Study of 1-Year Outcomes After Starting Inclisiran Soon After a Heart Attack in Adults with High Cholesterol

What this Trial Is About

Researchers are evaluating clinical outcomes for patients who begin inclisiran treatment within about two weeks after experiencing a heart attack STEMI or non-STEMI. This observational study focuses on patients in Russia and aims to understand the effects of inclisiran on lipid profiles, safety, atherosclerotic plaque status using carotid ultrasound, and the rates of hospitalizations and intensive follow-up over a 12-month period. Participants receive their first inclisiran injection approximately 14 days after their heart attack. The study observes changes in lipid levels at baseline, 3, 9, and 12 months, as well as plaque progression or regression over the year. Researchers also monitor adverse events, therapy discontinuation, hospital readmissions, emergency care visits, and the timing of dispensary observation. During the 12 months of participation, patients undergo lipid profile testing, carotid ultrasound scans, and safety evaluations at specified intervals. The main measure is the number of patients experiencing atherosclerotic cardiovascular disease events within a year after starting inclisiran in addition to their usual therapy. Secondary assessments include LDL cholesterol levels, plaque changes, adverse events, rehospitalizations, and use of emergency services, all tracked to evaluate the therapys impact and safety in real-world settings.

Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients