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Inklisiran versus placebo til forebyggelse af større ugunstige kardiovaskulære og lembegivenheder hos patienter, der gennemgår perkutan koronar intervention eller perifer endovaskulær intervention (V-INTERVENTION)

27. oktober 2026 opdateret af: Duke University

Evaluering af Inclisiran versus placebo til forebyggelse af større bivirkning af kardiovaskulære og lembegivenheder hos patienter, der gennemgår perkutan koronar intervention eller perifer endovaskulær intervention (V-intervention)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

6000

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Inclisiran Sodium

Inclisiran sodium 300 mg subcutaneous injection
Medicin: 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
Medicin: Normal Saline (Placebo)

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Antal deltagere med kardiovaskulær (CV) død
Tidsramme: Fra randomisering til CV -død (op til cirka 4 år)
Fra randomisering til CV -død (op til cirka 4 år)
Antal deltagere med al forårsaget død
Tidsramme: Fra randomisering til al forårsaget død (op til cirka 4 år)
Fra randomisering til al forårsaget død (op til cirka 4 år)
Antal deltagere med venøs tromboemboliske begivenheder (VTE)
Tidsramme: Fra randomisering til første VTE (op til cirka 4 år)
Fra randomisering til første VTE (op til cirka 4 år)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Samarbejdspartnere

Novartis Pharmaceuticals
Mount Sinai Hospital, New York
Colorado Prevention Center

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. juli 2025

Primær færdiggørelse (Anslået)

1. oktober 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

27. marts 2025

Først indsendt, der opfyldte QC-kriterier

27. marts 2025

Først opslået (Faktiske)

3. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner