Registry-based randomized clinical trial of moderate-intensity statin vs. individualized cholesterol therapy in older adults with type 2 diabetes

A registry-based randomized controlled trial of moderate-intensity statin therapy vs. individualized low-density lipoprotein cholesterol target-based therapy for primary prevention of cardiovascular events in patients 70 years of age or older with type 2 diabetes (iTARGET-Elderly Study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011131

Enrollment

2186

Registered

2025-11-11

Start date

2026-03-09

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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 individua

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Provision of written informed consent to participate in the study by the patient or his/her legally authorized representative after receiving and understanding a detailed explanation of the study 2) Adults aged 70 years or older 3) Diagnosed with type 2 diabetes or currently receiving antidiabetic medication, without a history or presence of cardiovascular disease 4) Either: (1) LDL-C=100 mg/dL if not receiving lipid-lowering therapy, or (2) currently receiving lipid-lowering therapy (in this case, LDL-C level not restricted)

Exclusion criteria

Exclusion criteria: 1) Diagnosis of type 1 diabetes 2) Documented history of atherosclerotic cardiovascular disease at screening, confirmed clinically or by imaging: (1) myocardial infarction; (2) coronary revascularization; (3) currently receiving treatment for acute coronary syndrome; (4) history of ischemic stroke; (5) aortic aneurysm; (6) peripheral arterial disease 3) Currently undergoing cancer treatment 4) Severe disease requiring recurrent hospitalization 5) Frailty (defined as a score =3 on the Korean FRAIL questionnaire), or any condition significantly limiting self-care 6) AST or ALT >3 × ULN, at screening (however, patients will be eligible if repeat testing at the time of randomization shows levels <3 × ULN), or liver cirrhosis 7) Contraindications to study drugs 8) Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE) (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to heart failure, coronary revascularization), or all-cause death	—

Secondary

Measure	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 arterial disease, (5) renal event;Time from the date of randomization to the first occurrence of all-cause hospitalization or all-cause death, whichever occurs first;Serum lipid levels and changes from baseline at each assessment time point;Patterns of study drug use;Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events;Incidence rates and characteristics of adverse events of special interest (AESI): (1) Elevation of aminotransferase levels, (2) Rhabdomyolysis/myopathy, (3) Gastrointestinal problems	—

Measure

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 arterial disease, (5) renal event;Time from the date of randomization to the first occurrence of all-cause hospitalization or all-cause death, whichever occurs first;Serum lipid levels and changes from baseline at each assessment time point;Patterns of study drug use;Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events;Incidence rates and characteristics of adverse events of special interest (AESI): (1) Elevation of aminotransferase levels, (2) Rhabdomyolysis/myopathy, (3) Gastrointestinal problems

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Countries

Korea, Republic of

Contacts

Public ContactKyoungShin Kim

Korea University Anam Hospital

aakmcaaec002@kumc.or.kr+82-2-920-6791

Outcome results