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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,186
- 试验地点
- 2
- 主要终点
- Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Individualized LDL-C target-based therapy arm
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.
干预措施: Ezetimibe or ezetimibe-statin combination therapy (Drug)
Moderate-intensity statin monotherapy arm
Statin monotherapy with approved medications.
干预措施: Moderate-intensity statin monotherapy (Drug)
结局指标
主要结局
Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE)
时间窗: 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.
次要结局
- 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(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)(From baseline up to 36 months)
研究者
Sin Gon Kim
Professior, Department of Endocrinology and metabolism, Korea University Anam Hospital, South Korea
Korea University Anam Hospital