Study of Inclisiran Injection to Prevent Major Heart and Limb Events After Coronary or Peripheral Artery Procedures

What this Trial Is About

This trial evaluates inclisiran, a subcutaneous injection given twice yearly, for preventing major cardiovascular and limb events in patients who have undergone percutaneous coronary intervention PCI or peripheral endovascular intervention PVI. The study focuses on patients with atherosclerotic cardiovascular disease, including coronary artery disease and peripheral artery disease, aiming to assess inclisirans role alongside standard care in real-world settings. It is a randomized, double-blind, placebo-controlled, phase 4 study involving about 6,000 participants. Participants will receive either 300 mg of inclisiran or a matching placebo by subcutaneous injection on Day 1 within 14 days of their intervention, at Month 3, and then every 6 months thereafter. The study compares inclisiran to placebo while all participants continue their usual care prescribed by their physicians. The treatment duration varies with event accrual and follow-up but is expected to last approximately 4 years, with individual participants receiving treatment for up to about 45 months. Throughout the study, participants will be regularly monitored for major adverse cardiovascular events MACE and major adverse limb events MALE up to about 4 years from randomization. Additional assessments include tracking cardiovascular death, all-cause death, and venous thromboembolic events. The study includes safety monitoring and follow-up visits to evaluate the outcomes and adherence to the intervention and usual care during the entire study period.

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention