Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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)
- Percutaneous Coronary Intervention
- Peripheral Endovascular Intervention
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Duke University
- Enrolment target
- 6,000
- Started
- 23 July 2025
- Main results due
- October 2029
- Study sites
- 141
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(141)
Advanced Cardiovascular LLC
Alexander City, Alabama, United States
Recruiting
Cardiology, PC
Birmingham, Alabama, United States
Recruiting
Heart Center Research, LLC
Huntsville, Alabama, United States
Recruiting
IMS Cardiology
Avondale, Arizona, United States
Recruiting
Cardiology Associates Research Group
Jonesboro, Arkansas, United States
Recruiting
Arkansas Cardiology
Little Rock, Arkansas, United States
Recruiting
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Recruiting
Pacific Oaks Medical Group
Beverly Hills, California, United States
Recruiting
Cardiovascular Institute of San Diego
Chula Vista, California, United States
Recruiting
John Muir Medical Center - Concord Campus
Concord, California, United States
Recruiting
Valley Clinical Trials
Covina, California, United States
Withdrawn
Thrive Clinical Research Group
Glendora, California, United States
Recruiting
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, United States
Recruiting
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, United States
Recruiting
Riverside Community Hospital
Riverside, California, United States
Recruiting
Kaiser Permanente - San Diego
San Diego, California, United States
Recruiting
San Diego Cardiac Center
San Diego, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Recruiting
The Heart Medical Group
Van Nuys, California, United States
Recruiting
FOMAT - West Coast Research Center
Ventura, California, United States
Recruiting
Interventional Cardiology Medical Group
West Hills, California, United States
Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Recruiting
Aurora Denver Cardiology Associates - Englewood
Englewood, Colorado, United States
Recruiting
ClinRe 001-001
Thornton, Colorado, United States
Recruiting
Bridgeport Hospital
Bridgeport, Connecticut, United States
Recruiting
Nuvance Health- Danbury Hospital
Danbury, Connecticut, United States
Recruiting
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
Recruiting
BayCare Medical Group
Clearwater, Florida, United States
Recruiting
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Recruiting
Pioneer Clinical Studies
Coral Gables, Florida, United States
Recruiting
Arrow Clinical Trails
Daytona Beach, Florida, United States
Recruiting
UF Health Jacksonville
Jacksonville, Florida, United States
Recruiting
First Coast Cardiovascular Institute, PA
Jacksonville, Florida, United States
Recruiting
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Largo, Florida, United States
Recruiting
Inpatient Research Clinic, LLC
Miami Lakes, Florida, United States
Recruiting
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Recruiting
Gulf Coast Heart and Vascular
Panama City, Florida, United States
Recruiting
Charlotte Heart & Vascular Center, PA
Port Charlotte, Florida, United States
Recruiting
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, United States
Active, not recruiting
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Recruiting
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States
Recruiting
Javara, Inc.
Peachtree City, Georgia, United States
Withdrawn
Atlanta Heart Specialists LLC
Tucker, Georgia, United States
Recruiting
University of Illinois Chicago
Chicago, Illinois, United States
Recruiting
Advocate Aurora Lutheran General Hospital
Park Ridge, Illinois, United States
Recruiting
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, United States
Recruiting
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
Recruiting
Heart Center of Lake County
Merrillville, Indiana, United States
Recruiting
Reid Physician Associates
Richmond, Indiana, United States
Recruiting
Iowa Heart Center
West Des Moines, Iowa, United States
Recruiting
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Recruiting
Kansas Nephrology Physicians, PA
Wichita, Kansas, United States
Recruiting
Research Integrity, LLC
Owensboro, Kentucky, United States
Recruiting
Grace Research, LLC
Bossier City, Louisiana, United States
Recruiting
Louisiana Heart Center
Covington, Louisiana, United States
Recruiting
Tulane School of Medicine
New Orleans, Louisiana, United States
Recruiting
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States
Recruiting
Monroe Research LLC
West Monroe, Louisiana, United States
Recruiting
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
Recruiting
MedStar Southern Maryland Hospital Center
Clinton, Maryland, United States
Recruiting
Showing 60 of 141 sites — filter to narrow it down. 137 of the 141 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06909565. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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