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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361421
• Other study ID #: 4-2022-0259
• Status: Recruiting
• Phase: Phase 4
• Start date: July 19, 2022
• Est. completion date: October 15, 2027

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Byeong-Keuk Kim
• Phone: 82-02-2228-8465
• Email: KIMBK[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 15, 2027
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Age =75 years

2. 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.

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy endpoint	Each component of primary endpoint; Various composite outcomes A. Composite of cardiovascular death, non-fatal MI, and non-fatal stroke B. Composite of cardiovascular death, non-fatal MI, non-fatal stroke, and coronary revascularization C. Composite of cardiovascular death, non-fatal MI, and coronary revascularization D. Composite of all-cause death, non-fatal MI, non-fatal stroke, coronary revascularization, and hospitalization for angina; Rate of cross-over into the non-allocated therapy regimen (1, 2, and 3 years after enrollment)	3 years
Secondary	Safety endpoint	New-onset diabetes mellitus, worsening of glycemic control, or homeostatic model assessment (HOMA)-index; Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage; Elevation of muscle enzymes (CPK > 4 x UNL); Elevation of hepatic enzymes (AST, ALT, or both = 3 x UNL); Elevation of serum creatinine level (>50% from baseline); Change of proteinuria; Diagnosis of cancer; Operation due to cataract; Major bleeding (BARC 2, 3, or 5)	3 years