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

Launched by DUKE UNIVERSITY · Mar 27, 2025

Keywords

ClinConnect Summary

The clinical trial, called V-INTERVENTION, is studying a medication called inclisiran to see if it can help prevent serious heart and limb problems in patients who have recently undergone procedures to open blocked arteries, known as percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI). Inclisiran is an injection given twice a year that helps lower bad cholesterol levels and is already approved for patients at high risk of heart issues when used alongside other cholesterol-lowering medications called statins.

To participate in this trial, individuals must be at least 18 years old and have recently had a successful PCI or PVI. They should not have any serious liver or kidney diseases, and they cannot be pregnant or breastfeeding. Participants will be randomly assigned to receive either inclisiran or a placebo (an inactive treatment) and will be monitored over time to see how well inclisiran works in preventing future cardiovascular problems. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait until it officially begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent must be obtained prior to participation in the study.
• • Males or females ≥ 18 years of age
• • Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
• • Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention
• Exclusion Criteria:
• • Planned future PCI or PVI
• • Current or planned use of an open-label PCSK9 inhibitor during the study
• • Any prior treatment with inclisiran
• • Active or planned participation in another clinical study involving investigational drugs or devices during the study
• • Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results
• • Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities
• • Patients taking prohibited therapies as listed in Section 6.6.3
• • Pregnant or breast-feeding women