V-INTERVENTION

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

About the Study

Currently Recruiting: Participants

Study Drug/Intervention: Inclsiran

Anticipated Sample Size: 6,000 patients

Study Timeline: This study is expected to conclude October 2029

ClinicalTrials.gov ID:  NCT06909565

 

What is V-INTERVENTION?

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 is on the market to lower LDL-C in high-risk populations.

Unique Aspects of the Project

Phase IV Clinical is assessing a reduction in recurrence rates in patients who have had a previous stroke, heart attack, or limb event after receiving dosing of inclisiran vs placebo after a revascularization procedure.

Inclusion & Exclusion Criteria

Inclusion Criteria

Patients must meet all of the following 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

Any of the following criteria will exclude potential patients from the study:

  • 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 breastfeeding women

Note: Other protocol-defined Inclusion/ Exclusion criteria may apply

Patient Population

Patients who have had a previous cardiac or limb event undergoing a revascularization procedure.

Study Sites

Over 125 locations in the United States. Visit the ClinicalTrials.gov Study Details page to view all locations.

Study Timeline

Duration of Study Participation

Anticipated duration is 36 months

Study Follow-Up

Visits 1 & 2 can be completed together; Visit 3 is 90 days after Visit 2; Additional visits every 6 months after Visit 3.

Sponsor/Funding

Funding: Novartis

Trial Sponsor: Duke Clinical Research Institute

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