None listed
Conditions
Interventions
Drug : During the treatment period, patients will receive daily doses of study medication per individual treatment arm assignment determined by randomization in a 1:1 allocation ratio within strata to
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women between the ages of 18 and 75 years who have prediabetes -Prediabetes consists of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or HbA1c (a) IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL (b) IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL (c) HbA1c: 5.7 to 6.4% 2. Patient requiring high-intensity statin due to high risk of a future cardiovascular event if at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening (Clinically documented ASCVD) - acute coronary syndrome (MI or unstable angina) - stable angina - coronary revascularization (PCI, CABG, and other arterial revascularization procedure) - stroke or TIA - peripheral arterial disease ( significant plaque on coronary angiography on CT (mild, moderate, severe coronary artery disease) -> significant plaque on carotid ultrasound (mild, moderate, severe carotid disease) 3. Patients who were not given statins (statin naive) or who were no compliance problems. 4. Patient must have been on a stable diet prior to randomization and willing to follow the NCEP (national Cholesterol Education Program) TLC (therapeutic lifestyle changes) diet, or equivalent diet, throughout the study. 5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
Exclusion criteria: 1. Patient’s pregnant or breast-feeding or child-bearing potential. 2. Concomitant administration of potent inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins). 3. Chronic kidney disease (eGFR 3 times upper limit of normal). 15. Life expectancy < 1 years for any non-cardiac or cardiac causes 16. Unwillingness or inability to comply with the procedures described in this protocol. 17. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin (Gestatin M)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New-onset-DM;All cause death | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite cardiovascular safety (death from cardiovasular cause, non fatal myocardial infarction of nom fatal stroke);Any arterial revascularization (carotid, coronary aorta or peripheral artery);Any potential side effect ;Each component of composite cardiovascular endpoint;Each component of the diabetes-mellitus diagnosis criteria;All cause mortality | — |
Countries
Korea, Republic of
Contacts
Public ContactSu-Bin Shin
Asan Medical Center
Outcome results
None listed