V-INTERVENTION

V-INTERVENTION
Enrolling By Invitation
18 years - 99 years
All
Phase 4
30 participants needed
1 Location

Brief description of 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 add-on with statin therapy and on the market to lower LDL-C in high-risk populations.

Detailed description of study

This is a randomized, double-blind, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants presenting for elective or urgent percutaneous coronary or peripheral endovascular intervention (PCI or PVI). At the time of a successful revascularization procedure or up to 14 days following the procedure, participants will be randomized (1:1) and administered the first dose of inclisiran or placebo.

The study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 18 years - 99 years
  • Gender: All

Inclusion

  • ≥ 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

  • 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

Updated on 06 Apr 2026. Study ID: 26-0180
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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