Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Study Phase: Phase 4
Recruitment Status: Recruiting
Start Date: July 23, 2025
End Date: December 01, 2029
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.
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