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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05361421

Collaborator

(none)

1,200

Enrollment

Location

Arms

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Intensive targeting group Drug: Conventional therapy group	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive targeting group Intensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL	Drug: 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.
Active Comparator: Conventional therapy group Initiate and maintain moderate intensity statin therapy	Drug: 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.

Arm

Intervention/Treatment

Experimental: Intensive targeting group

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

Drug: 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.

Active Comparator: Conventional therapy group

Initiate and maintain moderate intensity statin therapy

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

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
Inability to understand or read the informed content

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05361421

Other Study ID Numbers:

4-2022-0259

First Posted:

May 4, 2022

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of May 4, 2022