Study of Inclisiran Plus Usual Care Versus Usual Care Alone to Lower LDL Cholesterol After Acute Heart or Stroke Events in Latin America

What this Trial Is About

Researchers are investigating the impact of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol LDL-C in patients hospitalized after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This multi-country, open-label, randomized clinical trial focuses on patients stabilized and ready for discharge following such events. The study explores the real-world effects on LDL-C levels, patient-reported outcomes, and healthcare resource use. Participants are divided into two groups one receives usual care, which includes physical activity, diet changes, and standard cholesterol-lowering medications like statins and others the other group receives the same usual care plus inclisiran injections at baseline, 90 days, and 270 days. Usual care treatments vary by country but commonly involve statins and other cholesterol-lowering drugs. This phase 4 study measures the effectiveness of inclisiran added to usual care over approximately 11 months. During the study, participants will have assessments at baseline and at day 330 to measure changes in LDL-C and other outcomes such as the proportion of patients achieving specific LDL-C reduction goals. Researchers also track the timing of statin initiation during the study period. Patient health, adherence to treatment, and safety will be monitored throughout. The study concludes for each participant after the last visit and related assessments at day 330.

LATAM LOWERS LDL-C