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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome; Carotid Atherosclerotic Plaque With Inflammation
• Interventions: Drug: high-dose rosuvastatin; Drug: low-dose rosuvastatin plus ezetimibe

• Registration Number: NCT04056169
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Status Verified: 2019-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	high-dose rosuvastatin	rosuvastatin 20 mg once a day for 6 months
ezetimibe/rosuvastatin	low-dose rosuvastatin plus ezetimibe	ezetimibe/rosuvastatin 10/5 mg once a day for 6 months

Primary Outcome Measures

Name	Time	Method
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel	6 months

Secondary Outcome Measures

Name	Time	Method
Change in whole vessel TBR within the index vessel	6 months
Change in LDL-cholesterol	6 months
Change in total cholesterol	6 months
Change in high sensitive C-reactive protein	6 months
Change in triglyceride	6 months
Change in HDL-cholesterol	6 months
Change in MDS TBR	6 months
Change in whole vessel TBR of the aorta	6 months

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of