Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07359105

Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University ANAM Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE)

    Time frame: 0, 3, 12, 24, 36 months

    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.

Secondary outcomes

  1. 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

    Time frame: 0, 3, 12, 24, 36 months

  2. Time from the date of randomization to the first occurrence of all-cause hospitalization or all-cause death, whichever occurs first

    Time frame: 0, 3, 12, 24, 36 months

  3. Serum lipid levels from baseline at each assessment time point

    Time frame: 0, 3, 12, 24, 36 months

  4. Serum lipid changes from baseline at each assessment time point

    Time frame: 0, 3, 12, 24, 36 months

  5. Patterns of study drug use

    Time frame: From baseline up to 36 months

  6. Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events

    Time frame: From baseline up to 36 months

  7. Incidence rates and characteristics of adverse events of special interest (AESI)

    Time frame: From baseline up to 36 months

    Adverse events of special interest (AESI): (1) Elevation of aminotransferase levels, (2) Rhabdomyolysis/myopathy, (3) Gastrointestinal problems

Study contacts

Contact information is provided by the study sponsor or research team.

Kim

CONTACT

[email protected]

82-2-920-6791

Sponsors and collaborators

Lead sponsor

Sin Gon Kim

Other

Collaborators

  • Hanmi Pharmaceutical Company Limited
  • Severance Hospital
  • Yuhan Corporation

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.