V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.
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
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
Duke University
Lead sponsor
Novartis Pharmaceuticals
Collaborator
Colorado Prevention Center
Collaborator
Mount Sinai Hospital, New York
Collaborator