Comparing Lower and Higher LDL Cholesterol Targets in Patients 75 Years and Older with Atherosclerotic Cardiovascular Disease

What this Trial Is About

Researchers are evaluating whether lowering LDL cholesterol LDL-C to a target range of 25 to less than 70 mgdL is better than a target range of 70 to less than 100 mgdL for preventing major cardiovascular events in patients aged 75 years or older with atherosclerotic cardiovascular disease ASCVD. The study also examines if the lower LDL-C target is as safe as the higher target regarding major safety events like hemorrhagic stroke, new diabetes, muscle problems, neurocognitive issues, cancer, cataracts, or liver disorders. This trial addresses the uncertainty about optimal LDL-C targets in older adults, as most previous studies excluded this age group. Participants are randomly assigned to one of two groups with different LDL-C targets either 25 to less than 70 mgdL or 70 to less than 100 mgdL. Doctors adjust lipid-lowering medications, including statins, ezetimibe, or PCSK9 inhibitors, to help patients reach their assigned LDL-C goal. Follow-up visits occur at 1, 2, 4, 6, and 12 months, then every 6 months up to 36 months, with ongoing monitoring of LDL-C levels, cardiovascular events, safety issues, muscle symptoms, quality of life, and cognitive function. The study will continue until 726 major cardiovascular events are confirmed. During the study, participants undergo regular lab tests to measure lipid profiles and are assessed for any cardiovascular or safety events. Patient-reported quality of life and cognitive function are also evaluated using standardized questionnaires. Researchers will analyze time to first major cardiovascular event and major safety events over an average follow-up of about 42 months. All evaluations follow the intention-to-treat principle, ensuring all patients are included in the analysis regardless of treatment adherence.

LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)