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.
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
- Conditions the study is for
- Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
- 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.
147 sites in 1 country
United States147 sites, 143 recruiting
- 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
- Withdrawn
Javara inc.
Conroe, Texas, 77384
- Recruiting
Pioneer Clinical Studies
Coral Gables, Florida, 33134
Jeff Somerstein, 305-420-5541, jsomerstein@pioneerstudies.com
Vinod Chainani, MD
- Withdrawn
Valley Clinical Trials
Covina, California, 91723
- Recruiting
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
- Withdrawn
Javara, Inc.
Peachtree City, Georgia, 30269
- Recruiting
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
- Active, not recruiting
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, 34695
- 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
- Recruiting
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614
Allis Delafield, 813-232-0339, adelafieldtcir@gmail.com
Saihari Sadanandan, MD
- Recruiting
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
- Recruiting
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
- Recruiting
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
- Recruiting
Iowa Heart Center
West Des Moines, Iowa, 50266
Cayla Garner, 515-633-3600, cayla.garner@mercyoneiowa.org
Jose Borromeo, MD
- Recruiting
Interventional Cardiology Medical Group
West Hills, California, 91307
Michael Fam, 818-453-6111, mfam@elegantrd.com
Farhad Rafii, MD
- Recruiting
Monroe Research LLC
West Monroe, Louisiana, 71291
Nina Parrott, -318-737-7876, ninaparrottlpncrc@monroeresearch.net
Assad Mouhaffel, MD
- Recruiting
Cardiology Associates of West Reading
West Reading, Pennsylvania, 19611
Mary Alderfer, 610-375-6565, mary.alderfer@towerhealth.org
Earl Hope, MD
- Recruiting
Kansas Nephrology Physicians, PA
Wichita, Kansas, 67214
Angie Anderson, 1-316-262-2045, aanderson@researchmgmt.com
Thomas Ashcom, MD
- Recruiting
Winchester Cardiology and Vascular Medicine
Winchester, Virginia, 22601
Lauren Peterson, 540-536-4399, lpeterso@valleyhealthlink.com
Jeffrey Skiles, MD
- Recruiting
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Jordan Weaver, 1-336-718-6087, jweaver@novanthealth.org
Nizar Noureddine, MD
- Recruiting
WellSpan Heart and Vascular Research
York, Pennsylvania, 17403
Shannon Myers, 1-717-851-3713, smyers22@wellspan.org
Rhian Davies, MD
- Recruiting
Genesis HealthCare System
Zanesville, Ohio, 43701
Carolyn Griffin, 740-455-7640, cgriffin2@genesishcs.org
Abdulhay Albirini, MD
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 group | Role | What they receive |
|---|---|---|
| Inclisiran Sodium | Active comparator | Inclisiran sodium 300 mg subcutaneous injection Receives: Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL |
| Placebo | Placebo comparator | Normal 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.
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)
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)
Number of participants with cardiovascular (CV) death
Measured: From randomization to CV death (up to approximately 4 years)
Number of participants with all cause death
Measured: From randomization to all cause death (up to approximately 4 years)
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.
- First posted3 Apr 2025
- Study start23 Jul 2025
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Colorado Prevention Center, Mount Sinai Hospital, New York
- Responsible party
- Sponsor
- Investigators
- Schuyler Jones, MD, Principal investigator, Duke Clinical Research InstituteMarc Bonaca, MD, Principal investigator, Colorado Prevention CenterRoxana Mehran, MD, Study chair, Mt SinaiManesh Patel, MD, Study chair, Duke University
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 38972336Chamberlain 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