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Inclisiran versus placebo for forebygging av store bivirkninger (V-INTERVENTION)

27. oktober 2026 oppdatert av: Duke University

Evaluering av Inclisiran versus placebo for forebygging av store bivirkninger i kardiovaskulære og lemmer hos pasienter som gjennomgår perkutan koronar intervensjon eller perifer endovaskulær intervensjon (V-intervensjon)

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

CKJX839D1US04R is a pragmatic, randomized, double-blind, parallel group, placebo-controlled, multicenter, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants presenting for elective or urgent percutaneous coronary or peripheral endovascular intervention (PCI or PVI). At the time of a successful revascularization procedure or up to 14 days following the procedure, participants will be randomized and administered the first dose of inclisiran or corresponding placebo in a 1:1 fashion, stratified by the type of index arterial revascularization procedure, either coronary (i.e., PCI) or lower extremity (i.e., PV).

The enrollment population will be representative of typical patients in the US with atherosclerotic cardiovascular disease, either coronary artery disease (CAD) or peripheral artery disease (PAD), and the trial endpoints are designed to be scientifically relevant and clinically meaningful to patients, clinicians, and other persons involved in the care of cardiovascular patients. The trial is designed to also understand how inclisiran therapy can be implemented in real-world clinical practice settings.

The expected enrollment of the trial is approximately 6,000 participants, randomized in a 1:1 fashion to receive inclisiran or placebo, within 14 days of successful percutaneous coronary or lower extremity peripheral endovascular intervention for symptomatic atherosclerotic cardiovascular disease (ASCVD).

Inclisiran sodium or corresponding placebo will be administered by s.c. injection to participants presenting for percutaneous coronary or peripheral endovascular intervention, in addition to usual care according to their individual medical history. All participants randomized to the treatment arm will receive inclisiran in addition to usual care per their regular physician direction, and those participants randomized to placebo will receive matching placebo, as well as usual care treatment, according to their treating physician.

Study duration is determined by event accrual consistent with the event-driven design, i.e., when approximately 2380 primary composite events have occurred and at least 50% of participants have at least 36 months of follow-up. Assuming 18 months of recruitment at a uniform rate, the last patients enrolled will have about 27 months of follow-up. Therefore, study duration should be approximately 4 years.

The study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.

Studietype

Intervensjonell

Registrering (Antatt)

6000

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Alabama
      • Alexander City, Alabama, Forente stater, 35010
        • Rekruttering
        • Advanced Cardiovascular LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brian Foley, MD
      • Birmingham, Alabama, Forente stater, 35211
        • Rekruttering
        • Cardiology, PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hutton Brantley, MD
      • Huntsville, Alabama, Forente stater, 35801
        • Rekruttering
        • Heart Center Research, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Henry Chen, MD
    • Arizona
      • Avondale, Arizona, Forente stater, 85392
        • Rekruttering
        • IMS Cardiology
        • Ta kontakt med:
        • Hovedetterforsker:
          • Riyaz Sumar, MD
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • Rekruttering
        • Cardiology Associates Research Group
        • Hovedetterforsker:
          • Ahmed Ahmed, MD
        • Ta kontakt med:
      • Little Rock, Arkansas, Forente stater, 72205
        • Rekruttering
        • Arkansas Cardiology
        • Hovedetterforsker:
          • David Jones, MD
        • Ta kontakt med:
      • Little Rock, Arkansas, Forente stater, 72211
        • Rekruttering
        • Arkansas Heart Hospital
        • Hovedetterforsker:
          • Ian Cawich, MD
        • Ta kontakt med:
    • California
      • Beverly Hills, California, Forente stater, 90211
        • Rekruttering
        • Pacific Oaks Medical Group
        • Hovedetterforsker:
          • Ramprasad Dandillaya, MD
        • Ta kontakt med:
      • Chula Vista, California, Forente stater, 91911
        • Rekruttering
        • Cardiovascular Institute of San Diego
        • Hovedetterforsker:
          • Milind Parikh, MD
        • Ta kontakt med:
      • Concord, California, Forente stater, 94520
      • Covina, California, Forente stater, 91723
        • Tilbaketrukket
        • Valley Clinical Trials
      • Glendora, California, Forente stater, 91740
        • Rekruttering
        • Thrive Clinical Research Group
        • Hovedetterforsker:
          • Fahed Bitar, MD
        • Ta kontakt med:
      • Newport Beach, California, Forente stater, 92663
        • Rekruttering
        • Radin Cardiovascular Medical Group, Inc
        • Hovedetterforsker:
          • Michael Radin, MD
        • Ta kontakt med:
      • Northridge, California, Forente stater, 91324
        • Rekruttering
        • Amicis Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heather Shenkman, MD
      • Northridge, California, Forente stater, 91325
        • Rekruttering
        • Valley Clinical Trials, LLC - Flourish Research
        • Hovedetterforsker:
          • Mehrdad Ariani, MD
        • Ta kontakt med:
      • Riverside, California, Forente stater, 92501
        • Rekruttering
        • Riverside Community Hospital
        • Hovedetterforsker:
          • Patrick Hu, MD
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92123
        • Rekruttering
        • San Diego Cardiac Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jiken Bhatt, MD
      • San Diego, California, Forente stater, 92123
        • Rekruttering
        • Kaiser Permanente - San Diego
        • Hovedetterforsker:
          • Bahram Khadivi, MD
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94109
        • Rekruttering
        • Sutter Health Heart and Vascular
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hernan Bazan, MD
      • Torrance, California, Forente stater, 90502
        • Rekruttering
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Quang Bui, MD
      • Van Nuys, California, Forente stater, 91406
        • Rekruttering
        • The Heart Medical Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Munaf Shamji, MD
      • Ventura, California, Forente stater, 93030
        • Rekruttering
        • FOMAT - West Coast Research Center
        • Hovedetterforsker:
          • David Blitzer, MD
        • Ta kontakt med:
      • West Hills, California, Forente stater, 91307
        • Rekruttering
        • Interventional Cardiology Medical Group
        • Hovedetterforsker:
          • Farhad Rafii, MD
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • University of Colorado Anschutz Medical Campus
        • Hovedetterforsker:
          • Connie Hess, MD
        • Ta kontakt med:
      • Englewood, Colorado, Forente stater, 80113
        • Rekruttering
        • Aurora Denver Cardiology Associates - Englewood
        • Hovedetterforsker:
          • Ehrin Armstrong, MD
        • Ta kontakt med:
      • Thornton, Colorado, Forente stater, 80023
        • Rekruttering
        • ClinRe 001-001
        • Hovedetterforsker:
          • Rajesh Sharma, MD
        • Ta kontakt med:
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06610
        • Rekruttering
        • Bridgeport Hospital
        • Hovedetterforsker:
          • Edward Tuohy, MD
        • Ta kontakt med:
      • Danbury, Connecticut, Forente stater, 06810
        • Rekruttering
        • Nuvance Health- Danbury Hospital
        • Hovedetterforsker:
          • Hal Wasserman, MD
        • Ta kontakt med:
      • Stamford, Connecticut, Forente stater, 06305
        • Rekruttering
        • Cardiology Associates of Fairfield County
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Edward Portnay, MD
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Rekruttering
        • Clearwater Cardiovascular Consultants
        • Ta kontakt med:
        • Hovedetterforsker:
          • Masood Gilani, MD
      • Clearwater, Florida, Forente stater, 33756
        • Rekruttering
        • BayCare Medical Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rakesh Sharma, MD
      • Coral Gables, Florida, Forente stater, 33134
        • Rekruttering
        • Pioneer Clinical Studies
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vinod Chainani, MD
      • Daytona Beach, Florida, Forente stater, 32117
        • Rekruttering
        • Cardiology Research Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dinesh Arab, MD
      • Daytona Beach, Florida, Forente stater, 32117
        • Rekruttering
        • Arrow Clinical Trails
        • Hovedetterforsker:
          • Charles Ross, MD
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32209
        • Rekruttering
        • UF Health Jacksonville
        • Hovedetterforsker:
          • Francesco Franchi, MD
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32256
        • Rekruttering
        • First Coast Cardiovascular Institute, PA
        • Hovedetterforsker:
          • Yazan Khatib, MD
        • Ta kontakt med:
      • Largo, Florida, Forente stater, 33777
        • Rekruttering
        • Clearwater Cardiovascular and Interventional Consultants- Bardmoor
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alexander Heckman, MD
      • Miami Lakes, Florida, Forente stater, 33014
        • Rekruttering
        • Inpatient Research Clinic, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Francisco Dieguez Jr, MD
      • Panama City, Florida, Forente stater, 32405
        • Rekruttering
        • Cardiovascular Institute of Northwest Florida
        • Hovedetterforsker:
          • Amir Haghighat, MD
        • Ta kontakt med:
      • Panama City, Florida, Forente stater, 32405
        • Rekruttering
        • Gulf Coast Heart and Vascular
        • Hovedetterforsker:
          • Ajay Labroo, MD
        • Ta kontakt med:
      • Port Charlotte, Florida, Forente stater, 33948
        • Rekruttering
        • Charlotte Heart & Vascular Center, PA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mario Lopez, MD
      • Safety Harbor, Florida, Forente stater, 34695
        • Aktiv, ikke rekrutterende
        • Clearwater Cardiovascular Consultants
      • Tampa, Florida, Forente stater, 33614
        • Rekruttering
        • Tampa Cardiovascular Interventions and Research
        • Hovedetterforsker:
          • Saihari Sadanandan, MD
        • Ta kontakt med:
    • Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Rekruttering
        • Northeast Georgia Heart Center, PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nima Ghasemzadeh, MD
      • Peachtree City, Georgia, Forente stater, 30269
        • Tilbaketrukket
        • Javara, Inc.
      • Tucker, Georgia, Forente stater, 30084
        • Rekruttering
        • Atlanta Heart Specialists LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Suh, MD
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • University of Illinois Chicago
        • Hovedetterforsker:
          • David Tofovic, MD
        • Ta kontakt med:
      • Park Ridge, Illinois, Forente stater, 60068
        • Rekruttering
        • Advocate Aurora Lutheran General Hospital
        • Hovedetterforsker:
          • Nishant Patel, MD
        • Ta kontakt med:
      • Peoria, Illinois, Forente stater, 61614
        • Rekruttering
        • OSF Multi-Specialty Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sudhir Mungee, MD
      • Rockford, Illinois, Forente stater, 61107
        • Rekruttering
        • OSF HealthCare Cardiovascular Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Montoya Taylor, MD
    • Indiana
      • Elkhart, Indiana, Forente stater, 46514
        • Rekruttering
        • Midwest Cardiovascular Research and Education Foundation
        • Hovedetterforsker:
          • Troy Weirick, MD
        • Ta kontakt med:
      • Merrillville, Indiana, Forente stater, 46410
        • Rekruttering
        • Heart Center of Lake County
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andre Artis, MD
      • Richmond, Indiana, Forente stater, 47374
        • Rekruttering
        • Reid Physician Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • John McGinty, MD
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50266
        • Rekruttering
        • Iowa Heart Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose Borromeo, MD
    • Kansas
      • Overland Park, Kansas, Forente stater, 66211
        • Rekruttering
        • Midwest Heart and Vascular Specialists
        • Hovedetterforsker:
          • Stephen Bloom, MD
        • Ta kontakt med:
      • Wichita, Kansas, Forente stater, 67214
        • Rekruttering
        • Kansas Nephrology Physicians, PA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Thomas Ashcom, MD
    • Kentucky
      • Owensboro, Kentucky, Forente stater, 42303
        • Rekruttering
        • Research Integrity, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kishor Vora, MD
    • Louisiana
      • Bossier City, Louisiana, Forente stater, 71111
        • Rekruttering
        • Grace Research, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • William Eaves, MD
      • Covington, Louisiana, Forente stater, 70433
        • Rekruttering
        • Louisiana Heart Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bruce Iteld, MD
      • New Orleans, Louisiana, Forente stater, 70112
        • Rekruttering
        • Tulane School of Medicine
        • Hovedetterforsker:
          • Anand Irimpen, MD
        • Ta kontakt med:
      • Shreveport, Louisiana, Forente stater, 71103
        • Rekruttering
        • Cardiovascular Solutions, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wenwu Zhang, MD
      • West Monroe, Louisiana, Forente stater, 71291
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • Rekruttering
        • Northern Light Eastern Maine Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alan Wiseman, MD
    • Maryland
      • Clinton, Maryland, Forente stater, 20735
        • Rekruttering
        • MedStar Southern Maryland Hospital Center
        • Hovedetterforsker:
          • Brian Case, MD
        • Ta kontakt med:
      • Lanham, Maryland, Forente stater, 20706
        • Rekruttering
        • Capitol Cardiology Associates PA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vivek Bahl, MD
      • Rockville, Maryland, Forente stater, 20850
        • Rekruttering
        • Shady Grove Adventist Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bryan White, MD
      • Salisbury, Maryland, Forente stater, 21804
        • Rekruttering
        • TidalHealth Peninsula Regional
        • Hovedetterforsker:
          • Steven Hearne, MD
        • Ta kontakt med:
      • Silver Spring, Maryland, Forente stater, 20904
        • Rekruttering
        • Jadestone Clinical Research, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Homan Ibrahim, MD
      • Takoma Park, Maryland, Forente stater, 20912
        • Rekruttering
        • Washington Vascular Specialists - ClinRe 001-136
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mubashar Choudry, MD
    • Michigan
      • Lansing, Michigan, Forente stater, 48912
        • Rekruttering
        • UMH-Sparrow Clinical Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Chad Link, MD
      • Lansing, Michigan, Forente stater, 48910
        • Rekruttering
        • McLaren Center for Research and Innovation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Majid Mughal, MD
      • Midland, Michigan, Forente stater, 48670
        • Rekruttering
        • MyMichigan Medical Center Midland
        • Ta kontakt med:
        • Hovedetterforsker:
          • William Felten, MD
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Trinity Health Oakland Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Abdul-Rahman Halabi
      • Rochester Hills, Michigan, Forente stater, 48307
        • Rekruttering
        • Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sandeep Khurana, MD
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • Rekruttering
        • Aspirus Saint Luke's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Scott Mikesell, MD
      • Duluth, Minnesota, Forente stater, 55805
        • Rekruttering
        • Essentia Health-SMMC
        • Hovedetterforsker:
          • Catherine Benziger, MD
        • Ta kontakt med:
      • Mankato, Minnesota, Forente stater, 56001
        • Rekruttering
        • JAVARA Inc, - Mankato Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Manpreet Kanwar, MD
    • Mississippi
      • Southaven, Mississippi, Forente stater, 38671
        • Rekruttering
        • Stern Cardiovascular
        • Hovedetterforsker:
          • Dharmesh Patel, MD
        • Ta kontakt med:
      • Tupelo, Mississippi, Forente stater, 38801
        • Rekruttering
        • Cardiology Associates of North Mississippi
        • Ta kontakt med:
        • Hovedetterforsker:
          • Richard Ballard, MD
    • Missouri
      • Columbia, Missouri, Forente stater, 65212
        • Rekruttering
        • University of Missouri Health Care
        • Hovedetterforsker:
          • Albert Chan, MD
        • Ta kontakt med:
    • Nebraska
      • Grand Island, Nebraska, Forente stater, 68803
        • Rekruttering
        • CHI Health Nebraska Heart
        • Ta kontakt med:
        • Hovedetterforsker:
          • Douglas Kosmicki, MD
      • Lincoln, Nebraska, Forente stater, 68526
        • Rekruttering
        • CHI Health Nebraska Heart
        • Ta kontakt med:
        • Hovedetterforsker:
          • Anuradha Tunuguntla, MD
      • Lincoln, Nebraska, Forente stater, 68506
        • Rekruttering
        • Bryan Heart
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rajeev Anchan, MD
      • Omaha, Nebraska, Forente stater, 68114
        • Rekruttering
        • Methodist Physicians Clinic Heart Consultants
        • Ta kontakt med:
        • Hovedetterforsker:
          • William Nester, MD
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Rekruttering
        • Dartmouth-Hitchcock Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jocelyn Beach, MD
    • New Jersey
      • Bridgewater, New Jersey, Forente stater, 08807
        • Rekruttering
        • Advanced Heart Care LLC
        • Hovedetterforsker:
          • Sharan Mahal, MD
        • Ta kontakt med:
      • Elmer, New Jersey, Forente stater, 08318
        • Rekruttering
        • Cardiovascular Associates of the Delaware Valley
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mark Gelernt, MD
      • Flemington, New Jersey, Forente stater, 08822
        • Rekruttering
        • Advanced Heart and Vascular Institute Of Hunterdon
        • Hovedetterforsker:
          • Andrey Espinoza, MD
        • Ta kontakt med:
      • Haddon Heights, New Jersey, Forente stater, 08035
        • Rekruttering
        • Cardiovascular Associates of the Delaware Valley
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sanford Gips, MD
      • Pomona, New Jersey, Forente stater, 08240
        • Rekruttering
        • AtlantiCare Regional Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sanjay Shetty, MD
      • Sewell, New Jersey, Forente stater, 08080
        • Rekruttering
        • Cardiovascular Associates of the Delaware Valley
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dilip Viswanath, MD
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Rekruttering
        • Presbyterian Heart Group
        • Hovedetterforsker:
          • Adam Banks, MD
        • Ta kontakt med:
    • New York
      • Albany, New York, Forente stater, 12211
        • Rekruttering
        • Capital Cardiology Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Krzysztof Drzymalski, MD
      • Buffalo, New York, Forente stater, 14214
        • Rekruttering
        • Sisters of Charity Hospital
        • Hovedetterforsker:
          • Paul Anain, MD
        • Ta kontakt med:
      • Buffalo, New York, Forente stater, 14214
        • Rekruttering
        • Trinity Medical WNY, PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Henry Meltser, MD
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Mount Sinai School of Medicine
        • Hovedetterforsker:
          • Prakash Krishnan, MD
        • Ta kontakt med:
      • Poughkeepsie, New York, Forente stater, 12601
        • Rekruttering
        • Hudson Valley Cardiovascular Practice PC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sunny Intwala, MD
      • Rochester, New York, Forente stater, 14642
        • Rekruttering
        • University of Rochester Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jeffery Bruckel, MD
      • Staten Island, New York, Forente stater, 10310
        • Rekruttering
        • Richmond University Medical Center
        • Hovedetterforsker:
          • Francesco Rotatori, MD
        • Ta kontakt med:
      • The Bronx, New York, Forente stater, 10461
        • Rekruttering
        • Jacobi Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Usman Khan, MD
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28803
        • Rekruttering
        • Asheville Cardiology Associates Research Department
        • Ta kontakt med:
        • Hovedetterforsker:
          • William Pomeroy, MD
      • Charlotte, North Carolina, Forente stater, 28207
        • Rekruttering
        • Mecklenburg Heart Specialists
        • Ta kontakt med:
        • Hovedetterforsker:
          • Aamer Qureshi, MD
      • Charlotte, North Carolina, Forente stater, 28204
        • Rekruttering
        • Novant Health Clinical Research/Heart & Vascular Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Pu, MD
      • Fayetteville, North Carolina, Forente stater, 28304
        • Rekruttering
        • Javara Inc.
        • Hovedetterforsker:
          • Amol Bakekar, MD
        • Ta kontakt med:
      • Greensboro, North Carolina, Forente stater, 27401
        • Rekruttering
        • Moses H Cone Memorial Hospital
        • Hovedetterforsker:
          • Muhammad Arida, MD
        • Ta kontakt med:
      • High Point, North Carolina, Forente stater, 27262
        • Rekruttering
        • Wake Forest University Health Sciences
        • Ta kontakt med:
        • Hovedetterforsker:
          • H. Barrett Cheek, MD
      • Morrisville, North Carolina, Forente stater, 27560
        • Rekruttering
        • Duke Cardiology
        • Hovedetterforsker:
          • Schuyler Jones, MD
        • Ta kontakt med:
      • Raleigh, North Carolina, Forente stater, 27617
        • Rekruttering
        • Duke Vascular Surgery and Vein Center at Brier Creek
        • Ta kontakt med:
        • Hovedetterforsker:
          • E. Hope Weissler, MD
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Rekruttering
        • Novant Health Forsyth Medical Center
        • Hovedetterforsker:
          • Nizar Noureddine, MD
        • Ta kontakt med:
    • Ohio
      • Canton, Ohio, Forente stater, 44710
        • Rekruttering
        • Aultman Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ramana Podugu, MD
      • Springfield, Ohio, Forente stater, 45505
        • Rekruttering
        • Heart House Research Foundation LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mian Bilal Alam, MD
      • Toledo, Ohio, Forente stater, 43606
        • Rekruttering
        • ProMedica Toledo Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mujeeb Sheikh, MD
      • Zanesville, Ohio, Forente stater, 43701
        • Rekruttering
        • Genesis HealthCare System
        • Ta kontakt med:
        • Hovedetterforsker:
          • Abdulhay Albirini, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73135
        • Rekruttering
        • South Oklahoma Heart Research, LLC
        • Hovedetterforsker:
          • Naeem Tahirkheli, MD
        • Ta kontakt med:
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • Rekruttering
        • St. Luke's University Health Network
        • Hovedetterforsker:
          • Amit Gupta, MD
        • Ta kontakt med:
      • Camp Hill, Pennsylvania, Forente stater, 17011
        • Rekruttering
        • Capital Area Research LLC
        • Hovedetterforsker:
          • Venkatesh Nadar, MD
        • Ta kontakt med:
      • Chambersburg, Pennsylvania, Forente stater, 17201
        • Rekruttering
        • Wellspan Chambersburg Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Aylmer Tang, MD
      • Lancaster, Pennsylvania, Forente stater, 17602
      • West Reading, Pennsylvania, Forente stater, 19611
        • Rekruttering
        • Cardiology Associates of West Reading
        • Ta kontakt med:
        • Hovedetterforsker:
          • Earl Hope, MD
      • York, Pennsylvania, Forente stater, 17403
        • Rekruttering
        • WellSpan Heart and Vascular Research
        • Hovedetterforsker:
          • Rhian Davies, MD
        • Ta kontakt med:
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • Rekruttering
        • AnMed Health Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Meehan, MD
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rekruttering
        • Monument Health Clinical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rajesh Pradhan, MD
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • Rekruttering
        • Stern Cardiovascular Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tamunoinemi Bob-Manuel, MD
      • Greeneville, Tennessee, Forente stater, 37745
        • Rekruttering
        • Ballad Health System
        • Hovedetterforsker:
          • Jack Whitaker, MD
        • Ta kontakt med:
      • Jackson, Tennessee, Forente stater, 38305
        • Rekruttering
        • The Jackson Clinic, PA
        • Hovedetterforsker:
          • Shahzad Shah, MD
        • Ta kontakt med:
      • Jackson, Tennessee, Forente stater, 38301
        • Rekruttering
        • Apex Research Foundation, LLC
        • Hovedetterforsker:
          • Mohsin Alhaddad, MD
        • Ta kontakt med:
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • TriStar Centennial Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Huneycutt, MD
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Rekruttering
        • PharmaTex Research
        • Hovedetterforsker:
          • David Brabham, DO
        • Ta kontakt med:
      • Amarillo, Texas, Forente stater, 79124
        • Rekruttering
        • Amarillo Heart Clinical Research Institute, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joaquin Martinez-Arraras, MD
      • Austin, Texas, Forente stater, 78705
        • Rekruttering
        • Austin Heart
        • Hovedetterforsker:
          • Frank Zidar, MD
        • Ta kontakt med:
      • Conroe, Texas, Forente stater, 77384
        • Tilbaketrukket
        • Javara inc.
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Texas Heart Institute
        • Hovedetterforsker:
          • Alexander Postalian, MD
        • Ta kontakt med:
      • Humble, Texas, Forente stater, 77338
        • Rekruttering
        • Vital Heart and Vein
        • Hovedetterforsker:
          • Rick Ganim, MD
        • Ta kontakt med:
      • Kingwood, Texas, Forente stater, 77339
        • Rekruttering
        • Texas Cardiology Associates of Houston
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ira Lieber, MD
      • Lufkin, Texas, Forente stater, 75904
        • Rekruttering
        • Heart Institute of East Texas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ravinder Bachireddy, MD
      • McAllen, Texas, Forente stater, 78504
        • Rekruttering
        • DHR Health Institute for Research
        • Hovedetterforsker:
          • Fiorella Llanos, MD
        • Ta kontakt med:
      • Round Rock, Texas, Forente stater, 78681
        • Rekruttering
        • Austin Heart PLLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joseph Szczytowski, MD
      • San Marcos, Texas, Forente stater, 78666
        • Rekruttering
        • Austin Heart
        • Ta kontakt med:
        • Hovedetterforsker:
          • Faisal Syed, MD
      • Tomball, Texas, Forente stater, 77375
        • Rekruttering
        • Northwest Houston Heart Center
        • Hovedetterforsker:
          • Shamaila Aslam, MD
        • Ta kontakt med:
      • Tomball, Texas, Forente stater, 77375
        • Rekruttering
        • Viva Heart and Vein
        • Ta kontakt med:
        • Hovedetterforsker:
          • Taher Mandviwala, MD
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Rekruttering
        • Intermountain Medical Center
        • Hovedetterforsker:
          • Benjamin Peterson, MD
        • Ta kontakt med:
    • Virginia
      • Newport News, Virginia, Forente stater, 23606
        • Rekruttering
        • TPMG Clinical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Linda Schneider, MD
      • Norfolk, Virginia, Forente stater, 23507
        • Rekruttering
        • Sentara Norfolk General Hospital
        • Hovedetterforsker:
          • David Dexter, MD
        • Ta kontakt med:
      • Richmond, Virginia, Forente stater, 23225
      • Winchester, Virginia, Forente stater, 22601
        • Rekruttering
        • Winchester Cardiology and Vascular Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jeffrey Skiles, MD
    • Washington
      • Puyallup, Washington, Forente stater, 98372
        • Rekruttering
        • MultiCare Institute for Research and Innovation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ahmad Slim, MD
      • Tacoma, Washington, Forente stater, 98405
        • Rekruttering
        • MultiCare Institute for Research and Innovation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Guerra, MD
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54301
        • Rekruttering
        • Bellin Memorial Hospital
        • Hovedetterforsker:
          • Jason Ricci, MD
        • Ta kontakt med:
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Rekruttering
        • Aurora Saint Luke's Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Muhammad Jan, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Inclisiran Sodium

Inclisiran sodium 300 mg subcutaneous injection
Legemiddel: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; & every 6 months thereafter
Placebo komparator: Placebo

Normal saline 1.5 ml subcutaneous injection
Legemiddel: Normal Saline (Placebo)

Normal saline placebo subcutaneous injection given at Day 0, Day 90; & every 6 months thereafter

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
Tidsramme: From randomization to first occurrence of MACE (up to approximately 4 years)

MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.
From randomization to first occurrence of MACE (up to approximately 4 years)
Total number of major adverse limb events (MALE) after endovascular revascularization
Tidsramme: From randomization to first occurrence of MALE (up to approximately 4 years)

MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.
From randomization to first occurrence of MALE (up to approximately 4 years)

Sekundære resultatmål

Resultatmål
Tidsramme
Antall deltakere med kardiovaskulær (CV) død
Tidsramme: Fra randomisering til CV -død (opptil omtrent 4 år)
Fra randomisering til CV -død (opptil omtrent 4 år)
Antall deltakere med alle forårsaker død
Tidsramme: Fra randomisering til all forårsaker død (opptil omtrent 4 år)
Fra randomisering til all forårsaker død (opptil omtrent 4 år)
Antall deltakere med venøs tromboemboliske hendelser (VTE)
Tidsramme: Fra randomisering til første VTE (opptil omtrent 4 år)
Fra randomisering til første VTE (opptil omtrent 4 år)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Samarbeidspartnere

Novartis Pharmaceuticals
Mount Sinai Hospital, New York
Colorado Prevention Center

Etterforskere

  • Studiestol: Manesh Patel, MD, Duke University
  • Hovedetterforsker: Schuyler Jones, MD, Duke Clinical Research Institute
  • Hovedetterforsker: Marc Bonaca, MD, Colorado Prevention Center
  • Studiestol: Roxana Mehran, MD, Mt Sinai

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juli 2025

Primær fullføring (Antatt)

1. oktober 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

27. mars 2025

Først innsendt som oppfylte QC-kriteriene

27. mars 2025

Først lagt ut (Faktiske)

3. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00116826
  • CKJX839D1US04R (Annen identifikator: Novartis Pharmaceuticals Corporation)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere