Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Hanmi Pharmaceutical Company Limited | INDUSTRY |
| Yuhan Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Statins are the cornerstone of cardiovascular disease (CVD) prevention through the lowering of low-density lipoprotein cholesterol (LDL-C). While the benefits of intensive LDL-C lowering are well-established for secondary prevention, evidence remains insufficient for primary prevention in the elderly-specifically for individuals aged 70 years or older with type 2 diabetes who have no prior history of atherosclerotic cardiovascular events.
Current guidelines generally recommend moderate-intensity statins for this population based on extrapolated data. However, there is a significant evidence gap regarding whether these older adults, who have not yet experienced a cardiovascular event, derive the same risk-benefit ratio from pharmacological intervention as younger or secondary prevention groups. Furthermore, while ezetimibe (alone or in combination) is an effective alternative for patients with established disease, its efficacy as a primary prevention strategy in older diabetic patients has not been rigorously confirmed through randomized controlled trials (RCTs).
Therefore, this study specifically focuses on the primary prevention setting, aiming to determine whether individualized LDL-C target-based therapy is non-inferior to standard moderate-intensity statin therapy in preventing first-time cardiovascular events among older patients with type 2 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-intensity statin monotherapy arm | Active Comparator | Statin monotherapy with approved medications. |
|
| Individualized LDL-C target-based therapy arm | Experimental | The investigator will establish individualized LDL-C targets (<55 mg/dL or <70 mg/dL or <100 mg/dL) by considering each patient's cardiovascular risk, life expectancy, risk of adverse drug reactions, comorbidities, and personal preferences. The decision-making process will be shared with the patient to ensure that individual needs are addressed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-intensity statin monotherapy | Drug | Atorvastatin 10 mg, 20 mg, or 40 mg, or rosuvastatin 5 mg, 10 mg, or 20 mg will be administered for up to 3 years. If the LDL-C is ≥100 mg/dL, the investigator may adjust the statin intensity based on the patient's health status. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE) | Major adverse cardiovascular event (MACE) includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to heart failure, coronary revascularization, or all-cause death. | 0, 3, 12, 24, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the date of randomization to the first hospitalization due to the following events or to the first occurrence of such events, whichever occurs earlier : (1) ischemic heart disease, (2) cerebrovascular disease, (3) heart failure, (4) peripheral | 0, 3, 12, 24, 36 months | |
| Time from the date of randomization to the first occurrence of all-cause hospitalization or all-cause death, whichever occurs first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim | Contact | 82-2-920-6791 | aakmcaaec002@kumc.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sin Gon Kim, MD | Korea University Anam Hospital | Principal Investigator |
| Bong-Soo Cha, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University ANAM Hospital | Recruiting | Seoul | South Korea | |||
| Severance Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Eligible patients will be randomly assigned in a 1:1 ratio at Visit 1, using the Interactive Web Response System (IWRS), to either the moderate-intensity statin monotherapy arm or the individualized LDL-C target-based therapy arm.
Not provided
Not provided
Not provided
Not provided
| Ezetimibe or ezetimibe-statin combination therapy | Drug | Treatment will consist of non-pharmacological interventions or marketed medications, including low-dose statins (atorvastatin 5 mg or 10 mg, rosuvastatin 2.5 mg or 5 mg) in combination with ezetimibe 10 mg, or fixed-dose combinations (rosuvamibe 10/2.5 mg, atorvabmibe 10/5 mg, or Rosuzet 10/2.5 mg), for up to 3 years. If the pre-specified LDL-C target is not achieved or drug intolerance occurs, adjustments in dosage or medication will be made. |
|
| 0, 3, 12, 24, 36 months |
| Serum lipid levels from baseline at each assessment time point | 0, 3, 12, 24, 36 months |
| Serum lipid changes from baseline at each assessment time point | 0, 3, 12, 24, 36 months |
| Patterns of study drug use | From baseline up to 36 months |
| Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events | From baseline up to 36 months |
| Incidence rates and characteristics of adverse events of special interest (AESI) | Adverse events of special interest (AESI): (1) Elevation of aminotransferase levels, (2) Rhabdomyolysis/myopathy, (3) Gastrointestinal problems | From baseline up to 36 months |
| Not yet recruiting |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided