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

Phase 4

Recruiting

• Conditions: Cardiovascular Disease
• Interventions: Drug: Conventional therapy group; Drug: Intensive targeting group

• Registration Number: NCT05361421
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Study Start: 2022-07-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy group	Conventional therapy group	Initiate and maintain moderate intensity statin therapy
Intensive targeting group	Intensive targeting group	Intensive lipid loweroing therapy with LDL-cholesterol goal of \<55mg/dL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoint	3 years	1. Each component of primary endpoint; 2. 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; 3. Rate of cross-over into the non-allocated therapy regimen (1, 2, and 3 years after enrollment)
Safety endpoint	3 years	1. New-onset diabetes mellitus, worsening of glycemic control, or homeostatic model assessment (HOMA)-index; 2. Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage; 3. Elevation of muscle enzymes (CPK \> 4 x UNL); 4. Elevation of hepatic enzymes (AST, ALT, or both ≥ 3 x UNL); 5. Elevation of serum creatinine level (\>50% from baseline); 6. Change of proteinuria; 7. Diagnosis of cancer; 8. Operation due to cataract; 9. Major bleeding (BARC 2, 3, or 5)

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of