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Clinical Trials in South Korea / NCT05361421
Active, not recruiting Phase 4

Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial

NCT05361421 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Phase 4
Started
2022-07-19
Last updated
2026-05-29

Condition(s) studied

Cardiovascular Disease

Investigational drug(s) / intervention(s)

Intensive targeting groupConventional therapy group

Intensive targeting group: Intensive lipid lowering therapy with LDL-cholesterol goal of \<55mg/dL. Atorvastatin 5, 10, 20, 40, and 80mg are allowed to use and ezetimibe or PCSK-9 inhibitor may be considered in patients who could not achieve target LDL-cholesterol level even with the maximum dose of study drugs (atorvastatin 80mg) by the discretion of the investigator.

Conventional therapy group: Only moderate intensity statin therapy (atorvastatin 5, 10, and 20mg ) are allowed. Ezetimibe or PCSK-9 inhibitor is not allowed to use.

Study summary

Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy strategy (intensive targeting \[LDL-cholesterol goal of \<55mg/dL\] vs. conventional therapy \[moderate intensity statin therapy\]) in elderly patients with ≥75 years and documented cardiovascular disease.

Eligibility

Sex
ALL
Min age
75 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1. Age ≥75 years 2. Documented atherosclerotic cardiovascular disease (at least 1 of the following) A. Previous acute coronary syndrome (MI or unstable angina) B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia C. Or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) D. Or peripheral artery disease. Exclusion criteria 1. MI or stroke within 1 year 2. LDL-cholesterol level less than 55 mg/dL without statin therapy 3. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range 4. Allergy or hypersensitivity to any statin 5. Life expectancy less than 1 years 6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Primary outcome measure(s)

  • Clinical efficacy of intensive lipid-lowering therapy — 3 years
    Primary Outcome - Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for unstable angina

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05361421 on ClinicalTrials.gov ↗ ← All trials in South Korea