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

RecruitingNAAges 70 Years - anyAllSin Gon Kim
NCT07359105 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patient

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📋 Eligibility rules (as published)
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
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What it tests

  • Moderate-intensity statin monotherapy
  • Ezetimibe or ezetimibe-statin combination therapy
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Where

2 sites
Korea University ANAM Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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