Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Treatment
high-intensity statin arm
low-intensity statin plus ezetimibe
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men or women between the ages of 18 and 75 years who have prediabetes
- Prediabetes consists of impaired fasting glucose (IFG) or impaired glucosetolerance (IGT) or HbA1c
IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL
IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL
HbA1c: 5.7 to 6.4%
Patient requiring high-intensity statin due to high risk of a future cardiovascularevent if at least one of the following criteria is present via patient history,physical examination, or medical records at the time of screening (Clinicallydocumented ASCVD)
acute coronary syndrome (MI or unstable angina)
stable angina
coronary revascularization (PCI, CABG, and other arterial revascularizationprocedure)
stroke or TIA
peripheral arterial disease (<0.9 performed by a vascular lab or angiogram (including CTA) showing ≥ 50%)
ThoracoAbdominal Aortic Aneurysm
Unequivocally documented ASCVD on imaging
significant plaque on coronary angiography on CT (mild, moderate, severecoronary artery disease)
significant plaque on carotid ultrasound (mild, moderate, severe carotiddisease)
Patients who have never taken a statin or who do not have problems adhering tostatin therapy
Patient must have been on a stable diet prior to randomization and willing to followthe NCEP (national Cholesterol Education Program) TLC (therapeutic lifestylechanges) diet, or equivalent diet, throughout the study.
The patient or guardian agrees to the study protocol and the schedule of clinicalfollow-up, and provides informed, written consent, as approved by the appropriateInstitutional Review Board/Ethical Committee of the respective clinical site.
Exclusion
Exclusion Criteria:
Patient's pregnant or breast-feeding or child-bearing potential.
Concomitant administration of potent inhibitors of CYP3A4 (itraconazole,ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin andnefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).
Chronic kidney disease (eGFR<30 ml/min/1.73m2) or dialysis-dependent renal failure
Uncontrolled hypothyroidism.
Personal or family history of hereditary muscular disorders.
History of muscular toxicity with a statin
Alcoholism.
Hypersensitivity to any of statin and ezetimibe.
Hemodynamic unstable conditions at the time of inclusion: cardiogenic shock at thetime of randomization, refractory ventricular arrhythmias, or congestive heartfailure (New York Heart Association class IV).
Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6months
Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6months after randomization
A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) inthe past 3 years or current treatment for the active cancer.
Any clinically significant abnormality identified at the screening visit, physicalexamination, laboratory tests, or electrocardiogram which, in the judgment of theInvestigator, would preclude safe completion of the study.
Hepatic disease or biliary tract obstruction, or significant hepatic enzymeelevation (ALT or AST > 3 times upper limit of normal) or (Total bilirubin> 2 timesupper limit of normal).
Life expectancy < 1 years for any non-cardiac or cardiac causes
Unwillingness or inability to comply with the procedures described in this protocol.
People who have previously been diagnosed with diabetes and are taking lifestylemodification and oral hypoglycemic agent (OHA) or insulin (In woman, gestationaldiabetes is included)
Study Design
Study Description
Connect with a study center
Bycheon Sejong Hospital
Bucheon,
Korea, Republic ofActive - Recruiting
Gyeongsang National University Changwon Hospital
Changwon,
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital
Cheonju,
Korea, Republic ofActive - Recruiting
Gangwon National University Hospital
Chuncheon,
Korea, Republic ofActive - Recruiting
Daegu Catholic University Medical Center
Daegu,
Korea, Republic ofActive - Recruiting
Keimyung University Dongsan Medical Center
Daegu,
Korea, Republic ofActive - Recruiting
Yungnam universury Hospital
Daegu,
Korea, Republic ofSite Not Available
Chungnam National University Sejong Hospital
Daejeon,
Korea, Republic ofActive - Recruiting
Konyang University Hospital
Daejeon,
Korea, Republic ofActive - Recruiting
Gangneung Asan Hospital
Gangneung,
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon,
Korea, Republic ofSite Not Available
Jeju National University Hospital
Jeju,
Korea, Republic ofSite Not Available
Gyeongsang National University Hospital
Jinju,
Korea, Republic ofActive - Recruiting
Dong-A Medical Center
Pusan,
Korea, Republic ofActive - Recruiting
Inje University Busan Paik Hospital
Pusan,
Korea, Republic ofActive - Recruiting
Kosin University Gospel Hospital
Pusan,
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Pusan,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Ewha womans university seoul hospital
Seoul,
Korea, Republic ofSite Not Available
Hallym University Medical Center-Kangdong
Seoul,
Korea, Republic ofSite Not Available
Kangdong Sacred Heart Hospital
Seoul,
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul,
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon,
Korea, Republic ofSite Not Available
The Catholic University of Korea, St. Vincent's Hospital
Suwon,
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan,
Korea, Republic ofSite Not Available
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