RecruitingPercutaneous Coronary InterventionPeripheral Endovascular Intervention

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

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

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.

Sponsor: Duke University

You may qualify if…

✓ 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

You may not qualify if…

✕ 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