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

Summary

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.

Eligibility

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

Conditions3

Locations53 sites

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