Acute Coronary Syndrome Clinical Trial
Official title:
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
NCT number | NCT04056169 |
Other study ID # | seeCAP |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 29, 2017 |
Est. completion date | July 23, 2019 |
Verified date | August 2019 |
Source | Yuhan Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 23, 2019 |
Est. primary completion date | July 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yuhan Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel | 6 months | ||
Secondary | Change in MDS TBR | 6 months | ||
Secondary | Change in whole vessel TBR within the index vessel | 6 months | ||
Secondary | Change in whole vessel TBR of the aorta | 6 months | ||
Secondary | Change in total cholesterol | 6 months | ||
Secondary | Change in triglyceride | 6 months | ||
Secondary | Change in HDL-cholesterol | 6 months | ||
Secondary | Change in LDL-cholesterol | 6 months | ||
Secondary | Change in high sensitive C-reactive protein | 6 months |
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