Intensive LDL-cholesterol targeting for elderly patients with cardiovascular disease
Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
PHASE4 · Yonsei University · NCT05361421
This study is testing whether lowering LDL-cholesterol levels more aggressively helps older patients with heart disease feel better compared to standard cholesterol treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05361421 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of intensive LDL-cholesterol lowering therapy to conventional moderate intensity statin therapy in elderly patients aged 75 and older who have documented cardiovascular disease. The goal is to determine the clinical outcomes associated with targeting LDL-cholesterol levels below 55 mg/dL versus standard treatment. By focusing on this age group, which has been underrepresented in previous research, the study aims to provide valuable insights into the management of cardiovascular disease in older adults.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 75 and older with a history of cardiovascular disease.
Not a fit: Patients who have had a myocardial infarction or stroke within the past year or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for elderly patients through more effective cholesterol management.
How similar studies have performed: Previous studies have shown success with intensive LDL-cholesterol lowering in younger populations, but this approach in elderly patients is less explored and could provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Byeong-Keuk Kim
- Email: KIMBK@yuhs.ac
- Phone: 82-02-2228-8465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Disease