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Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high-dose rosuvastatin
low-dose rosuvastatin plus ezetimibe
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography

Eligibility Criteria

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

Inclusion Criteria:

  1. aged ≥ 19 years
  2. acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging
  3. written consent

Exclusion Criteria:

  1. previous history of carotid endarterectomy or stenting
  2. schedule for cardiac or major surgery within the next 6 months
  3. statin or ezetimibe therapy in the past 4 weeks
  4. chronic disease needed to be treated with oral, intravenous, or intraarticular steroid
  5. end-stage renal disease
  6. chronic liver disease
  7. history of cancers within the past 3 years
  8. pregnant, breast-feeding or child-bearing potential
  9. expected life expectancy within 2 years

Sites / Locations

  • Asan Medical Center
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rosuvastatin

ezetimibe/rosuvastatin

Arm Description

rosuvastatin 20 mg once a day for 6 months

ezetimibe/rosuvastatin 10/5 mg once a day for 6 months

Outcomes

Primary Outcome Measures

Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel

Secondary Outcome Measures

Change in MDS TBR
Change in whole vessel TBR within the index vessel
Change in whole vessel TBR of the aorta
Change in total cholesterol
Change in triglyceride
Change in HDL-cholesterol
Change in LDL-cholesterol
Change in high sensitive C-reactive protein

Full Information

First Posted
August 8, 2019
Last Updated
August 13, 2019
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04056169
Brief Title
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
Official Title
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

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

5. Study Description

Brief Summary
Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by >50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation
Keywords
rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
rosuvastatin 20 mg once a day for 6 months
Arm Title
ezetimibe/rosuvastatin
Arm Type
Experimental
Arm Description
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
Intervention Type
Drug
Intervention Name(s)
high-dose rosuvastatin
Intervention Description
rosuvastatin 20 mg once a day for 6 months
Intervention Type
Drug
Intervention Name(s)
low-dose rosuvastatin plus ezetimibe
Intervention Description
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
Primary Outcome Measure Information:
Title
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in MDS TBR
Time Frame
6 months
Title
Change in whole vessel TBR within the index vessel
Time Frame
6 months
Title
Change in whole vessel TBR of the aorta
Time Frame
6 months
Title
Change in total cholesterol
Time Frame
6 months
Title
Change in triglyceride
Time Frame
6 months
Title
Change in HDL-cholesterol
Time Frame
6 months
Title
Change in LDL-cholesterol
Time Frame
6 months
Title
Change in high sensitive C-reactive protein
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged ≥ 19 years acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging written consent Exclusion Criteria: previous history of carotid endarterectomy or stenting schedule for cardiac or major surgery within the next 6 months statin or ezetimibe therapy in the past 4 weeks chronic disease needed to be treated with oral, intravenous, or intraarticular steroid end-stage renal disease chronic liver disease history of cancers within the past 3 years pregnant, breast-feeding or child-bearing potential expected life expectancy within 2 years
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome

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