDL, LDL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
Official Title  ICMJE Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Venous Thromboembolism
  • Dyslipidemias
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rosuvastatin 20mg
  • 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.
    Intervention: Drug: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Geu Ru Hong, MD., PhD. 82-2-2228-8443 GRHONG@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988101
Other Study ID Numbers  ICMJE 4-2018-0726
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯