Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Yonsei University
1,200 participants
Jul 19, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age ≥75 years
- 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 Criteria6
- MI or stroke within 1 year
- LDL-cholesterol level less than 55 mg/dL without statin therapy
- Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- Allergy or hypersensitivity to any statin
- Life expectancy less than 1 years
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Only moderate intensity statin therapy (atorvastatin 5, 10, and 20mg ) are allowed. Ezetimibe or PCSK-9 inhibitor is not allowed to use.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05361421