Coronary Artery DiseasePhase 4Rosuzet-IVUSNCT03169985
Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque
A Phase 4 study testing Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day and Rosuvastatin 20 mg orally once a day in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day and Rosuvastatin 20 mg orally once a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2017to 28 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin on Coronary Atherosclerotic Plaque by Intravascular Ultrasound (ROSUZET-IVUS Trial)
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.
Read the detailed description
High-intensity statin therapy have shown improved clinical outcomes compared to placebo or moderate-intensity statin therapy. Based on these results, 2013 American College of Cardiology/American Heart Association(ACC/AHA) guideline on treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults recommended high-intensity statin therapy to patient with coronary artery disease for secondary prevention. However, high-intensity statin therapy was known to increase risk of diabetes mellitus and complication such as hepatotoxicity and myalgia. An alternative to high-intensity statin therapy is reducing the dose of statin and using drug that can improve blood cholesterol level by a different mechanism than statin. Ezetimibe acts on Niemann-Pick C1-like protein then inhibits cholesterol absorption in the intestine, which can reduce low-density lipoprotein(LDL) cholesterol more effectively when administered with statin. In IMPROVE-IT study, simvastatin plus ezetimibe decreased ischemic events more than simvastatin alone in patients with acute coronary syndrome. Although this study could confirm the additional effect of ezetimibe by using the same amount of simvastatin in both groups, it could not compare the effect of statin plus ezetimibe and high dose statin monotherapy. Moreover, there were few data on the efficacy of ezetimibe added to rosuvastatin which is one of the effective statin recommended by various guidelines. One study reported that rosuvastatin 2.5 mg plus ezetimibe 10 mg was superior to rosuvastatin 5 mg monotherapy in reducing LDL cholesterol. Another study reported that adding rosuvastatin 5 mg to ezetimibe 10 mg was more effective than rosuvastatin 5 mg alone in reducing coronary atherosclerotic lesions as measured by intravascular ultrasound. However, the previous studies did not compare the efficacy of combination therapy of usual dose rosuvastatin and ezetimibe to high-dose statin monotherapy. Therefore, investigators aimed to compare the effect of rosuvastatin 10 mg plus ezetimibe 10 mg to rosuvastatin 20 mg alone on the reduction of coronary atherosclerosis in patient with coronary artery disease. If this study shows that the combination of usual dose rosuvastatin and ezetimibe is not inferior to high dose rosuvastatin monotherapy in anti-atherosclerotic effect and safety, it would provide a basis for effective and safe cholesterol treatment.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day, Rosuvastatin 20 mg orally once a day
- Keywords
- Rosuvastatin, Ezetimibe, Atherosclerotic plaque, Intravascular ultrasound
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a dayDrug
Also called Rosuzet tablet 10/10 mg
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 dayDrug
Also called Crestor tablet 20 mg
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 group | Role | What they receive |
|---|---|---|
| Rosuvastatin plus ezetimibe arm | Active comparator | In patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 10 mg plus ezetimibe 10 mg qd during 12 months after randomization. Receives: Drug: Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day |
| High-dose rosuvastatin monotherapy arm | Active comparator | In patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 20 mg qd during 12 months after randomization. Receives: Drug: Rosuvastatin 20 mg orally once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent atheroma volume(PAV) in non-culprit lesions
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
Measured: 12 months after index coronary angiography(CAG)
Secondary outcomes (14)
Change in normalized TAV in non-culprit lesions
The TAV is normalized to the length corresponding to the median number of comparable slices for each treatment group in view of the variability in the length of pullback analyzed between subjects. This value could be expressed as follows:
normalized TAV = [∑(EEM CSA - lumen CSA) / number of images in pullback] X median number of images in cohort
Measured: 12 months after index CAG
Change in indexed TAV
Indexed TAV is calculated as TAV divided by the length of plaque in each subject. This value could be expressed as follows:
Indexed TAV = ∑(EEM CSA - lumen CSA) / plaque length
Measured: 12 months after index CAG
Change in fibrous cap thickness by OCT(optical coherence tomography)
In case that OCT is conducted
Measured: 12 months after index CAG
Change in fractional flow reserve(FFR)
Physiologic index
Measured: 12 months after index CAG
Change in coronary flow reserve(CFR)
Physiologic index
Measured: 12 months after index CAG
Change in index of microcirculatory resistance(IMR)
Physiologic index
Measured: 12 months after index CAG
Change in TAV in coronary computed tomography(CT) angiography
TAV which is measured in CT angiography
Measured: 24 months after index CAG
Major adverse cardiovascular events(MACE)
MACE is defined as a composite of death, myocardial infarction, stroke and revascularization.
Measured: 12, 24 and 36 months after index CAG
Change in homeostatic model assessment(HOMA) index
HOMA index is a method used to quantify insulin resistance. This values could be calculated with fasting plasma glucose and insulin, as follows:
HOMA index = glucose X insulin (mg/dL) / 405
Measured: 6 months after index CAG
Change in fasting glucose
For risk of developing diabetes mellitus by statin therapy
Measured: 6 and 12 months after index CAG
Change in hemoglobin A1c
For risk of developing diabetes mellitus by statin therapy
Measured: 6 and 12 months after index CAG
Change in lipid profile
Fasting plasma triglyceride(TG), high-density lipoprotein(HDL), LDL and total cholesterol. These items will be compared separately, and described as a group of lipid profile.
Measured: 1, 6 and 12 months after index CAG
Change in high-sensitivity C-reactive protein(hs-CRP)
hs-CRP
Measured: 1 and 12 months after index CAG
Safety endpoint: Number of participants with abnormal laboratory values and adverse events
- Creatine kinase(CK) elevation > 10 times upper limit of normal(ULN)
- CK elevation > 10 times ULN on two consecutive visits
- Hepatic transaminases > 3 times ULN
- Hepatic transaminases > 3 times ULN on two consecutive visits
- Document reason for discontinuation of study medication
These items will be described together as a group of safety endpoint, such as number of participants with abnormal laboratory values and adverse events.
Measured: 1 and 12 months after index CAG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start12 Jul 2017
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open label, two-arm, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169985
- Sponsor's protocol ID
- Rosuzet-IVUS16453143
- Acronym
- Rosuzet-IVUS
- Status last verified
- Jul 2025
- First submitted
- 24 May 2017
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin on Coronary Atherosclerotic Plaque by Intravascular Ultrasound (ROSUZET-IVUS Trial)
- ClinicalTrials.gov ID
- NCT03169985
- Acronym / sponsor ID
- Rosuzet-IVUS / Rosuzet-IVUS16453143
- Conditions
- Coronary Artery Disease
- Keywords
- Rosuvastatin, Ezetimibe, Atherosclerotic plaque, Intravascular ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High-intensity statin therapy have shown improved clinical outcomes compared to placebo or moderate-intensity statin therapy. Based on these results, 2013 American College of Cardiology/American Heart Association(ACC/AHA) guideline on treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults recommended high-intensity statin therapy to patient with coronary artery disease for secondary prevention. However, high-intensity statin therapy was known to increase risk of diabetes mellitus and complication such as hepatotoxicity and myalgia. An alternative to high-intensity statin therapy is reducing the dose of statin and using drug that can improve blood cholesterol level by a different mechanism than statin. Ezetimibe acts on Niemann-Pick C1-like protein then inhibits cholesterol absorption in the intestine, which can reduce low-density lipoprotein(LDL) cholesterol more effectively when administered with statin. In IMPROVE-IT study, simvastatin plus ezetimibe decreased ischemic events more than simvastatin alone in patients with acute coronary syndrome. Although this study could confirm the additional effect of ezetimibe by using the same amount of simvastatin in both groups, it could not compare the effect of statin plus ezetimibe and high dose statin monotherapy. Moreover, there were few data on the efficacy of ezetimibe added to rosuvastatin which is one of the effective statin recommended by various guidelines. One study reported that rosuvastatin 2.5 mg plus ezetimibe 10 mg was superior to rosuvastatin 5 mg monotherapy in reducing LDL cholesterol. Another study reported that adding rosuvastatin 5 mg to ezetimibe 10 mg was more effective than rosuvastatin 5 mg alone in reducing coronary atherosclerotic lesions as measured by intravascular ultrasound. However, the previous studies did not compare the efficacy of combination therapy of usual dose rosuvastatin and ezetimibe to high-dose statin monotherapy. Therefore, investigators aimed to compare the effect of rosuvastatin 10 mg plus ezetimibe 10 mg to rosuvastatin 20 mg alone on the reduction of coronary atherosclerosis in patient with coronary artery disease. If this study shows that the combination of usual dose rosuvastatin and ezetimibe is not inferior to high dose rosuvastatin monotherapy in anti-atherosclerotic effect and safety, it would provide a basis for effective and safe cholesterol treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, open label, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin plus ezetimibe arm | Active comparator | Drug: Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a dayIn patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 10 mg plus ezetimibe 10 mg qd during 12 months after randomization. |
| High-dose rosuvastatin monotherapy arm | Active comparator | Drug: Rosuvastatin 20 mg orally once a dayIn patients who have moderate stenosis(30-70%) in coronary artery and deferred to medical treatment by intracoronary physiologic or radiologic test, this arm will be received rosuvastatin 20 mg qd during 12 months after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a dayAlso: Rosuzet tablet 10/10 mgAfter 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. | Drug | Rosuvastatin plus ezetimibe arm |
| Rosuvastatin 20 mg orally once a dayAlso: Crestor tablet 20 mgAfter 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. | Drug | High-dose rosuvastatin monotherapy arm |
Primary outcome
Change in percent atheroma volume(PAV) in non-culprit lesions
Time frame: 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
14 secondary outcomes
Change in normalized TAV in non-culprit lesions
Time frame: 12 months after index CAG
Change in indexed TAV
Time frame: 12 months after index CAG
Change in fibrous cap thickness by OCT(optical coherence tomography)
Time frame: 12 months after index CAG
Change in fractional flow reserve(FFR)
Time frame: 12 months after index CAG
Change in coronary flow reserve(CFR)
Time frame: 12 months after index CAG
Change in index of microcirculatory resistance(IMR)
Time frame: 12 months after index CAG
Change in TAV in coronary computed tomography(CT) angiography
Time frame: 24 months after index CAG
Major adverse cardiovascular events(MACE)
Time frame: 12, 24 and 36 months after index CAG
Change in homeostatic model assessment(HOMA) index
Time frame: 6 months after index CAG
Change in fasting glucose
Time frame: 6 and 12 months after index CAG
Change in hemoglobin A1c
Time frame: 6 and 12 months after index CAG
Change in lipid profile
Time frame: 1, 6 and 12 months after index CAG
Change in high-sensitivity C-reactive protein(hs-CRP)
Time frame: 1 and 12 months after index CAG
Safety endpoint: Number of participants with abnormal laboratory values and adverse events
Time frame: 1 and 12 months after index CAG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Yong Hahn, MD, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day and Rosuvastatin 20 mg orally once a day in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent atheroma volume(PAV) in non-culprit lesions (time frame: 12 months after index coronary angiography(CAG)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.