Guaratingueta

Researchers are evaluating the effects of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol in patients admitted to the hospital after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This phase 4, multi-country, open-label clinical trial focuses on patients who have been stabilized in the hospital following these acute events. The study aims to understand how this combination impacts LDL cholesterol levels, patient-reported outcomes, and healthcare resource use in a real-world hospital setting. Participants are randomly assigned in a 1:1 ratio to receive either inclisiran plus usual care or usual care alone. Inclisiran is given as a subcutaneous injection on day 1, day 90, and day 270. Usual care includes treatments approved in the patient's country after the acute event, which may include educational interventions following local guidelines. The study tracks the participants over a period of approximately 330 days, including initial treatment and follow-up visits. During the study, participants undergo assessments of LDL cholesterol levels at baseline and on day 330 to measure changes. Researchers also evaluate patient-reported outcomes and monitor healthcare resource use. The study ensures participants are stable before randomization and follows them through their hospital stay and post-discharge period. Completion of the study is marked by the final visit and associated evaluations on day 330, allowing for a comprehensive evaluation of the treatments' impact over nearly a year.