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Cardiovascular DiseasePhase 4NCT05361421

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

A Phase 4 study testing Intensive targeting group and Conventional therapy group in people with Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Cardiovascular Disease
What is being tested?
Intensive targeting group and Conventional therapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteSouth Korea
Study dates
19 Jul 2022to 15 Oct 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

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.

Being tested
Intensive targeting group, Conventional therapy group
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive targeting groupDrug

    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 groupDrug

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

Study groups in NCT05361421
Study groupRoleWhat they receive
Intensive targeting groupExperimentalIntensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL
Receives: Drug: Intensive targeting group
Conventional therapy groupActive comparatorInitiate and maintain moderate intensity statin therapy
Receives: Drug: Conventional therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical efficacy of intensive lipid-lowering therapy

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

    Measured: 3 years

Secondary outcomes (21)

  1. Cardiovascular death

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

    Measured: 3 years

  2. Non-fatal MI

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

    Measured: 3 years

  3. Non-fatal stroke

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

    Measured: 3 years

  4. Coronary revascularization

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

    Measured: 3 years

  5. Hospitalization for unstable angina

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

    Measured: 3 years

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

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

    Measured: 3 years

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

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

    Measured: 3 years

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

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

    Measured: 3 years

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

    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

    Measured: 3 years

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

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

    Measured: 3 years

  11. New-onset diabetes mellitus

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

    Measured: 3 years

  12. Worsening of glycemic control

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

    Measured: 3 years

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

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

    Measured: 3 years

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

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

    Measured: 3 years

  15. Elevation of muscle enzymes

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

    Measured: 3 years

  16. Elevation of hepatic enzymes

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

    Measured: 3 years

  17. Elevation of serum creatinine level

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

    Measured: 3 years

  18. Change of proteinuria

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

    Measured: 3 years

  19. Diagnosis of cancer

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

    Measured: 3 years

  20. Operation due to cataract

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

    Measured: 3 years

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

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start19 Jul 2022
  3. Primary completion15 Oct 2027 (estimated)
  4. Study completion15 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05361421
Sponsor's protocol ID
4-2022-0259
Status last verified
May 2026
First submitted
29 Apr 2022
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intensive targeting group and Conventional therapy group in people with Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical efficacy of intensive lipid-lowering therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05361421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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