Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque
Condition(s) studied
Investigational drug(s) / intervention(s)
Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day: After the initial 12 months, randomized intervention will be stopped and then this arm will be received either usual dose rosuvastatin plus ezetimibe or high-dose rosuvastatin during the next 24 months by clinical judgement.
Rosuvastatin 20 mg orally once a day: After the initial 12 months, randomized intervention will be stopped and then this arm will be received either usual dose rosuvastatin plus ezetimibe or high-dose rosuvastatin during the next 24 months based by clinical judgement.
Study summary
The aim of this prospective, open-label, randomized, single center study is to compare the effect of usual dose rosuvastatin plus ezetimibe and high-dose rosuvastatin on modifying atherosclerotic plaque.
Eligibility
Primary outcome measure(s)
- Change in percent atheroma volume(PAV) in non-culprit lesions — 12 months after index coronary angiography(CAG)
PAV is calculated as the percentage of the sum of external elastic membrane(EEM) cross sectional areas(CSA) occupied by total atheroma volume(TAV). TAV was determined by summation of the plaque area, defined as the difference between EEM and lumen CSA, for all evaluable images. These values could be expressed as follows: TAV = ∑(EEM CSA - lumen CSA), PAV = 100 X ∑(EEM CSA - lumen CSA) / ∑EEM CSA
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
More Samsung Medical Center trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03169985 on ClinicalTrials.gov ↗ ← All trials in South Korea