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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Sponsor: Novartis Pharmaceuticals
Summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
Key Details
Gender
All
Age Range
40 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
14012
Start Date
2023-03-09
Completion Date
2029-04-16
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Subcutaneous injection in pre-filled syringe.
Placebo in 1.5ml
Matching placebo in 1.5ml solution for injection
Locations (983)
Central Alabama Research
Birmingham, Alabama, United States
UAB St Vincents
Birmingham, Alabama, United States
Eastern Shore Research Institute
Fairhope, Alabama, United States
G and L Research LLC
Foley, Alabama, United States
Longwood Research
Huntsville, Alabama, United States
CB Flock Corporation
Mobile, Alabama, United States
The Center for Clinical Trials
Saraland, Alabama, United States
Synexus
Glendale, Arizona, United States
Lenzmeier Family Practice
Glendale, Arizona, United States
Clinical Research Inst of Arizona
Sun City West, Arizona, United States
Clinical Research Advantage Fiel Family and Sports Med, PC
Tempe, Arizona, United States
Synexus Clinical Research US Inc
Tucson, Arizona, United States
Cardiovascular Res Found
Beverly Hills, California, United States
National Heart Institute
Beverly Hills, California, United States
Alliance Clinical
Canoga Park, California, United States
Inland Psychiatric Medical Group
Chino, California, United States
Valley Clinical Trials Inc
Covina, California, United States
Keck Medical Center USC
Los Angeles, California, United States
Charles R Drew University of Medicine and Science
Los Angeles, California, United States
C for Endo Diabetes and MD
Newhall, California, United States
California Medical Research Associates Inc
Northridge, California, United States
Valley Clinical Trials
Northridge, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Clinical Trials Research Sacramento
Sacramento, California, United States
Cordova Clinical Research
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Kaiser Permanente San Diego
San Diego, California, United States
Acclaim Clinical Research
San Diego, California, United States
San Diego Cardiac Center
San Diego, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Harbor UCLA Medical Center
Torrance, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Blue Coast Research Center LLC
Vista, California, United States
Interv Cardiology Med Grp
West Hills, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Cardiology Ass of Fairfield County
Stamford, Connecticut, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Nova Clinical Research LLC
Bradenton, Florida, United States
Bay Care Medical Group
Clearwater, Florida, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Cardiology Research Associates
Daytona Beach, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
Personal Physicians Care
Delray Beach, Florida, United States
Fleming Island Ctr Clinical Res.
Fleming Island, Florida, United States
Proactive Clinical Research
Fort Lauderdale, Florida, United States
Qway Research
Hialeah, Florida, United States
Sister Life Research Inc
Hialeah, Florida, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
South Florida Rsrch Solutions LLC
Hollywood, Florida, United States
Zenith Clinical Research
Hollywood, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
UF Health Science Center
Jacksonville, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Infinite Clinical Research
Miami, Florida, United States
Springs Medical And Research
Miami, Florida, United States
L and C Professional Medical Institute
Miami, Florida, United States
Regenerate Clinical Trial
Miami, Florida, United States
International Research Associates LLC
Miami, Florida, United States
A&A Research Group Inc
Miami, Florida, United States
Meridian International Research
Miami Gardens, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
RM Medical Research Inc
Miami Lakes, Florida, United States
Indago Research and Health Ctr Inc
Miami Lakes, Florida, United States
FXM Clin Res Miramar LLC
Miramar, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
CTMD Research
Palm Springs, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
Fam Medical Specialists Of Fl Plc
Plant City, Florida, United States
St Johns Center
Ponte Vedra, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
East Coast Inst for Research LLC
Saint Augustine, Florida, United States
Cardiovascular Center Of Sarasota
Sarasota, Florida, United States
Advanced Medical Research Center
St. Petersburg, Florida, United States
James A Haley Veterans Hospital
Tampa, Florida, United States
BayCare Health System
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Flourish Research
Winter Park, Florida, United States
East Coast Research
Canton, Georgia, United States
Javara Research
Fayetteville, Georgia, United States
The Jones Center For Diabetes And Endocrine Wellness
Macon, Georgia, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, United States
East West Research Institute
Honolulu, Hawaii, United States
Kootenai Heart Clinic-Sandpoint
Sandpoint, Idaho, United States
Endeavor Health Clinical Op- NCH
Arlington Heights, Illinois, United States
Chicago Clinical Research Inst
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Cardiovascular Services
Peoria, Illinois, United States
Beacon Health System
Elkhart, Indiana, United States
Buynak Clinical Research PC
Valparaiso, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Cotton O Neil Clinical Res Center
Topeka, Kansas, United States
Kansas Nephrology Research Institute LLC
Wichita, Kansas, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
The Research Group
Lexington, Kentucky, United States
Research Integrity LLC
Owensboro, Kentucky, United States