- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169985
Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (Rosuzet-IVUS)
The Effect of Usual Dose Rosuvastatin Plue Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Joo Myung Lee, MD, PhD
- Phone Number: 82-2-3410-1246
- Email: Drone80@hanmail.net
Study Contact Backup
- Name: Joo-Yong Hahn, MD, PhD
- Phone Number: 82-2-3410-6653
- Email: ichjy1@gmail.com
Study Locations
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
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Contact:
- Joo Myung Lee, MD, MPH
- Phone Number: 82-2-3410-1246
- Email: drone80@hanmail.net
-
Contact:
- Joo-Yong Hahn, MD, PhD
- Phone Number: 82-2-3410-6653
- Email: ichjy1@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Among patients who undergo CAG for suspected ischemic heart disease and meet all of the followings:
- Moderate stenosis (30-70%) in coronary artery
- Deferred to medical treatment based on physiologic (FFR, CFR, IMR) or radiologic (IVUS with or without OCT) evaluation.
- Agreement obtained by participant
Exclusion Criteria:
- Severe renal failure(glomerular filtration rate < 30 ml/min/1.73m2, hemodialysis or peritoneal dialysis)
- Active liver disease
- Patient taking Niacin or fibrate(if possible, patient can be enrolled to the study after stopping those medication)
- Medical or family history of myositis, unexplained CK elevation > 3 times ULN at first visit
- Life expectancy < 2 years (judged by investigator)
- Coadministration of cyclosporine
- Untreated hypothyroidism
- Patient with poor compliance including alcohol abuse
- History of hypersensitivity including myotoxicity for either statin or ezetimibe
- Pregnant or breast-feeding woman
Other conditions inappropriate for enrollment by investigator
- * 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rosuvastatin plus ezetimibe arm
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.
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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.
Other Names:
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Active Comparator: High-dose rosuvastatin monotherapy arm
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
12 months after index coronary angiography(CAG)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in normalized TAV in non-culprit lesions
Time Frame: 12 months after index CAG
|
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 |
12 months after index CAG
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Change in indexed TAV
Time Frame: 12 months after index CAG
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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 |
12 months after index CAG
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Change in fibrous cap thickness by OCT(optical coherence tomography)
Time Frame: 12 months after index CAG
|
In case that OCT is conducted
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12 months after index CAG
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Change in fractional flow reserve(FFR)
Time Frame: 12 months after index CAG
|
Physiologic index
|
12 months after index CAG
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Change in coronary flow reserve(CFR)
Time Frame: 12 months after index CAG
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Physiologic index
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12 months after index CAG
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Change in index of microcirculatory resistance(IMR)
Time Frame: 12 months after index CAG
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Physiologic index
|
12 months after index CAG
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Change in TAV in coronary computed tomography(CT) angiography
Time Frame: 24 months after index CAG
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TAV which is measured in CT angiography
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24 months after index CAG
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Major adverse cardiovascular events(MACE)
Time Frame: 12, 24 and 36 months after index CAG
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MACE is defined as a composite of death, myocardial infarction, stroke and revascularization.
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12, 24 and 36 months after index CAG
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Change in homeostatic model assessment(HOMA) index
Time Frame: 6 months after index CAG
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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 |
6 months after index CAG
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Change in fasting glucose
Time Frame: 6 and 12 months after index CAG
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For risk of developing diabetes mellitus by statin therapy
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6 and 12 months after index CAG
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Change in hemoglobin A1c
Time Frame: 6 and 12 months after index CAG
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For risk of developing diabetes mellitus by statin therapy
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6 and 12 months after index CAG
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Change in lipid profile
Time Frame: 1, 6 and 12 months after index CAG
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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.
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1, 6 and 12 months after index CAG
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Change in high-sensitivity C-reactive protein(hs-CRP)
Time Frame: 1 and 12 months after index CAG
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hs-CRP
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1 and 12 months after index CAG
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Safety endpoint: Number of participants with abnormal laboratory values and adverse events
Time Frame: 1 and 12 months after index CAG
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These items will be described together as a group of safety endpoint, such as number of participants with abnormal laboratory values and adverse events. |
1 and 12 months after index CAG
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Joo-Yong Hahn, MD, PhD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Coronary Disease
- Coronary Artery Disease
- Plaque, Atherosclerotic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Ezetimibe
Other Study ID Numbers
- Rosuzet-IVUS16453143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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