Early Hospital Initiation of Inclisiran Treatment in Adults With Acute Coronary Syndromes to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the effects of inclisiran in people with serious heart conditions known as acute coronary syndromes ACS, including STEMI or NSTEMI. The study aims to compare inclisiran to a placebo when given early after hospital admission, alongside standard treatment, to learn about its safety and effectiveness in this patient group. Participants will be randomly assigned to receive either inclisiran sodium 300 mg or a matching placebo by subcutaneous injection at randomization Day 1 and again on Day 90. The treatment begins before hospital discharge and is given on top of standard treatments, which may include high-intensity statins or non-statin lipid-lowering therapies. The study includes a 150-day double-blind treatment period, followed by a safety follow-up call 30 days after the end of the study. Participants will take part in a screening visit within 7 days of hospital admission and a randomization visit before discharge. Safety calls will be made during the treatment period between in-person visits. Researchers will assess changes in LDL cholesterol levels from baseline to Day 150 to evaluate the treatments effect. The total study duration for each participant is approximately 150 days, including follow-up monitoring to ensure participant safety.

Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes