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

NCT ID: NCT04056169

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2019-07-23

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.

Conditions

Acute Coronary Syndrome; Carotid Atherosclerotic Plaque With Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

rosuvastatin 20 mg once a day for 6 months

Group Type: ACTIVE_COMPARATOR

high-dose rosuvastatin

Intervention Type: DRUG

rosuvastatin 20 mg once a day for 6 months

ezetimibe/rosuvastatin

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

Group Type: EXPERIMENTAL

low-dose rosuvastatin plus ezetimibe

Intervention Type: DRUG

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

Interventions

high-dose rosuvastatin

rosuvastatin 20 mg once a day for 6 months

Intervention Type: DRUG

low-dose rosuvastatin plus ezetimibe

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

seeCAP

Identifier Type: -

Identifier Source: org_study_id