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Completed

NCT Number: NCT04056169

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Carotid Atherosclerotic Plaque With Inflammation Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

high-dose rosuvastatin

Drug

rosuvastatin 20 mg once a day for 6 months

low-dose rosuvastatin plus ezetimibe

Drug

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

Primary outcomes

  1. Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel

    Time frame: 6 months

Secondary outcomes

  1. Change in MDS TBR

    Time frame: 6 months

  2. Change in whole vessel TBR within the index vessel

    Time frame: 6 months

  3. Change in whole vessel TBR of the aorta

    Time frame: 6 months

  4. Change in total cholesterol

    Time frame: 6 months

  5. Change in triglyceride

    Time frame: 6 months

  6. Change in HDL-cholesterol

    Time frame: 6 months

  7. Change in LDL-cholesterol

    Time frame: 6 months

  8. Change in high sensitive C-reactive protein

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2019
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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