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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Percutaneous Coronary Intervention, Peripheral Endovascular Intervention

In brief

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.

Key facts

Study ID

NCT06909565

Run by

Duke University

People needed

6000

Starts

2025-07-23

Expected to finish

2029-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Advanced Cardiovascular LLC — Alexander City, Alabama, United States (enrolling)
• Heart Center Research, LLC — Huntsville, Alabama, United States (enrolling)
• Cardiology, PC — Birmingham, Alabama, United States (enrolling)
• Arkansas Cardiology — Little Rock, Arkansas, United States (enrolling)
• Pacific Oaks Medical Group — Beverly Hills, California, United States (enrolling)
• Cardiovascular Institute of San Diego — Chula Vista, California, United States (enrolling)
• John Muir Medical Center - Concord Campus — Concord, California, United States (enrolling)
• Cardiology Associates Research Group — Jonesboro, Arkansas, United States (enrolling)
• Thrive Clinical Research Group — Glendora, California, United States (enrolling)
• Radin Cardiovascular Medical Group, Inc — Newport Beach, California, United States (enrolling)
• Valley Clinical Trials, LLC - Flourish Research — Northridge, California, United States (enrolling)
• Riverside Community Hospital — Riverside, California, United States (enrolling)
• Kaiser Permanente - San Diego — San Diego, California, United States (enrolling)
• San Diego Cardiac Center — San Diego, California, United States (enrolling)
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
• The Heart Medical Group — Van Nuys, California, United States (enrolling)
• FOMAT - West Coast Research Center — Ventura, California, United States (enrolling)
• Interventional Cardiology Medical Group — West Hills, California, United States (enrolling)
• ClinRe 001-001 — Thornton, Colorado, United States (enrolling)
• Bridgeport Hospital — Bridgeport, Connecticut, United States (enrolling)
• Nuvance Health- Danbury Hospital — Danbury, Connecticut, United States (enrolling)
• Cardiology Associates of Fairfield County — Stamford, Connecticut, United States (enrolling)
• BayCare Medical Group — Clearwater, Florida, United States (enrolling)
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States (enrolling)
• Pioneer Clinical Studies — Coral Gables, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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