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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056169
• Other study ID #: seeCAP
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2017
• Est. completion date: July 23, 2019

Study information

• Verified date: August 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Carotid Atherosclerotic Plaque With Inflammation
• Inflammation
• Plaque, Atherosclerotic
• Syndrome

Intervention

Drug:
• high-dose rosuvastatin
rosuvastatin 20 mg once a day for 6 months
• low-dose rosuvastatin plus ezetimibe
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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