Overview

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

Status:
Not yet recruiting

Trial end date:
2027-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yonsei University

Criteria

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

7. Inability to understand or read the informed content