None listed
Conditions
Interventions
Drug : During the study period, participants will be randomly assigned in a 1:1 ratio to one of two treatment groups and will take the assigned medication for 36 months as follows:
1) High-Intensity
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older. 2. Patients not taking oral hypoglycemic agents (OHA) and meeting all of the following conditions: A. Fasting glucose less than 126 mg/dL.* B. HbA1c less than 6.5%. C. Plasma glucose less than 200 mg/dL two hours after a 75 g oral glucose tolerance test (OGTT). *For fasting glucose, a diagnosis of diabetes mellitus requires two measurements of fasting glucose =126 mg/dL within three months. 3. Patients with established atherosclerotic cardiovascular disease (ASCVD): * Established ASCVD is defined as having at least one of the following (A, B, or C): A. Coronary heart disease (CHD), defined by at least one of the following: (a) Documented history of myocardial infarction (MI). (b) History of coronary revascularization. (c) =50% stenosis in major epicardial coronary arteries confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography. B. Cerebrovascular disease, defined by at least one of the following: (a) Documented history of atherosclerotic stroke. (b) History of carotid revascularization. (c) =50% stenosis in carotid arteries confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound. C. Symptomatic peripheral arterial disease (PAD), defined by at least one of the following: (a) Intermittent claudication with an ankle-brachial index (ABI) =0.90 at rest. (b) =50% stenosis in peripheral arteries (excluding carotid arteries) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound in patients with intermittent claudication. (c) History of peripheral artery revascularization (excluding carotid arteries). (d) Amputation of the ankle or above due to atherosclerotic disease (excluding trauma or osteomyelitis). 4. Patients adhering to a stable dietary regimen prior to randomization and capable of maintaining the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet or an equivalent diet throughout the study. 5. Patients or their legal representatives who agree to the study protocol and clinical follow-up schedule and provide written informed consent approved by the Institutional Review Board/Ethics Committee at the study site.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding, or women of childbearing potential. 2. Requirement for concurrent use of the following: 3. Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) CYP2C9 inhibitors (relative contraindication for non-CYP450-dependent statins). 4. Chronic kidney disease with an estimated glomerular filtration rate (eGFR) 3 times the upper limit of normal) or elevated total bilirubin (>2 times the upper limit of normal) at screening. 16. Life expectancy of less than 1 year due to non-cardiac or cardiac causes. 17. Inability or unwillingness to comply with the study procedures described in this protocol. 18. Individuals previously diagnosed with diabetes who are currently undergoing lifestyle modifications and taking oral hypoglycemic agents (OHA) or insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New onset diabetes mellitus | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite Cardiovascular Safety Assessment (Cardiac Death, Nonfatal Myocardial Infarction, or Nonfatal Stroke);All Arterial Revascularizations (Carotid, Coronary, Aortic, or Peripheral Arteries);Individual Components Constituting the Composite of Major Cardiovascular Clinical Events;All cause death;Criteria for Diabetes Diagnosis;HOMA-Insulin Resistance;Potential Side Effects of Statins;Medication Adherence;LDL Cholesterol Changes During the Follow-Up Period;HbA1c Changes During the Follow-Up Period;Fasting glucose, Insulin Changes During the Follow-Up Period | — |
Countries
Korea, Republic of
Contacts
Public ContactEunHye Joung
Korea University Anam Hospital
Outcome results
None listed