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NCT Number: NCT05361421

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥75 years
  • 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

  • MI or stroke within 1 year
  • LDL-cholesterol level less than 55 mg/dL without statin therapy
  • Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
  • Allergy or hypersensitivity to any statin
  • Life expectancy less than 1 years
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Treatment and study plan

Intensive targeting group

Drug

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

Drug

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

Primary outcomes

  1. Clinical efficacy of intensive lipid-lowering therapy

    Time frame: 3 years

    Primary Outcome - Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for unstable angina

Secondary outcomes

  1. Cardiovascular death

    Time frame: 3 years

    Occurrence of cardiovascular death during the 3-year follow-up period

  2. Non-fatal MI

    Time frame: 3 years

    Occurrence of non-fatal MI during the 3-year follow-up period

  3. Non-fatal stroke

    Time frame: 3 years

    Occurrence of non-fatal stroke during the 3-year follow-up period

  4. Coronary revascularization

    Time frame: 3 years

    Occurrence of coronary revascularization during the 3-year follow-up period

  5. Hospitalization for unstable angina

    Time frame: 3 years

    Occurrence of hospitalization for unstable angina during the 3-year follow-up period

  6. Composite of cardiovascular death, non-fatal MI, and non-fatal stroke

    Time frame: 3 years

    First occurrence of cardiovascular death, non-fatal MI, or non-fatal stroke during the 3-year follow-up period

  7. Composite of cardiovascular death, non-fatal MI, non-fatal stroke, and coronary revascularization

    Time frame: 3 years

    First occurrence of cardiovascular death, non-fatal MI, non-fatal stroke, or coronary revascularization during the 3-year follow-up period

  8. Composite of cardiovascular death, non-fatal MI, and coronary revascularization

    Time frame: 3 years

    First occurrence of cardiovascular death, non-fatal MI, or coronary revascularization during the 3-year follow-up period

  9. Composite of all-cause death, non-fatal MI, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina

    Time frame: 3 years

    First occurrence of all-cause death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina during the 3-year follow-up period

  10. Rate of cross-over into the non-allocated therapy strategy

    Time frame: 3 years

    Rate of cross-over into the non-allocated therapy strategy at 1 month, and 1, 2, and 3 years after enrollment

  11. New-onset diabetes mellitus

    Time frame: 3 years

    Occurrence of new-onset diabetes mellitus during the 3-year follow-up period

  12. Worsening of glycemic control

    Time frame: 3 years

    Occurrence of worsening of glycemic control during the 3-year follow-up period

  13. Change of homeostasis model assessment of insulin resistance (HOMA-IR) index

    Time frame: 3 years

    Change in HOMA-IR index from baseline at 1, 2, and 3 years after enrollment

  14. Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage

    Time frame: 3 years

    Occurrence of SAMS requiring change of therapy regimen or dosage during the 3-year follow-up period

  15. Elevation of muscle enzymes

    Time frame: 3 years

    Occurrence of elevation of muscle enzymes (CPK level > 4 x UNL) during the 3-year follow-up period

  16. Elevation of hepatic enzymes

    Time frame: 3 years

    Occurrence of elevation of hepatic enzymes (AST, ALT, or both levels ≥ 3 x UNL) during the 3-year follow-up period

  17. Elevation of serum creatinine level

    Time frame: 3 years

    Occurrence of elevation of serum creatinine level (>50% increase from baseline) during the 3-year follow-up period

  18. Change of proteinuria

    Time frame: 3 years

    Change in proteinuria assessed by urinalysis from baseline at 1, 2, and 3 years after enrollment

  19. Diagnosis of cancer

    Time frame: 3 years

    Occurrence of diagnosis of cancer during the 3-year follow-up period

  20. Operation due to cataract

    Time frame: 3 years

    Occurrence of operation due to cataract during the 3-year follow-up period

  21. Major bleeding (BARC 2, 3, or 5)

    Time frame: 3 years

    Occurrence of major bleeding (BARC 2, 3, or 5) during the 3-year follow-up period

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 4, 2022
Registry last updated
May 29, 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.

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