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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06909565

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL (Drug)
    300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter
  • Normal Saline (Placebo) (Drug)
    Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter

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

Conditions

Percutaneous Coronary Intervention Peripheral Endovascular Intervention

Locations

  • Advanced Cardiovascular LLC — Alexander City, Alabama, United States
  • Cardiology, PC — Birmingham, Alabama, United States
  • Heart Center Research, LLC — Huntsville, Alabama, United States
  • IMS Cardiology — Avondale, Arizona, United States
  • Cardiology Associates Research Group — Jonesboro, Arkansas, United States
  • Arkansas Cardiology — Little Rock, Arkansas, United States
  • Arkansas Heart Hospital — Little Rock, Arkansas, United States
  • Pacific Oaks Medical Group — Beverly Hills, California, United States
  • Cardiovascular Institute of San Diego — Chula Vista, California, United States
  • John Muir Medical Center - Concord Campus — Concord, California, United States
  • Valley Clinical Trials — Covina, California, United States
  • Thrive Clinical Research Group — Glendora, California, United States
  • Radin Cardiovascular Medical Group, Inc — Newport Beach, California, United States
  • Valley Clinical Trials, LLC - Flourish Research — Northridge, California, United States
  • Riverside Community Hospital — Riverside, California, United States
  • Kaiser Permanente - San Diego — San Diego, California, United States
  • San Diego Cardiac Center — San Diego, California, United States
  • Sutter Health Heart and Vascular — San Francisco, California, United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
  • The Heart Medical Group — Van Nuys, California, United States
  • FOMAT - West Coast Research Center — Ventura, California, United States
  • Interventional Cardiology Medical Group — West Hills, California, United States
  • University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
  • Aurora Denver Cardiology Associates - Englewood — Englewood, Colorado, United States
  • ClinRe 001-001 — Thornton, Colorado, United States
  • Bridgeport Hospital — Bridgeport, Connecticut, United States
  • Nuvance Health- Danbury Hospital — Danbury, Connecticut, United States
  • Cardiology Associates of Fairfield County — Stamford, Connecticut, United States
  • BayCare Medical Group — Clearwater, Florida, United States
  • Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
  • Pioneer Clinical Studies — Coral Gables, Florida, United States
  • Arrow Clinical Trails — Daytona Beach, Florida, United States
  • Cardiology Research Associates — Daytona Beach, Florida, United States
  • UF Health Jacksonville — Jacksonville, Florida, United States
  • First Coast Cardiovascular Institute, PA — Jacksonville, Florida, United States
  • Clearwater Cardiovascular and Interventional Consultants- Bardmoor — Largo, Florida, United States
  • Inpatient Research Clinic, LLC — Miami Lakes, Florida, United States
  • Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
  • Gulf Coast Heart and Vascular — Panama City, Florida, United States
  • Charlotte Heart & Vascular Center, PA — Port Charlotte, Florida, United States
  • Clearwater Cardiovascular Consultants — Safety Harbor, Florida, United States
  • Tampa Cardiovascular Interventions and Research — Tampa, Florida, United States
  • Northeast Georgia Heart Center, PC — Gainesville, Georgia, United States
  • Javara, Inc. — Peachtree City, Georgia, United States
  • Atlanta Heart Specialists LLC — Tucker, Georgia, United States
  • University of Illinois Chicago — Chicago, Illinois, United States
  • Advocate Aurora Lutheran General Hospital — Park Ridge, Illinois, United States
  • OSF HealthCare Cardiovascular Institute — Rockford, Illinois, United States
  • Midwest Cardiovascular Research and Education Foundation — Elkhart, Indiana, United States
  • Heart Center of Lake County — Merrillville, Indiana, United States
  • Reid Physician Associates — Richmond, Indiana, United States
  • Iowa Heart Center — West Des Moines, Iowa, United States
  • Midwest Heart and Vascular Specialists — Overland Park, Kansas, United States
  • Kansas Nephrology Physicians, PA — Wichita, Kansas, United States
  • Research Integrity, LLC — Owensboro, Kentucky, United States
  • Grace Research, LLC — Bossier City, Louisiana, United States
  • Louisiana Heart Center — Covington, Louisiana, United States
  • Tulane School of Medicine — New Orleans, Louisiana, United States
  • Cardiovascular Solutions, LLC — Shreveport, Louisiana, United States
  • Monroe Research LLC — West Monroe, Louisiana, United States
  • Northern Light Eastern Maine Medical Center — Bangor, Maine, United States
  • MedStar Southern Maryland Hospital Center — Clinton, Maryland, United States
  • Capitol Cardiology Associates PA — Lanham, Maryland, United States
  • Shady Grove Adventist Hospital — Rockville, Maryland, United States
  • TidalHealth Peninsula Regional — Salisbury, Maryland, United States
  • Jadestone Clinical Research, LLC — Silver Spring, Maryland, United States
  • Washington Vascular Specialists - ClinRe 001-136 — Takoma Park, Maryland, United States
  • UMH-Sparrow Clinical Research Institute — Lansing, Michigan, United States
  • MyMichigan Medical Center Midland — Midland, Michigan, United States
  • Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates — Rochester Hills, Michigan, United States
  • Aspirus Saint Luke's Hospital — Duluth, Minnesota, United States
  • Essentia Health-SMMC — Duluth, Minnesota, United States
  • JAVARA Inc, - Mankato Clinic — Mankato, Minnesota, United States
  • Stern Cardiovascular — Southaven, Mississippi, United States
  • Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
  • University of Missouri Health Care — Columbia, Missouri, United States
  • CHI Health Nebraska Heart — Grand Island, Nebraska, United States
  • Bryan Heart — Lincoln, Nebraska, United States
  • CHI Health Nebraska Heart — Lincoln, Nebraska, United States
  • Methodist Physicians Clinic Heart Consultants — Omaha, Nebraska, United States
  • Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
  • Advanced Heart Care LLC — Bridgewater, New Jersey, United States
  • Cardiovascular Associates of the Delaware Valley — Elmer, New Jersey, United States
  • Advanced Heart and Vascular Institute Of Hunterdon — Flemington, New Jersey, United States
  • Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
  • AtlantiCare Regional Medical Center — Pomona, New Jersey, United States
  • Cardiovascular Associates of the Delaware Valley — Sewell, New Jersey, United States
  • Presbyterian Heart Group — Albuquerque, New Mexico, United States
  • Capital Cardiology Associates — Albany, New York, United States
  • Sisters of Charity Hospital — Buffalo, New York, United States
  • Trinity Medical WNY, PC — Buffalo, New York, United States
  • Mount Sinai School of Medicine — New York, New York, United States
  • Hudson Valley Cardiovascular Practice PC — Poughkeepsie, New York, United States
  • University of Rochester Medical Center — Rochester, New York, United States
  • Richmond University Medical Center — Staten Island, New York, United States
  • Jacobi Medical Center — The Bronx, New York, United States
  • Asheville Cardiology Associates Research Department — Asheville, North Carolina, United States
  • Novant Health Clinical Research/Heart & Vascular Institute — Charlotte, North Carolina, United States
  • Mecklenburg Heart Specialists — Charlotte, North Carolina, United States
  • Javara Inc. — Fayetteville, North Carolina, United States
  • Moses H Cone Memorial Hospital — Greensboro, North Carolina, United States
  • Wake Forest University Health Sciences — High Point, North Carolina, United States
  • Duke Cardiology — Morrisville, North Carolina, United States
  • Duke Vascular Surgery and Vein Center at Brier Creek — Raleigh, North Carolina, United States
  • Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
  • Aultman Hospital — Canton, Ohio, United States
  • Heart House Research Foundation LLC — Springfield, Ohio, United States
  • ProMedica Toledo Hospital — Toledo, Ohio, United States
  • Genesis HealthCare System — Zanesville, Ohio, United States
  • South Oklahoma Heart Research, LLC — Oklahoma City, Oklahoma, United States
  • St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
  • Capital Area Research LLC — Camp Hill, Pennsylvania, United States
  • Wellspan Chambersburg Hospital — Chambersburg, Pennsylvania, United States
  • Penn Lancaster General Health Research Institute — Lancaster, Pennsylvania, United States
  • Cardiology Associates of West Reading — West Reading, Pennsylvania, United States
  • WellSpan Heart and Vascular Research — York, Pennsylvania, United States
  • AnMed Health Medical Center — Anderson, South Carolina, United States
  • Monument Health Clinical Research — Rapid City, South Dakota, United States
  • Stern Cardiovascular Center — Germantown, Tennessee, United States
  • Ballad Health System — Greeneville, Tennessee, United States
  • Apex Research Foundation, LLC — Jackson, Tennessee, United States
  • The Jackson Clinic, PA — Jackson, Tennessee, United States
  • TriStar Centennial Medical Center — Nashville, Tennessee, United States
  • PharmaTex Research — Amarillo, Texas, United States
  • Amarillo Heart Clinical Research Institute, Inc. — Amarillo, Texas, United States
  • Austin Heart — Austin, Texas, United States
  • Javara inc. — Conroe, Texas, United States
  • Texas Heart Institute — Houston, Texas, United States
  • Vital Heart and Vein — Humble, Texas, United States
  • Texas Cardiology Associates of Houston — Kingwood, Texas, United States
  • Heart Institute of East Texas — Lufkin, Texas, United States
  • DHR Health Institute for Research — McAllen, Texas, United States
  • Austin Heart PLLC — Round Rock, Texas, United States
  • Austin Heart — San Marcos, Texas, United States
  • Northwest Houston Heart Center — Tomball, Texas, United States
  • Viva Heart and Vein — Tomball, Texas, United States
  • Intermountain Medical Center — Murray, Utah, United States
  • TPMG Clinical Research — Newport News, Virginia, United States
  • Sentara Norfolk General Hospital — Norfolk, Virginia, United States
  • Chippenham Hospital — Richmond, Virginia, United States
  • Winchester Cardiology and Vascular Medicine — Winchester, Virginia, United States
  • MultiCare Institute for Research and Innovation — Puyallup, Washington, United States
  • MultiCare Institute for Research and Innovation — Tacoma, Washington, United States
  • Bellin Memorial Hospital — Green Bay, Wisconsin, United States
  • Aurora Saint Luke's Medical Center — Milwaukee, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record