NCT07359105

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,186 (estimated)
• Sponsor: Sin Gon Kim · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Moderate-intensity statin monotherapy	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.
DRUG	Ezetimibe or ezetimibe-statin combination therapy	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.

Timeline

• Start date: 2026-03-09
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-01-22
• Last updated: 2026-03-10

Locations

2 sites across 1 country: South Korea