Sponsor:
Duke University
Code:
NCT06909565
Conditions
Percutaneous Coronary Intervention
Peripheral Endovascular Intervention
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Normal Saline (Placebo)
Brief summary:
Conditions
Percutaneous Coronary Intervention
Peripheral Endovascular Intervention
Study ID
NCT06909565
Start date
Jul 23, 2025
Status verified date
Jul, 2026
Completion date
Dec, 2029
Anticipated
Primary completion date
Oct, 2029
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
6000 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Prevention
Arms
active comparator: Inclisiran Sodium
placebo comparator: Placebo
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Normal Saline (Placebo)
Primary outcome measure
Central contacts
Locations
Advanced Cardiovascular LLC
Recruiting
Alexander City, Alabama, United States, 35010
Contacts
Principal Investigator:
Brian Foley, MD
Cardiology, PC
Recruiting
Birmingham, Alabama, United States, 35211
Contacts
Principal Investigator:
Hutton Brantley, MD
Heart Center Research, LLC
Recruiting
Huntsville, Alabama, United States, 35801
Contacts
Principal Investigator:
Henry Chen, MD
IMS Cardiology
Recruiting
Avondale, Arizona, United States, 85392
Contacts
Principal Investigator:
Riyaz Sumar, MD
Cardiology Associates Research Group
Recruiting
Jonesboro, Arkansas, United States, 72401
Contacts
Principal Investigator:
Ahmed Ahmed, MD
Arkansas Cardiology
Recruiting
Little Rock, Arkansas, United States, 72205
Contacts
Principal Investigator:
David Jones, MD
Pacific Oaks Medical Group
Recruiting
Beverly Hills, California, United States, 90211
Contacts
Principal Investigator:
Ramprasad Dandillaya, MD
Cardiovascular Institute of San Diego
Recruiting
Chula Vista, California, United States, 91911
Contacts
Principal Investigator:
Milind Parikh, MD
John Muir Medical Center - Concord Campus
Recruiting
Concord, California, United States, 94520
Contacts
Principal Investigator:
Jason Liu, MD
Thrive Clinical Research Group
Recruiting
Glendora, California, United States, 91740
Contacts
Principal Investigator:
Fahed Bitar, MD
Radin Cardiovascular Medical Group, Inc
Recruiting
Newport Beach, California, United States, 92663
Contacts
Principal Investigator:
Michael Radin, MD
Valley Clinical Trials, LLC - Flourish Research
Recruiting
Northridge, California, United States, 91325
Contacts
Principal Investigator:
Mehrdad Ariani, MD
Riverside Community Hospital
Recruiting
Riverside, California, United States, 92501
Contacts
Principal Investigator:
Patrick Hu, MD
Kaiser Permanente - San Diego
Recruiting
San Diego, California, United States, 92123
Contacts
Principal Investigator:
Bahram Khadivi, MD
San Diego Cardiac Center
Recruiting
San Diego, California, United States, 92123
Contacts
Principal Investigator:
Jiken Bhatt, MD
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Recruiting
Torrance, California, United States, 90502
Contacts
Principal Investigator:
Quang Bui, MD
The Heart Medical Group
Recruiting
Van Nuys, California, United States, 91406
Contacts
Principal Investigator:
Munaf Shamji, MD
FOMAT - West Coast Research Center
Recruiting
Ventura, California, United States, 93030
Contacts
Principal Investigator:
David Blitzer, MD
Interventional Cardiology Medical Group
Recruiting
West Hills, California, United States, 91307
Contacts
Principal Investigator:
Farhad Rafii, MD
University of Colorado Anschutz Medical Campus
Recruiting
Aurora, Colorado, United States, 80045
Contacts
Principal Investigator:
Connie Hess, MD
Aurora Denver Cardiology Associates - Englewood
Recruiting
Englewood, Colorado, United States, 80113
Contacts
Principal Investigator:
Ehrin Armstrong, MD
ClinRe 001-001
Recruiting
Thornton, Colorado, United States, 80023
Contacts
Principal Investigator:
Rajesh Sharma, MD
Bridgeport Hospital
Recruiting
Bridgeport, Connecticut, United States, 06610
Contacts
Principal Investigator:
Edward Tuohy, MD
Nuvance Health- Danbury Hospital
Recruiting
Danbury, Connecticut, United States, 06810
Contacts
Principal Investigator:
Hal Wasserman, MD
Cardiology Associates of Fairfield County
Recruiting
Stamford, Connecticut, United States, 06305
Contacts
Principal Investigator:
Edward Portnay, MD
BayCare Medical Group
Recruiting
Clearwater, Florida, United States, 33756
Contacts
Principal Investigator:
Rakesh Sharma, MD
Clearwater Cardiovascular Consultants
Recruiting
Clearwater, Florida, United States, 33756
Contacts
Principal Investigator:
Masood Gilani, MD
Pioneer Clinical Studies
Recruiting
Coral Gables, Florida, United States, 33134
Contacts
Principal Investigator:
Vinod Chainani, MD
Arrow Clinical Trails
Recruiting
Daytona Beach, Florida, United States, 32117
Contacts
Principal Investigator:
Charles Ross, MD
UF Health Jacksonville
Recruiting
Jacksonville, Florida, United States, 32209
Contacts
Principal Investigator:
Francesco Franchi, MD
First Coast Cardiovascular Institute, PA
Recruiting
Jacksonville, Florida, United States, 32256
Contacts
Principal Investigator:
Yazan Khatib, MD
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Recruiting
Largo, Florida, United States, 33777
Contacts
Principal Investigator:
Alexander Heckman, MD
Inpatient Research Clinic, LLC
Recruiting
Miami Lakes, Florida, United States, 33014
Contacts
Principal Investigator:
Francisco Dieguez Jr, MD
Cardiovascular Institute of Northwest Florida
Recruiting
Panama City, Florida, United States, 32405
Contacts
Principal Investigator:
Amir Haghighat, MD
Gulf Coast Heart and Vascular
Recruiting
Panama City, Florida, United States, 32405
Contacts
Principal Investigator:
Ajay Labroo, MD
Charlotte Heart & Vascular Center, PA
Recruiting
Port Charlotte, Florida, United States, 33948
Contacts
Principal Investigator:
Mario Lopez, MD
Tampa Cardiovascular Interventions and Research
Recruiting
Tampa, Florida, United States, 33614
Contacts
Principal Investigator:
Saihari Sadanandan, MD
Northeast Georgia Heart Center, PC
Recruiting
Gainesville, Georgia, United States, 30501
Contacts
Principal Investigator:
Nima Ghasemzadeh, MD
Atlanta Heart Specialists LLC
Recruiting
Tucker, Georgia, United States, 30084
Contacts
Principal Investigator:
David Suh, MD
University of Illinois Chicago
Recruiting
Chicago, Illinois, United States, 60612
Contacts
Principal Investigator:
David Tofovic, MD
Advocate Aurora Lutheran General Hospital
Recruiting
Park Ridge, Illinois, United States, 60068
Contacts
Principal Investigator:
Nishant Patel, MD
Midwest Cardiovascular Research and Education Foundation
Recruiting
Elkhart, Indiana, United States, 46514
Contacts
Principal Investigator:
Troy Weirick, MD
Heart Center of Lake County
Recruiting
Merrillville, Indiana, United States, 46410
Contacts
Principal Investigator:
Andre Artis, MD
Reid Physician Associates
Recruiting
Richmond, Indiana, United States, 47374
Contacts
Principal Investigator:
John McGinty, MD
Iowa Heart Center
Recruiting
West Des Moines, Iowa, United States, 50266
Contacts
Principal Investigator:
Jose Borromeo, MD
Midwest Heart and Vascular Specialists
Recruiting
Overland Park, Kansas, United States, 66211
Contacts
Principal Investigator:
Stephen Bloom, MD
Research Integrity, LLC
Recruiting
Owensboro, Kentucky, United States, 42303
Contacts
Principal Investigator:
Kishor Vora, MD
Grace Research, LLC
Recruiting
Bossier City, Louisiana, United States, 71111
Contacts
Principal Investigator:
William Eaves, MD
Louisiana Heart Center
Recruiting
Covington, Louisiana, United States, 70433
Contacts
Principal Investigator:
Bruce Iteld, MD
Tulane School of Medicine
Recruiting
New Orleans, Louisiana, United States, 70112
Contacts
Principal Investigator:
Anand Irimpen, MD
Cardiovascular Solutions, LLC
Recruiting
Shreveport, Louisiana, United States, 71103
Contacts
Principal Investigator:
Wenwu Zhang, MD
Monroe Research LLC
Recruiting
West Monroe, Louisiana, United States, 71291
Contacts
Principal Investigator:
Assad Mouhaffel, MD
Northern Light Eastern Maine Medical Center
Recruiting
Bangor, Maine, United States, 04401
Contacts
Principal Investigator:
Alan Wiseman, MD
MedStar Southern Maryland Hospital Center
Recruiting
Clinton, Maryland, United States, 20735
Contacts
Principal Investigator:
Brian Case, MD
Capitol Cardiology Associates PA
Recruiting
Lanham, Maryland, United States, 20706
Contacts
Principal Investigator:
Vivek Bahl, MD
Shady Grove Adventist Hospital
Recruiting
Rockville, Maryland, United States, 20850
Contacts
Principal Investigator:
Bryan White, MD
TidalHealth Peninsula Regional
Recruiting
Salisbury, Maryland, United States, 21804
Contacts
Principal Investigator:
Steven Hearne, MD
Jadestone Clinical Research, LLC
Recruiting
Silver Spring, Maryland, United States, 20904
Contacts
Principal Investigator:
Homan Ibrahim, MD
Washington Vascular Specialists - ClinRe 001-136
Recruiting
Takoma Park, Maryland, United States, 20912
Contacts
Principal Investigator:
Mubashar Choudry, MD
UMH-Sparrow Clinical Research Institute
Recruiting
Lansing, Michigan, United States, 48912
Contacts
Principal Investigator:
Chad Link, MD
MyMichigan Medical Center Midland
Recruiting
Midland, Michigan, United States, 48670
Contacts
Principal Investigator:
William Felten, MD
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
Recruiting
Rochester Hills, Michigan, United States, 48307
Contacts
Principal Investigator:
Sandeep Khurana, MD
Aspirus Saint Luke's Hospital
Recruiting
Duluth, Minnesota, United States, 55805
Contacts
Principal Investigator:
Scott Mikesell, MD
Essentia Health-SMMC
Recruiting
Duluth, Minnesota, United States, 55805
Contacts
Principal Investigator:
Catherine Benziger, MD
JAVARA Inc, - Mankato Clinic
Recruiting
Mankato, Minnesota, United States, 56001
Contacts
Principal Investigator:
Manpreet Kanwar, MD
Stern Cardiovascular
Recruiting
Southaven, Mississippi, United States, 38671
Contacts
Principal Investigator:
Dharmesh Patel, MD
Cardiology Associates of North Mississippi
Recruiting
Tupelo, Mississippi, United States, 38801
Contacts
Principal Investigator:
Richard Ballard, MD
University of Missouri Health Care
Recruiting
Columbia, Missouri, United States, 65212
Contacts
Principal Investigator:
Albert Chan, MD
CHI Health Nebraska Heart
Recruiting
Grand Island, Nebraska, United States, 68803
Contacts
Principal Investigator:
Douglas Kosmicki, MD
Bryan Heart
Recruiting
Lincoln, Nebraska, United States, 68506
Contacts
Principal Investigator:
Rajeev Anchan, MD
CHI Health Nebraska Heart
Recruiting
Lincoln, Nebraska, United States, 68526
Contacts
Principal Investigator:
Anuradha Tunuguntla, MD
Methodist Physicians Clinic Heart Consultants
Recruiting
Omaha, Nebraska, United States, 68114
Contacts
Principal Investigator:
William Nester, MD
Dartmouth-Hitchcock Medical Center
Recruiting
Lebanon, New Hampshire, United States, 03756
Contacts
Principal Investigator:
Jocelyn Beach, MD
Advanced Heart Care LLC
Recruiting
Bridgewater, New Jersey, United States, 08807
Contacts
Principal Investigator:
Sharan Mahal, MD
Cardiovascular Associates of the Delaware Valley
Recruiting
Elmer, New Jersey, United States, 08318
Contacts
Principal Investigator:
Mark Gelernt, MD
Advanced Heart and Vascular Institute Of Hunterdon
Recruiting
Flemington, New Jersey, United States, 08822
Contacts
Principal Investigator:
Andrey Espinoza, MD
Cardiovascular Associates of the Delaware Valley
Recruiting
Haddon Heights, New Jersey, United States, 08035
Contacts
Principal Investigator:
Sanford Gips, MD
AtlantiCare Regional Medical Center
Recruiting
Pomona, New Jersey, United States, 08240
Contacts
Principal Investigator:
Sanjay Shetty, MD
Cardiovascular Associates of the Delaware Valley
Recruiting
Sewell, New Jersey, United States, 08080
Contacts
Principal Investigator:
Dilip Viswanath, MD
Presbyterian Heart Group
Recruiting
Albuquerque, New Mexico, United States, 87106
Contacts
Principal Investigator:
Adam Banks, MD
Capital Cardiology Associates
Recruiting
Albany, New York, United States, 12211
Contacts
Principal Investigator:
Krzysztof Drzymalski, MD
Sisters of Charity Hospital
Recruiting
Buffalo, New York, United States, 14214
Contacts
Principal Investigator:
Paul Anain, MD
Trinity Medical WNY, PC
Recruiting
Buffalo, New York, United States, 14214
Contacts
Principal Investigator:
Henry Meltser, MD
Mount Sinai School of Medicine
Recruiting
New York, New York, United States, 10029
Contacts
Principal Investigator:
Prakash Krishnan, MD
Hudson Valley Cardiovascular Practice PC
Recruiting
Poughkeepsie, New York, United States, 12601
Contacts
Principal Investigator:
Sunny Intwala, MD
University of Rochester Medical Center
Recruiting
Rochester, New York, United States, 14642
Contacts
Principal Investigator:
Jeffery Bruckel, MD
Richmond University Medical Center
Recruiting
Staten Island, New York, United States, 10310
Contacts
Principal Investigator:
Francesco Rotatori, MD
Jacobi Medical Center
Recruiting
The Bronx, New York, United States, 10461
Contacts
Principal Investigator:
Usman Khan, MD
Asheville Cardiology Associates Research Department
Recruiting
Asheville, North Carolina, United States, 28803
Contacts
Principal Investigator:
William Pomeroy, MD
Novant Health Clinical Research/Heart & Vascular Institute
Recruiting
Charlotte, North Carolina, United States, 28204
Contacts
Principal Investigator:
Daniel Pu, MD
Mecklenburg Heart Specialists
Recruiting
Charlotte, North Carolina, United States, 28207
Contacts
Principal Investigator:
Aamer Qureshi, MD
Javara Inc.
Recruiting
Fayetteville, North Carolina, United States, 28304
Contacts
Principal Investigator:
Amol Bakekar, MD
Moses H Cone Memorial Hospital
Recruiting
Greensboro, North Carolina, United States, 27401
Contacts
Principal Investigator:
Muhammad Arida, MD
Wake Forest University Health Sciences
Recruiting
High Point, North Carolina, United States, 27262
Contacts
Principal Investigator:
H. Barrett Cheek, MD
Duke Cardiology
Recruiting
Morrisville, North Carolina, United States, 27560
Contacts
Principal Investigator:
Schuyler Jones, MD
Duke Vascular Surgery and Vein Center at Brier Creek
Recruiting
Raleigh, North Carolina, United States, 27617
Contacts
Principal Investigator:
E. Hope Weissler, MD
Novant Health Forsyth Medical Center
Recruiting
Winston-Salem, North Carolina, United States, 27103
Contacts
Principal Investigator:
Nizar Noureddine, MD
Aultman Hospital
Recruiting
Canton, Ohio, United States, 44710
Contacts
Principal Investigator:
Ramana Podugu, MD
Heart House Research Foundation LLC
Recruiting
Springfield, Ohio, United States, 45505
Contacts
Principal Investigator:
Mian Bilal Alam, MD
ProMedica Toledo Hospital
Recruiting
Toledo, Ohio, United States, 43606
Contacts
Principal Investigator:
Mujeeb Sheikh, MD
Genesis HealthCare System
Recruiting
Zanesville, Ohio, United States, 43701
Contacts
Principal Investigator:
Abdulhay Albirini, MD
South Oklahoma Heart Research, LLC
Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contacts
Principal Investigator:
Naeem Tahirkheli, MD
St. Luke's University Health Network
Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contacts
Principal Investigator:
Amit Gupta, MD
Capital Area Research LLC
Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contacts
Principal Investigator:
Venkatesh Nadar, MD
Wellspan Chambersburg Hospital
Recruiting
Chambersburg, Pennsylvania, United States, 17201
Contacts
Principal Investigator:
Aylmer Tang, MD
Penn Lancaster General Health Research Institute
Recruiting
Lancaster, Pennsylvania, United States, 17602
Contacts
Ann Marie Blair
annmarie.blair@pennmedicine.upenn.eduPrincipal Investigator:
Jian Shan, MD
Cardiology Associates of West Reading
Recruiting
West Reading, Pennsylvania, United States, 19611
Contacts
Principal Investigator:
Earl Hope, MD
WellSpan Heart and Vascular Research
Recruiting
York, Pennsylvania, United States, 17403
Contacts
Principal Investigator:
Rhian Davies, MD
AnMed Health Medical Center
Recruiting
Anderson, South Carolina, United States, 29621
Contacts
Principal Investigator:
John Meehan, MD
Monument Health Clinical Research
Recruiting
Rapid City, South Dakota, United States, 57701
Contacts
Principal Investigator:
Rajesh Pradhan, MD
Stern Cardiovascular Center
Recruiting
Germantown, Tennessee, United States, 38138
Contacts
Principal Investigator:
Tamunoinemi Bob-Manuel, MD
Ballad Health System
Recruiting
Greeneville, Tennessee, United States, 37745
Contacts
Principal Investigator:
Jack Whitaker, MD
Apex Research Foundation, LLC
Recruiting
Jackson, Tennessee, United States, 38301
Contacts
Principal Investigator:
Mohsin Alhaddad, MD
The Jackson Clinic, PA
Recruiting
Jackson, Tennessee, United States, 38305
Contacts
Principal Investigator:
Shahzad Shah, MD
TriStar Centennial Medical Center
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Principal Investigator:
David Huneycutt, MD
PharmaTex Research
Recruiting
Amarillo, Texas, United States, 79106
Contacts
Principal Investigator:
David Brabham, DO
Amarillo Heart Clinical Research Institute, Inc.
Recruiting
Amarillo, Texas, United States, 79124
Contacts
Principal Investigator:
Joaquin Martinez-Arraras, MD
Austin Heart
Recruiting
Austin, Texas, United States, 78705
Contacts
Principal Investigator:
Frank Zidar, MD
Vital Heart and Vein
Recruiting
Humble, Texas, United States, 77338
Contacts
Principal Investigator:
Rick Ganim, MD
Texas Cardiology Associates of Houston
Recruiting
Kingwood, Texas, United States, 77339
Contacts
Principal Investigator:
Ira Lieber, MD
Heart Institute of East Texas
Recruiting
Lufkin, Texas, United States, 75904
Contacts
Principal Investigator:
Ravinder Bachireddy, MD
DHR Health Institute for Research
Recruiting
McAllen, Texas, United States, 78504
Contacts
Principal Investigator:
Fiorella Llanos, MD
Austin Heart PLLC
Recruiting
Round Rock, Texas, United States, 78681
Contacts
Principal Investigator:
Joseph Szczytowski, MD
Austin Heart
Recruiting
San Marcos, Texas, United States, 78666
Contacts
Principal Investigator:
Faisal Syed, MD
Northwest Houston Heart Center
Recruiting
Tomball, Texas, United States, 77375
Contacts
Principal Investigator:
Shamaila Aslam, MD
Viva Heart and Vein
Recruiting
Tomball, Texas, United States, 77375
Contacts
Principal Investigator:
Taher Mandviwala, MD
TPMG Clinical Research
Recruiting
Newport News, Virginia, United States, 23606
Contacts
Principal Investigator:
Linda Schneider, MD
Chippenham Hospital
Recruiting
Richmond, Virginia, United States, 23225
Contacts
Principal Investigator:
Nayef Abouzaki, MD
Winchester Cardiology and Vascular Medicine
Recruiting
Winchester, Virginia, United States, 22601
Contacts
Principal Investigator:
Jeffrey Skiles, MD
MultiCare Institute for Research and Innovation
Recruiting
Puyallup, Washington, United States, 98372
Contacts
Principal Investigator:
Ahmad Slim, MD
MultiCare Institute for Research and Innovation
Recruiting
Tacoma, Washington, United States, 98405
Contacts
Principal Investigator:
Daniel Guerra, MD
Bellin Memorial Hospital
Recruiting
Green Bay, Wisconsin, United States, 54301
Contacts
Principal Investigator:
Jason Ricci, MD
Sponsor
Duke University
Last update posted
Aug 28, 2026
Last verified
Jul, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-28.