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

Yonsei University

Status and phase: Enrolling; Phase 4

Conditions: Cardiovascular Disease

Treatments: Drug: Conventional therapy group; Drug: Intensive targeting group

Study type: Interventional

Funder types: Other

Identifiers

NCT05361421

4-2022-0259

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,200 participants in 2 patient groups

Intensive targeting group

Experimental group

Description:

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

Treatment:

Drug: Intensive targeting group

Conventional therapy group

Active Comparator group

Description:

Initiate and maintain moderate intensity statin therapy

Treatment:

Drug: Conventional therapy group