AzTrials
AzTrials

Percutaneous Coronary InterventionPhase 4V-INTERVENTIONNCT06909565

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

A Phase 4 study testing Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL in people with Percutaneous Coronary Intervention and Peripheral Endovascular Intervention, run by Duke University at 147 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,000 participants
Where
147 sitesUnited States
Study dates
23 Jul 2025to Dec 2029
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

147 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robin Barron-Nelson, RN, MSN contact

321-946-2747

robin.barron-nelson@duke.edu

147 sites in 1 country

United States147 sites, 143 recruiting
  • Capital Cardiology Associates

    Albany, New York, 12211

    Shreya Shah, 513-888-1831, sshah@capitalcardiology.com

    Krzysztof Drzymalski, MD

    Recruiting
  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

    Susan Salazar, 1-505-563-2716, ssalazar2@phs.org

    Adam Banks, MD

    Recruiting
  • Advanced Cardiovascular LLC

    Alexander City, Alabama, 35010

    Sabrina Forbus, 256-215-5323, s.forbus.adv@gmail.com

    Brian Foley, MD

    Recruiting
  • PharmaTex Research

    Amarillo, Texas, 79106

    Alexandra Sims, (806) 355-0558, alexandraemuniz@gmail.com

    David Brabham, DO

    Recruiting
  • Amarillo Heart Clinical Research Institute, Inc.

    Amarillo, Texas, 79124

    Susan Nguyen, 806-463-2153, snguyen@amarilloheart.com

    Joaquin Martinez-Arraras, MD

    Recruiting
  • AnMed Health Medical Center

    Anderson, South Carolina, 29621

    Sonya Bair, 1-864-512-8551, sonya.bair@anmed.org

    John Meehan, MD

    Recruiting
  • Asheville Cardiology Associates Research Department

    Asheville, North Carolina, 28803

    Olivia Lim, 828-412-9146, olivia.lim@hcahealthcare.com

    William Pomeroy, MD

    Recruiting
  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Dana Dubas, 1-857-383-8096, dana.dubas@cuanschutz.edu

    Connie Hess, MD

    Recruiting
  • Austin Heart

    Austin, Texas, 78705

    Laura Volz, 512-206-3603, laura.voltz@hcahealthcare.com

    Frank Zidar, MD

    Recruiting
  • IMS Cardiology

    Avondale, Arizona, 85392

    Kristen Sheehan, 602.854.1583, kristen.sheehan@emverahealth.com

    Riyaz Sumar, MD

    Recruiting
  • Northern Light Eastern Maine Medical Center

    Bangor, Maine, 04401

    Tedd Walther, 207-275-3860, twalther@northernlight.org

    Alan Wiseman, MD

    Recruiting
  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Kyle McFadden, 1-989-907-4187, kyle.mcfadden@sluhn.org

    Amit Gupta, MD

    Recruiting
  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

    Victor Guerro, 1-949-284-5715, vguerrero@pacificoaks.com

    Ramprasad Dandillaya, MD

    Recruiting
  • Cardiology, PC

    Birmingham, Alabama, 35211

    Wesley Wade, 205-780-4330, wwade@cardiologypc.com

    Hutton Brantley, MD

    Recruiting
  • Grace Research, LLC

    Bossier City, Louisiana, 71111

    Laurie Hall, 318-638-7309, laurie.hall@graceresearchllc.com

    William Eaves, MD

    Recruiting
  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

    Brenda Garcia, 203-384-4205, brenda.garcia@bpthosp.org

    Edward Tuohy, MD

    Recruiting
  • Advanced Heart Care LLC

    Bridgewater, New Jersey, 08807

    Sivaradhika Yandamuri, 1-908-526-7201, advancedhc2@gmail.com

    Sharan Mahal, MD

    Recruiting
  • Sisters of Charity Hospital

    Buffalo, New York, 14214

    Tatiana Jimenez-Knight, 716-837-2400, tjimenezknight@chsbuffalo.org

    Paul Anain, MD

    Recruiting
  • Trinity Medical WNY, PC

    Buffalo, New York, 14214

    Jalak Upadhyay, 716-305-0139, jupadhyay@trinitymedicalwny.org

    Henry Meltser, MD

    Recruiting
  • Capital Area Research LLC

    Camp Hill, Pennsylvania, 17011

    Alison Singh, 717-963-8389, asingh@care-research.com

    Venkatesh Nadar, MD

    Recruiting
  • Aultman Hospital

    Canton, Ohio, 44710

    Barbara Rambaud, 330-454-8076, barbara.rambaud@aultman.com

    Ramana Podugu, MD

    Recruiting
  • Wellspan Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

    Jacklyn Newman, 717-262-4697, jnewell3@wellspan.org

    Aylmer Tang, MD

    Recruiting
  • Novant Health Clinical Research/Heart & Vascular Institute

    Charlotte, North Carolina, 28204

    Tara Villalta, 704-264-1401, tscaldwell@novanthealth.org

    Daniel Pu, MD

    Recruiting
  • Mecklenburg Heart Specialists

    Charlotte, North Carolina, 28207

    Emad Ghaly, 201-788-1372, eghaly1@gmail.com

    Aamer Qureshi, MD

    Recruiting
  • University of Illinois Chicago

    Chicago, Illinois, 60612

    Yining Chen, 1-312-355-1861, yining@uic.edu

    David Tofovic, MD

    Recruiting
  • Cardiovascular Institute of San Diego

    Chula Vista, California, 91911

    Jacob Pineda, 1-619-616-2100, jacob.pineda@cvisd.com

    Milind Parikh, MD

    Recruiting
  • BayCare Medical Group

    Clearwater, Florida, 33756

    Delia Johnson, 727-462-3578, delia.johnson@baycare.org

    Rakesh Sharma, MD

    Recruiting
  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

    Carolyn Rembish, 727-467-9393 ext. 3117, rembishc@cccheart.com

    Masood Gilani, MD

    Recruiting
  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735

    Wesley McClure, 1-301-877-5583, wesley.mcclure@medstar.net

    Brian Case, MD

    Recruiting
  • University of Missouri Health Care

    Columbia, Missouri, 65212

    Nadine Kallas, 573-882-2296, nkallas@health.missouri.edu

    Albert Chan, MD

    Recruiting
  • John Muir Medical Center - Concord Campus

    Concord, California, 94520

    Rita Trachuk, 1-925-674-2685, rita.trachuk@johnmuirhealth.com

    Bethany Wexler, 1-925-674-2257, bethany.wexler@johnmuirhealth.com

    Recruiting
  • Javara inc.

    Conroe, Texas, 77384

    Withdrawn
  • Pioneer Clinical Studies

    Coral Gables, Florida, 33134

    Jeff Somerstein, 305-420-5541, jsomerstein@pioneerstudies.com

    Vinod Chainani, MD

    Recruiting
  • Valley Clinical Trials

    Covina, California, 91723

    Withdrawn
  • Louisiana Heart Center

    Covington, Louisiana, 70433

    Sherri Dragon, 985-871-4155, s.dragon@laheart.org

    Bruce Iteld, MD

    Recruiting
  • Nuvance Health- Danbury Hospital

    Danbury, Connecticut, 06810

    Danielle Souza, 203-739-7600, danielle.souza@nuvancehealth.org

    Hal Wasserman, MD

    Recruiting
  • Arrow Clinical Trails

    Daytona Beach, Florida, 32117

    Albert Garcia, 386-278-8000, albert@arrowtrials.com

    Charles Ross, MD

    Recruiting
  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

    Lauraine Crandall, 386-310-7462, cardioinc2@aol.com

    Dinesh Arab, MD

    Recruiting
  • Aspirus Saint Luke's Hospital

    Duluth, Minnesota, 55805

    Kayla Walczynski, 218-249-6069, kayla.walczynski@aspirus.org

    Scott Mikesell, MD

    Recruiting
  • Essentia Health-SMMC

    Duluth, Minnesota, 55805

    Haley Messenger, 218-786-7964, haley.messenger@essentiahealth.org

    Catherine Benziger, MD

    Recruiting
  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

    Julie Large, 574-522-0337, jlarge@beaconhealthsystem.org

    Troy Weirick, MD

    Recruiting
  • Cardiovascular Associates of the Delaware Valley

    Elmer, New Jersey, 08318

    Traci Vogt, 856-358-8125, tvogt@hearthousenj.com

    Mark Gelernt, MD

    Recruiting
  • Aurora Denver Cardiology Associates - Englewood

    Englewood, Colorado, 80113

    Rylee Funkhouser, 1-720-990-8071, rylee.funkhouser@hcahealthcare.com

    Ehrin Armstrong, MD

    Recruiting
  • Javara Inc.

    Fayetteville, North Carolina, 28304

    Shannon Casey, 1-312-363-8017, shannon.casey@javararesearch.com

    Amol Bakekar, MD

    Recruiting
  • Advanced Heart and Vascular Institute Of Hunterdon

    Flemington, New Jersey, 08822

    Alexis Bellafiore, 908-291-3405, abellafiore@ahvi-nj.com

    Andrey Espinoza, MD

    Recruiting
  • Northeast Georgia Heart Center, PC

    Gainesville, Georgia, 30501

    Donna Patrick, 678-989-5001, donna.patrick@nghs.com

    Nima Ghasemzadeh, MD

    Recruiting
  • Stern Cardiovascular Center

    Germantown, Tennessee, 38138

    Nakia Proge, 901-271-4164, nakia.proge@sterncardio.com

    Tamunoinemi Bob-Manuel, MD

    Recruiting
  • Thrive Clinical Research Group

    Glendora, California, 91740

    Tayler Flores, 1-626-823-7095, tflores@thriveclinicalresearch.org

    Fahed Bitar, MD

    Recruiting
  • CHI Health Nebraska Heart

    Grand Island, Nebraska, 68803

    Melissa Kelley, 308-381-8636, melissa.kelley@commonspirit.org

    Douglas Kosmicki, MD

    Recruiting
  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

    Katherine Guilliams, 1-920-617-2060, katherine.guilliams@emplifyhealth.org

    Jason Ricci, MD

    Recruiting
  • Ballad Health System

    Greeneville, Tennessee, 37745

    Tammy Dicken, 1-423-262-4473, tammy.dicken@balladhealth.org

    Jack Whitaker, MD

    Recruiting
  • Moses H Cone Memorial Hospital

    Greensboro, North Carolina, 27401

    Heather Mcghee, 1-336-832-3799, heather.mcghee@conehealth.com

    Muhammad Arida, MD

    Recruiting
  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

    Kaitlyn Downey, 856-546-3003 ext. 3262, kdowney@hearthousenj.com

    Sanford Gips, MD

    Recruiting
  • Wake Forest University Health Sciences

    High Point, North Carolina, 27262

    Lisa Wilkerson, 1-336-885-6168, lisa.wilkerson@advocatehealth.org

    H. Barrett Cheek, MD

    Recruiting
  • Texas Heart Institute

    Houston, Texas, 77030

    Sylvia Carranza, 1-832-355-8524, sylvia.carranza@bcm.edu

    Alexander Postalian, MD

    Recruiting
  • Vital Heart and Vein

    Humble, Texas, 77338

    Syed Zaidi, 1-281-572-0078, syed.zaidi@vitalheartandvein.com

    Rick Ganim, MD

    Recruiting
  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

    Cynthia Abath, 256-519-8235, cabath@theheartcenter.md

    Henry Chen, MD

    Recruiting
  • Apex Research Foundation, LLC

    Jackson, Tennessee, 38301

    Pam Gibbons, (731)423-8200, pgibbons@researchjackson.com

    Mohsin Alhaddad, MD

    Recruiting
  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

    Felecia Bruton, 1-731-660-8444, fbruton@jacksonclinic.com

    Shahzad Shah, MD

    Recruiting
  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Kailyn Herndon, 1-904-244-8232, kailyn.herndon@ufhealth.org

    Francesco Franchi, MD

    Recruiting
  • First Coast Cardiovascular Institute, PA

    Jacksonville, Florida, 32256

    Alayna Socia, 1-904-718-5787, asocia@firstcoastcardio.com

    Yazan Khatib, MD

    Recruiting
  • Cardiology Associates Research Group

    Jonesboro, Arkansas, 72401

    Beth Morgan, 1-870-207-3812, bmorgan@cargresearch.com

    Ahmed Ahmed, MD

    Recruiting
  • Texas Cardiology Associates of Houston

    Kingwood, Texas, 77339

    Fielicia Stowe, 832-644-5372, fielicia.stowe@tcrinstitute.com

    Ira Lieber, MD

    Recruiting
  • Penn Lancaster General Health Research Institute

    Lancaster, Pennsylvania, 17602

    Ann Marie Blair, annmarie.blair@pennmedicine.upenn.edu

    Jian Shan, MD

    Recruiting
  • Capitol Cardiology Associates PA

    Lanham, Maryland, 20706

    Iluyomade Adeusi, 301-312-0575, iluyomade@capitolcardiology.com

    Vivek Bahl, MD

    Recruiting
  • UMH-Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

    Lonna Blaske, 517-364-5115, lonna.blaske@umhsparrow.org

    Chad Link, MD

    Recruiting
  • Clearwater Cardiovascular and Interventional Consultants- Bardmoor

    Largo, Florida, 33777

    Teresa Jones, 727-467-9393, jonest@cccheart.com

    Alexander Heckman, MD

    Recruiting
  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Pauline Sirrell, 603-650-4638, pauline.sirrell@hitchcock.org

    Jocelyn Beach, MD

    Recruiting
  • Bryan Heart

    Lincoln, Nebraska, 68506

    Nicci Thompson, 402-483-3290, nicci.thompson@bryanheart.com

    Rajeev Anchan, MD

    Recruiting
  • CHI Health Nebraska Heart

    Lincoln, Nebraska, 68526

    Julie Potter, 402-328-3946, jpotter@commonspirit.org

    Anuradha Tunuguntla, MD

    Recruiting
  • Arkansas Cardiology

    Little Rock, Arkansas, 72205

    Bobbi Phillips, 501-227-7596, bphillips@arcard.org

    David Jones, MD

    Recruiting
  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

    Leybi Ramirez-Kelly, 1-501-978-3736, leybi.ramirez-kelly@arheart.com

    Ian Cawich, MD

    Recruiting
  • Heart Institute of East Texas

    Lufkin, Texas, 75904

    Azeez Lawal, 1-936-249-6489, azeez.lawal@sitebridgeresearch.com

    Ravinder Bachireddy, MD

    Recruiting
  • JAVARA Inc, - Mankato Clinic

    Mankato, Minnesota, 56001

    Chelsea Morning, 507-216-0972, chelsea.morning@javararesearch.com

    Manpreet Kanwar, MD

    Recruiting
  • DHR Health Institute for Research

    McAllen, Texas, 78504

    Clarisa Medina, 1-956-362-2398, c.medina@dhrhealth.com

    Fiorella Llanos, MD

    Recruiting
  • Heart Center of Lake County

    Merrillville, Indiana, 46410

    Kimberly Armstrong, (219) 884-9180, theheartcenterlcka@yahoo.com

    Andre Artis, MD

    Recruiting
  • Inpatient Research Clinic, LLC

    Miami Lakes, Florida, 33014

    Dora Gutierrez, 786-502-4303, dgutierrez@inpatientresearch.com

    Francisco Dieguez Jr, MD

    Recruiting
  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670

    Jamie Prior, 989-631-2469, jamie.prior@mymichigan.org

    William Felten, MD

    Recruiting
  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Sara Klein, 1-414-385-2475, sara.klein@aah.org

    Muhammad Jan, MD

    Recruiting
  • Duke Cardiology

    Morrisville, North Carolina, 27560

    Erin Campo, (919) 668-0927, erin.campo@duke.edu

    Schuyler Jones, MD

    Recruiting
  • Intermountain Medical Center

    Murray, Utah, 84107

    Tyler Winslow, 1-617-987-1046, tyler.winslow@imail.org

    Benjamin Peterson, MD

    Recruiting
  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Michael Brown, 1-615-426-9609, michael.brown@hcahealthcare.com

    David Huneycutt, MD

    Recruiting
  • Tulane School of Medicine

    New Orleans, Louisiana, 70112

    Neda Khoshkhoo, 504-988-9809, nkhoshkhoo@tulane.edu

    Anand Irimpen, MD

    Recruiting
  • Mount Sinai School of Medicine

    New York, New York, 10029

    Chivelle Mendoza, 1-212-241-7052, chivelle.mendoza@mountsinai.org

    Prakash Krishnan, MD

    Recruiting
  • Radin Cardiovascular Medical Group, Inc

    Newport Beach, California, 92663

    Morgan Stoaks, 1-949-722-7555, morgan.rcmg@gmail.com

    Michael Radin, MD

    Recruiting
  • TPMG Clinical Research

    Newport News, Virginia, 23606

    Heather Freeman, 757-232-8836, heather.freeman@tpmgpc.com

    Linda Schneider, MD

    Recruiting
  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Angela Zahn, 1-757-388-4028, axzahn@sentara.com

    David Dexter, MD

    Recruiting
  • Amicis Research

    Northridge, California, 91324

    Srilakshmi Daggula, 1-818-924-4708, s.daggula@amicisresearch.com

    Heather Shenkman, MD

    Recruiting
  • Valley Clinical Trials, LLC - Flourish Research

    Northridge, California, 91325

    Monica Brown, 818-280-4220, mbrown@flourishresearch.com

    Mehrdad Ariani, MD

    Recruiting
  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

    Rachel Burgan, 405-628-6865, rburgan@okheart.com

    Naeem Tahirkheli, MD

    Recruiting
  • Methodist Physicians Clinic Heart Consultants

    Omaha, Nebraska, 68114

    Dru McMartin, 402-354-0350, dru.mcmartin@nmhs.org

    William Nester, MD

    Recruiting
  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

    Madelyn Cheadle, 913-253-3069, madelyn.cheadle@hcahealthcare.com

    Stephen Bloom, MD

    Recruiting
  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

    Aayushi Pasad, 270-691-1827, aapa1451@drvora.com

    Kishor Vora, MD

    Recruiting
  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405

    Shelley Sherk, 505-918-7057, ssherk@cvinwfl.com

    Amir Haghighat, MD

    Recruiting
  • Gulf Coast Heart and Vascular

    Panama City, Florida, 32405

    Annie Salvarrey, 1-850-737-0487, asalvarrey@gchvfl.com

    Ajay Labroo, MD

    Recruiting
  • Advocate Aurora Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Stacey Pahlke, 1-847-723-5279, stacey.pahlke@aah.org

    Nishant Patel, MD

    Recruiting
  • Javara, Inc.

    Peachtree City, Georgia, 30269

    Withdrawn
  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

    Jackie White, 1-609-404-7654, jmwhite@atlanticare.org

    Sanjay Shetty, MD

    Recruiting
  • Trinity Health Oakland Hospital

    Pontiac, Michigan, 48341

    Jenny Romlein, 1-248-858-3911, jenny.romlein@trinity-health.org

    Abdul-Rahman Halabi

    Recruiting
  • Charlotte Heart & Vascular Center, PA

    Port Charlotte, Florida, 33948

    Hanna Bishop, 941-286-7294, hannabishop@charlotteheart.net

    Mario Lopez, MD

    Recruiting
  • Hudson Valley Cardiovascular Practice PC

    Poughkeepsie, New York, 12601

    Muskaan Ochani, 845-473-1188, muskaan.ochani@nuvancehealth.org

    Sunny Intwala, MD

    Recruiting
  • MultiCare Institute for Research and Innovation

    Puyallup, Washington, 98372

    Fawna White, 253-697-4192, fawna.white@multicare.org

    Ahmad Slim, MD

    Recruiting
  • Duke Vascular Surgery and Vein Center at Brier Creek

    Raleigh, North Carolina, 27617

    Frank Benedetti, 919-684-3381, frank.benedetti@duke.edu

    E. Hope Weissler, MD

    Recruiting
  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

    Amber Odegard, 1-605-755-4326, aodegard@regionalhealth.org

    Rajesh Pradhan, MD

    Recruiting
  • Reid Physician Associates

    Richmond, Indiana, 47374

    Kristi McGuire, 1-765-935-8792, kristi.mcguire@reidhealth.org

    John McGinty, MD

    Recruiting
  • Chippenham Hospital

    Richmond, Virginia, 23225

    Casey Garrett, 804-548-5296, elizabeth.garrett@hcahealthcare.com

    Nayef Abouzaki, MD

    Recruiting
  • Riverside Community Hospital

    Riverside, California, 92501

    Breanna Silesky, 951-314-4907, breanne.silesky@hcahealthcare.com

    Patrick Hu, MD

    Recruiting
  • University of Rochester Medical Center

    Rochester, New York, 14642

    Cassidy Gross, 585-276-0150, cassidy_gross@urmc.rochester.edu

    Jeffery Bruckel, MD

    Recruiting
  • Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates

    Rochester Hills, Michigan, 48307

    Eveit Toma, 586-275-9285, eveittoma@gmail.com

    Sandeep Khurana, MD

    Recruiting
  • OSF HealthCare Cardiovascular Institute

    Rockford, Illinois, 61107

    Barbara Connors, 1-815-847-5831, barbara.l.connors@osfhealthcare.org

    Montoya Taylor, MD

    Recruiting
  • Shady Grove Adventist Hospital

    Rockville, Maryland, 20850

    Shilpa Rele, 240-826-6167, srele@adventisthealthcare.com

    Bryan White, MD

    Recruiting
  • Austin Heart PLLC

    Round Rock, Texas, 78681

    Teresa Shipwash, 512-341-3959, teresa.shipwash@hcahealthcare.com

    Joseph Szczytowski, MD

    Recruiting
  • Clearwater Cardiovascular Consultants

    Safety Harbor, Florida, 34695

    Active, not recruiting
  • TidalHealth Peninsula Regional

    Salisbury, Maryland, 21804

    Theresa Hahn, 1-410-912-6122, theresa.hahn@tidalhealth.org

    Steven Hearne, MD

    Recruiting
  • Kaiser Permanente - San Diego

    San Diego, California, 92123

    Michael Fechter, 1-858-266-6604, michael.d.fechter@kp.org

    Bahram Khadivi, MD

    Recruiting
  • San Diego Cardiac Center

    San Diego, California, 92123

    Donna Small, 858-244-6800, dsmall@sdcardiac.com

    Jiken Bhatt, MD

    Recruiting
  • Sutter Health Heart and Vascular

    San Francisco, California, 94109

    Milena Ferreira, 415-600-5707, milena.ferreira@sutterhealth.org

    Hernan Bazan, MD

    Recruiting
  • Austin Heart

    San Marcos, Texas, 78666

    Leticia Janak, 512-216-6502, leticia.janak@hcahealthcare.com

    Faisal Syed, MD

    Recruiting
  • Cardiovascular Associates of the Delaware Valley

    Sewell, New Jersey, 08080

    Sue Manga, 856-582-2000 ext. 5281, smanga@hearthousenj.com

    Dilip Viswanath, MD

    Recruiting
  • Cardiovascular Solutions, LLC

    Shreveport, Louisiana, 71103

    Elisha Strahan, 318-638-7214, ebagley.cvsolutions@gmail.com

    Wenwu Zhang, MD

    Recruiting
  • Jadestone Clinical Research, LLC

    Silver Spring, Maryland, 20904

    Lisa Nguyen, 240-429-4337, lisa.nguyen@jadestonecr.com

    Homan Ibrahim, MD

    Recruiting
  • Stern Cardiovascular

    Southaven, Mississippi, 38671

    Meshun Briscoe, 901-271-1000, meshun.briscoe@sterncardio.com

    Dharmesh Patel, MD

    Recruiting
  • Heart House Research Foundation LLC

    Springfield, Ohio, 45505

    Kylie Hubbard, 937-523-9545, khubbard3@mercy.com

    Mian Bilal Alam, MD

    Recruiting
  • Cardiology Associates of Fairfield County

    Stamford, Connecticut, 06305

    Lauren Rivera, 203-246-9994, lrivera@cafconline.com

    Viktoria Klymenko, 754-364-8485, vklymenko@cafconline.com

    Recruiting
  • Richmond University Medical Center

    Staten Island, New York, 10310

    Christian Ponce Garcia, 1-718-818-2707, chrgarcia@rumcsi.org

    Francesco Rotatori, MD

    Recruiting
  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405

    Trina Wesner, 253-403-7449, trina.wesner@multicare.org

    Daniel Guerra, MD

    Recruiting
  • Washington Vascular Specialists - ClinRe 001-136

    Takoma Park, Maryland, 20912

    Saad Syed, 1-571-685-3551, ssyedl@clinre.com

    Mubashar Choudry, MD

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  • Tampa Cardiovascular Interventions and Research

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    Allis Delafield, 813-232-0339, adelafieldtcir@gmail.com

    Saihari Sadanandan, MD

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  • Jacobi Medical Center

    The Bronx, New York, 10461

    Cidney Schultz, 1-718-918-6212, cidney.schultz@nychhc.org

    Usman Khan, MD

    Recruiting
  • ClinRe 001-001

    Thornton, Colorado, 80023

    Salman Gondal, 1-720-772-8040, sgondal@clinre.com

    Rajesh Sharma, MD

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  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

    Abeer Abu-Saif, 1-419-842-3000, abeer.abu-saif@promedica.org

    Mujeeb Sheikh, MD

    Recruiting
  • Northwest Houston Heart Center

    Tomball, Texas, 77375

    Dawn Burns, 281-351-4911, dburns@houstonheartcenter.com

    Shamaila Aslam, MD

    Recruiting
  • Viva Heart and Vein

    Tomball, Texas, 77375

    Elizabeth Martin, 832-364-0851, emartinresearch@gmail.com

    Taher Mandviwala, MD

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  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

    Olga Barillas, 323-457-1933, olga@lundquist.org

    Quang Bui, MD

    Recruiting
  • Atlanta Heart Specialists LLC

    Tucker, Georgia, 30084

    Hiwot Haile, 770-407-6369, hhaile@ahsmed.com

    David Suh, MD

    Recruiting
  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

    Kristin Eads, 662-377-3000, keads@nmhs.net

    Richard Ballard, MD

    Recruiting
  • The Heart Medical Group

    Van Nuys, California, 91406

    Monica Brown, 818-280-4220, mbrown@flourishresearch.com

    Munaf Shamji, MD

    Recruiting
  • FOMAT - West Coast Research Center

    Ventura, California, 93030

    Thai Orantes, 805-483-1185 ext. 839, torantes@fomatmedical.com

    David Blitzer, MD

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  • Iowa Heart Center

    West Des Moines, Iowa, 50266

    Cayla Garner, 515-633-3600, cayla.garner@mercyoneiowa.org

    Jose Borromeo, MD

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  • Interventional Cardiology Medical Group

    West Hills, California, 91307

    Michael Fam, 818-453-6111, mfam@elegantrd.com

    Farhad Rafii, MD

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  • Monroe Research LLC

    West Monroe, Louisiana, 71291

    Nina Parrott, -318-737-7876, ninaparrottlpncrc@monroeresearch.net

    Assad Mouhaffel, MD

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    West Reading, Pennsylvania, 19611

    Mary Alderfer, 610-375-6565, mary.alderfer@towerhealth.org

    Earl Hope, MD

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  • Kansas Nephrology Physicians, PA

    Wichita, Kansas, 67214

    Angie Anderson, 1-316-262-2045, aanderson@researchmgmt.com

    Thomas Ashcom, MD

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    Winchester, Virginia, 22601

    Lauren Peterson, 540-536-4399, lpeterso@valleyhealthlink.com

    Jeffrey Skiles, MD

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    Rhian Davies, MD

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    Carolyn Griffin, 740-455-7640, cgriffin2@genesishcs.org

    Abdulhay Albirini, MD

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

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.

Read the detailed description

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.

Being tested
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Normal Saline (Placebo)
Keywords
inclisiran, Coronary Artery Disease, hypercholesterolemia, Cardiovascular Disease, Percutaneous Endovascular Intervention, Percutaneous Coronary Intervention, PCSK9
Medical subject headings
Coronary Artery Disease, Hypercholesterolemia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLDrug

    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

Study groups in NCT06909565
Study groupRoleWhat they receive
Inclisiran SodiumActive comparatorInclisiran sodium 300 mg subcutaneous injection
Receives: Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
PlaceboPlacebo comparatorNormal saline 1.5 ml subcutaneous injection
Receives: Drug: Normal Saline (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization

    MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.

    Measured: From randomization to first occurrence of MACE (up to approximately 4 years)

  2. Total number of major adverse limb events (MALE) after endovascular revascularization

    MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.

    Measured: From randomization to first occurrence of MALE (up to approximately 4 years)

Secondary outcomes (3)
  1. Number of participants with cardiovascular (CV) death

    Measured: From randomization to CV death (up to approximately 4 years)

  2. Number of participants with all cause death

    Measured: From randomization to all cause death (up to approximately 4 years)

  3. Number of participants with venous thromboembolic events (VTE)

    Measured: From randomization to first VTE (up to approximately 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start23 Jul 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909565
Sponsor's protocol ID
Pro00116826
Other IDs
CKJX839D1US04R
Acronym
V-INTERVENTION
Status last verified
Jul 2026
First submitted
27 Mar 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Navar AM, Shah NP, Shrader P, Thomas LE, Ahmad Z, Allred C, Chamberlain AM, Chrischilles EA, Dhalwani N, Effron MB, Hayek S, Jones LK, Kalich B, Shapiro MD, Wojcik C, Peterson ED. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025 Jan;279:107-117. doi: 10.1016/j.ahj.2024.06.012. Epub 2024 Jul 6.

    PubMed 38972336
  • Chamberlain AM, Gong Y, Shaw KM, Bian J, Song WL, Linton MF, Fonseca V, Price-Haywood E, Guhl E, King JB, Shah RU, Puro J, Shenkman E, Pawloski PA, Margolis KL, Hernandez AF, Cooper-DeHoff RM. PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network. J Am Heart Assoc. 2019 May 7;8(9):e011246. doi: 10.1161/JAHA.118.011246.

    PubMed 31020929

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