Moderate-intensity statin versus individualized LDL-C target therapy for people 70 or older 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)
This trial tests whether giving a moderate-intensity statin or using an individualized LDL‑cholesterol target approach (with ezetimibe added if needed) better prevents heart and blood vessel problems in people aged 70 or older with type 2 diabetes who have no prior cardiovascular disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2186 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT07359105 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares moderate-intensity statin monotherapy against individualized LDL‑C target–based therapy, which may include ezetimibe alone or in combination with statin, in adults aged 70 years or older with type 2 diabetes and no prior atherosclerotic cardiovascular disease. Eligible participants are either untreated with LDL‑C ≥100 mg/dL or are on current lipid‑lowering therapy without an LDL‑C limit. Participants receive the assigned approach and are followed for changes in LDL‑C as well as for cardiovascular events and safety outcomes. The study is conducted at major hospitals in Seoul, South Korea.
Who should consider this trial
Good fit: Ideal candidates are adults aged 70 years or older with type 2 diabetes, no history of atherosclerotic cardiovascular disease, and either LDL‑C ≥100 mg/dL if untreated or currently taking lipid‑lowering therapy.
Not a fit: People with type 1 diabetes, a prior history of atherosclerotic cardiovascular disease, active cancer treatment, or other severe comorbid conditions are unlikely to benefit from this trial's interventions.
Why it matters
Potential benefit: If successful, this approach could clarify whether LDL‑lowering treatments safely reduce cardiovascular risk in older adults with type 2 diabetes and inform age‑specific treatment recommendations.
How similar studies have performed: Previous trials have shown clear benefit of intensive LDL‑C lowering for secondary prevention, but evidence for primary prevention in adults aged 70+ with type 2 diabetes is limited and results are inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Adults aged 70 years or older * Diagnosed with type 2 diabetes or currently receiving antidiabetic medication, without a history or presence of cardiovascular disease * 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: * Diagnosis of type 1 diabetes * 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 * Currently undergoing cancer treatment * Severe disease requiring recurrent hospitalization * Frailty (defined as a score ≥3 on the Korean FRAIL questionnaire), or any condition significantly limiting self-care * 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 * Contraindications to study drugs * Pregnant or breastfeeding women
Where this trial is running
Seoul and 1 other locations
- Korea University ANAM Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Sin Gon Kim, MD — Korea University Anam Hospital
- Study coordinator: Kim
- Email: aakmcaaec002@kumc.or.kr
- Phone: 82-2-920-6791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.