- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04080310
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial
This study is a multicenter, randomized, open-label, parallel, phase IV trial.
The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.
Study Overview
Status
Conditions
Detailed Description
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 06511
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 19 and 75 years
Presence of atherosclerotic cardiovascular disease Coronary artery disease
- History of acute coronary syndrome
- Stable or unstable angina
- History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
- Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
- Patients who gave informed consent
Exclusion Criteria:
- Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
- A serum triglyceride on fasting >400 mg/dL
- A history of muscular symptoms or rhabdomyolysis due to the use of statin
- Hypersensitivity to rosuvastatin or ezetimibe
- Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
- Enrollment of other clinical trials within 30 days
- Any other issues that the treating physician assumes ineligible for participation in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: combination therapy group
The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
|
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy. After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily. |
Other: intensive statin group
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
|
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy. After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% change of low-density lipoprotein cholesterol
Time Frame: at 12 weeks
|
%change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline * 100
|
at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% change of serum cholesterol level
Time Frame: at 12 and 24 weeks
|
total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL)
|
at 12 and 24 weeks
|
% change of high-sensitivity C-reactive protein
Time Frame: at 12 and 24 weeks
|
hs-CRP(mg/dL)
|
at 12 and 24 weeks
|
% change of fasting glucose
Time Frame: at 12 and 24 weeks
|
fasting plasma glucose(mg/dL)
|
at 12 and 24 weeks
|
% change of homeostatic model assessment for insulin resistance(HOMA-IR)
Time Frame: at 12 and 24 weeks
|
HOMA-IR = glucose * insulin / 405(glucose mg/dL , insulin uIU/mL)
|
at 12 and 24 weeks
|
proportion of participant with statin-associated muscle symptoms
Time Frame: at 12 and 24 weeks
|
occurrence of statin-associated muscle symptoms
|
at 12 and 24 weeks
|
proportion of participant with creatinine phosphokinase elevation
Time Frame: at 12 and 24 weeks
|
proportion of CPK elevation ≥4 or ≥10 upper normal of limit
|
at 12 and 24 weeks
|
proportion of participant with liver function test abnormality
Time Frame: at 12 and 24 weeks
|
proportion of AST/ALT elevation ≥4 or ≥10 upper normal of limit
|
at 12 and 24 weeks
|
proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)
Time Frame: at 12 and 24 weeks
|
MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke
|
at 12 and 24 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- YMC033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinActive, not recruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
Clinical Trials on Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
-
Yonsei UniversityRecruitingCoronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES ImplantationKorea, Republic of
-
Seung-Whan Lee, M.D., Ph.D.Yuhan CorporationRecruitingPre Diabetes | ASCVDKorea, Republic of
-
Samsung Medical CenterNot yet recruitingMetabolic Syndrome | Dyslipidemias | Coronary Artery Calcification
-
Yonsei UniversityNot yet recruitingHealthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular DiseaseKorea, Republic of
-
AkrikhinRussian National Atherosclerosis SocietyCompletedCardiovascular Diseases | Lipid Metabolism DisordersRussian Federation
-
Yonsei UniversityRecruitingAtherosclerotic Cardiovascular DiseaseKorea, Republic of
-
Nanjing First Hospital, Nanjing Medical UniversityNational Natural Science Foundation of China; Nanjing Medical UniversityRecruitingHyperlipidemias | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Cardiovascular EventsChina
-
Stanford UniversityNot yet recruitingChronic Pain | Sedentary TimeUnited States
-
Wake Forest University Health SciencesCompletedLipid DisorderUnited States
-
Shiraz University of Medical SciencesCompleted