Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2017
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2019
CompletedFirst Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedAugust 16, 2019
August 1, 2019
2.1 years
August 8, 2019
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
6 months
Secondary Outcomes (8)
Change in MDS TBR
6 months
Change in whole vessel TBR within the index vessel
6 months
Change in whole vessel TBR of the aorta
6 months
Change in total cholesterol
6 months
Change in triglyceride
6 months
- +3 more secondary outcomes
Study Arms (2)
Rosuvastatin
ACTIVE COMPARATORrosuvastatin 20 mg once a day for 6 months
ezetimibe/rosuvastatin
EXPERIMENTALezetimibe/rosuvastatin 10/5 mg once a day for 6 months
Interventions
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 14, 2019
Study Start
June 29, 2017
Primary Completion
July 23, 2019
Study Completion
July 23, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08