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Active, not recruiting Phase 4

Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque

NCT03169985 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2017-07-12
Last updated
2025-07-16

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a dayAll Rosuvastatin trials (36) →All Ezetimibe trials (15) →Rosuvastatin 20 mg orally once a day →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subject must be at least 19 years of age * Subject with suspected ischemic heart disease undergoing coronary angiography and have intermediate coronary artery stenosis (30-70% by visual estimation) whose revascularization was deferred based on invasive physiologic assessment using fractional flow reserve (\>0.80) or intravascular ultrasound (minimum lumen area\> 4mm2) * Subject can verbally confirm understandings of risks, benefits and treatment alternatives of receiving statin or ezetimibe and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: * Subject has calculated creatinine clearance \<30 mL/min or dialysis within 30 days. * Subject has active liver disease or persistent unexplained serum transaminase elevations (x2 x upper limit of normal \[ULN\]). * Subject requires the following concomitant medications: cyclosporine, danazol, niacin, fibrates as concomitant medications * Subject requires any of the potent CYP3A4 inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, and telithromycin, HIV protease inhibitors, nefazodone, probucol, resins, and any investigational drugs. * Subject has an allergy/sensitivity to any statin, ezetimibe, and/or their excipients. * Subject with history of myopathy or family history of myopathy * Untreated hypothyroidism * Subject has a history of alcohol and/or drug abuse. * Subject is a pregnant or lactating woman, or woman intending to become pregnant. * Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment). * Unwillingness or inability to comply with the procedures described in this protocol. * Eligible patients will be randomly assigned to treatment arms, stratified by diagnosis on admission(acute coronary syndrome or stable ischemic heart disease) and presence of chronic statin use (more than one month)

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)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea
Official registry record

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