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

NCT05361421 | Recruiting Phase 4 DMC

• 1 other identifier: 4-2022-0259
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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 targeting (intensive targeting \[LDL-cholesterol \<55mg/dL\] vs. conventional therapy \[moderate intensity statin therapy\]) in elderly patients with ≥75 years and documented cardiovascular disease.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of intensive lipid-lowering therapy

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

  3 years

Secondary Outcomes (2)

• Efficacy endpoint

  3 years

• Safety endpoint

  3 years

Study Arms (2)

Intensive targeting group

EXPERIMENTAL

Intensive lipid loweroing therapy with LDL-cholesterol goal of \<55mg/dL

Drug: Intensive targeting group

Conventional therapy group

ACTIVE COMPARATOR

Initiate and maintain moderate intensity statin therapy

Drug: Conventional therapy group

Interventions

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.

Intensive targeting group

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.

Conventional therapy group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥75 years
• Documented 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Byeong-Keuk Kim

CONTACT

82-02-2228-8465; KIMBK@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: July 19, 2022
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 15, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

KR (1)