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Inclisiran to prevent heart and limb events after coronary or peripheral artery procedures

Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

Phase 4 Interventional Duke University · NCT06909565

This trial will try a twice-yearly inclisiran injection in adults who just had coronary or peripheral artery procedures to see if it lowers the chance of major heart or limb events.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment6000 (estimated)
Ages18 Years and up
SexAll
SponsorDuke University Academic / other
Locations96 sites (Alexander City, Alabama and 95 other locations)
Trial IDNCT06909565 on ClinicalTrials.gov

What this trial studies

V-INTERVENTION (CKJX839D1US04R) is a pragmatic, randomized, double-blind, placebo-controlled, multicenter, event-driven Phase 4 trial enrolling about 6,000 adults after successful elective or urgent PCI or lower extremity PVI. Participants are randomized 1:1 to receive 300 mg inclisiran subcutaneously on Day 1 (or within 14 days of the procedure), at Month 3, and every six months thereafter, or matching placebo, with stratification by coronary versus peripheral procedure. The trial collects major adverse cardiovascular and limb events in a real-world clinical setting to determine clinical benefit beyond LDL-C lowering. The design is intended to reflect typical US practice and to inform practical implementation of inclisiran therapy.

Who should consider this trial

Good fit: Adults aged 18 or older who have undergone a successful percutaneous coronary intervention or lower extremity peripheral endovascular intervention for symptomatic CAD or PAD and can receive the first dose within 14 days are the intended participants.

Not a fit: Patients with serious liver or metabolic disease, end-stage kidney disease, active cancer, prior inclisiran treatment, planned future PCI/PVI, or planned use of open-label PCSK9 inhibitors are unlikely to benefit from enrolling.

Why it matters

Potential benefit: If successful, inclisiran could reduce the risk of heart attacks, strokes, and limb complications after revascularization in high-risk patients.

How similar studies have performed: Previous ORION program trials demonstrated robust and durable LDL-C lowering with inclisiran and supported regulatory approval as an adjunct to statins, but randomized evidence specifically showing reduction in major cardiovascular or limb events remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Alexander City, Alabama and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Percutaneous Coronary InterventionPeripheral Endovascular InterventioninclisiranCoronary Artery DiseasehypercholesterolemiaCardiovascular DiseasePercutaneous Endovascular InterventionPCSK9
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.