A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
- Conditions
- Primary Prevention of Atherosclerotic Cardiovascular Disease
- Interventions
- Drug: Placebo in 1.5ml
- Registration Number
- NCT05739383
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.
Randomized participants will receive study medication (inclisiran or placebo), administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 14013
-
At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
- Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any other major epicardial coronary artery, or
- Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
- High 10-year ASCVD risk ≥20%, or
- Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
-
LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
- History of major ASCVD event.
- History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
- Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
- Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
- Active liver disease or hepatic dysfunction
- Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
- Pregnant or nursing (lactating) women
- Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo in 1.5ml Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran. Inclisiran sodium 300mg Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
- Primary Outcome Measures
Name Time Method Time to the first occurrence of 4P-MACE Time to the first occurrence of 4P-MACE (up to approximately 75 months) 4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
- Secondary Outcome Measures
Name Time Method Time to the first occurrence of 3P-MACE Time to the first occurrence of 3P-MACE (up to approximately 75 months) 3-Point-Major Adverse Cardiovascular Events (3P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)
Total number of first or repeated CV events (4P MACE) up to 75 months Total 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization)
Total number of first or repeated CV events (3P MACE) up to 75 months Total 3P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)
Time to occurrence of Cardiovascular death Time to Cardiovascular death (up to 75 months) CV death is defined as death due to cardiovascular events.
Time to occurrence of death due to any reason Time to all-cause mortality (up to 75 months) All-cause mortality is death due to any reason.
Trial Locations
- Locations (247)
Novartis Investigative Site
🇻🇳Ho Chi Minh, Vietnam
Research and Cardiovascular Corp
🇵🇷Ponce, Puerto Rico
Central Alabama Research
🇺🇸Birmingham, 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
Ascension St Vincents
🇺🇸Birmingham, Alabama, United States
Eastern Shore Research Institute
🇺🇸Fairhope, Alabama, United States
Mobile Heart Specialists
🇺🇸Mobile, Alabama, United States
The Center for Clinical Trials
🇺🇸Saraland, Alabama, United States
Alaska Heart and Vascular
🇺🇸Anchorage, Alaska, United States
Synexus
🇺🇸Glendale, Arizona, United States
Lenzmeier Family Practice
🇺🇸Glendale, Arizona, United States
Qway Research
🇺🇸Hialeah, Florida, United States
Indago Research and Health Ctr Inc
🇺🇸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
A&A Research Group Inc
🇺🇸Miami, Florida, United States
Eminat 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
East Coast Research
🇺🇸Canton, Georgia, United States
Javara Research
🇺🇸Stephenville, Texas, 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
Northwest Heart Clinical Rsrch LLC
🇺🇸Arlington Heights, Illinois, United States
Chicago Clinical Research Inst
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Flourish Research
🇺🇸Grandwood Park, Illinois, United States
Cardiovascular Services
🇺🇸Peoria, Illinois, United States
Beacon Health System
🇺🇸Elkhart, Indiana, United States
Franciscan Health Services Research Center
🇺🇸Indianapolis, 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 Heart Hospital
🇺🇸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
Christus Health Central Lousia
🇺🇸Alexandria, Louisiana, United States
Cardiovascular Associates Research
🇺🇸Covington, Louisiana, United States
Louisiana Heart Center Research
🇺🇸Slidell, Louisiana, United States
Avant Research Associates LLC
🇺🇸Crowley, Louisiana, United States
North Shore Heart and Vascular
🇺🇸Mandeville, Louisiana, United States
Bethesda Medical Clinic
🇺🇸Marrero, Louisiana, United States
NOLA Care Clinical Research
🇺🇸Metairie, Louisiana, United States
Omega Clinical Research
🇺🇸Metairie, Louisiana, United States
Barnum Medical Research Inc
🇺🇸Natchitoches, Louisiana, United States
Northeast Cardiology Associates
🇺🇸Bangor, Maine, United States
St Louis V A Medical Center
🇺🇸Saint Louis, Missouri, United States
St Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Lincoln Internal Medicine Associates
🇺🇸Lincoln, Nebraska, United States
IMA Research
🇺🇸Mount Airy, North Carolina, United States
Multispecialty Research Ass Of NC
🇺🇸Raleigh, North Carolina, United States
Accellacare
🇺🇸Knoxville, Tennessee, United States
Providence Medical Group
🇺🇸Dayton, Ohio, United States
NexGen Research
🇺🇸Lima, Ohio, United States
Rama Research LLC
🇺🇸Marion, Ohio, United States
Heart House Research Foundation
🇺🇸Springfield, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Hightower Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research LLC
🇺🇸Oklahoma City, Oklahoma, United States
CCT Hatboro Medical Associates
🇺🇸Hatboro, Pennsylvania, United States
Capital Area Research LLC
🇺🇸Newport, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Frontier Clinical Research LLC
🇺🇸Smithfield, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
New Phase Research And Development
🇺🇸Knoxville, Tennessee, United States
Clinical Research Solution
🇺🇸Cypress, Texas, United States
VA North Texas Health Care System
🇺🇸Dallas, Texas, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
SW Family Medicine Associates
🇺🇸Dallas, Texas, United States
Doctors Hospital at Renaissance
🇺🇸Edinburg, Texas, United States
David Turbay MD PLLC
🇺🇸El Paso, Texas, United States
Texas Health Physicians Group
🇺🇸Fort Worth, Texas, United States
East Texas Cardiology PA
🇺🇸Houston, Texas, United States
Primecare Medical Group
🇺🇸Houston, Texas, United States
Northwest Houston Cardiology PA
🇺🇸Houston, Texas, United States
MedCare Pharma LLC
🇺🇸Houston, Texas, United States
Heart Care Associates P C
🇺🇸Hopewell, Virginia, United States
Cognitive Clinical Trials LLC
🇺🇸Phoenix, 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
🇺🇸Murray, Utah, United States
Cardiovascular Res Found
🇺🇸Beverly Hills, California, United States
National Heart Institute
🇺🇸Beverly Hills, California, United States
Hope Clinical Research
🇺🇸Canoga Park, 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
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
Stanford University Medical Center
🇺🇸Stanford, California, United States
Uni of California at Los Angeles
🇺🇸Torrance, California, United States
Tilda Research
🇺🇸Tustin, 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
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
East Coast Institute for Research
🇺🇸Jacksonville, 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
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
Regenerate Clinical Trial
🇺🇸Miami, Florida, United States
L and C Professional Medical Institute
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Peace River Cardiovascular Center
🇺🇸Port Charlotte, Florida, United States
East Coast Inst for Research LLC
🇺🇸Saint Augustine, Florida, United States
Advanced Medical Research Center
🇺🇸Saint Petersburg, Florida, United States
Cardiovascular Center Of Sarasota
🇺🇸Sarasota, 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
CV Ins of the South
🇺🇸Opelousas, Louisiana, United States
Cardiovascular Solutions LLC
🇺🇸Shreveport, Louisiana, United States
Monroe Research Llc
🇺🇸West Monroe, Louisiana, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
Ascension Saint Agnes Heart Care
🇺🇸Baltimore, Maryland, United States
Metropolitan Cardiovascular Consultants Llc
🇺🇸Beltsville, Maryland, United States
Johns Hopkins University
🇺🇸Columbia, Maryland, United States
Anderson Medical Research
🇺🇸Fort Washington, Maryland, United States
Capitol Cardiology Associates
🇺🇸Lanham, Maryland, United States
MGH
🇺🇸Boston, Massachusetts, United States
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
AA Medical Research Center
🇺🇸Flint, Michigan, United States
MyMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
Central University Of Michigan
🇺🇸Saginaw, Michigan, United States
Troy Internal Medicine Research
🇺🇸Troy, Michigan, United States
Trinity Health Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Essentia Health Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Park Nicollet Institute
🇺🇸Saint Louis Park, Minnesota, United States
Fairview Health Services
🇺🇸Saint Paul, Minnesota, United States
Elite Clinical Research LLC
🇺🇸Jackson, Mississippi, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
VAMC Research-G V Sonny Montgomery Clinic
🇺🇸Jackson, Mississippi, United States
David M Headley Clinic
🇺🇸Port Gibson, Mississippi, United States
Cardiology Associates of North MS
🇺🇸Tupelo, Mississippi, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Barnes Jewish Hosp-Washington Univ
🇺🇸Saint Louis, Missouri, United States
VA Medical Center - NWI, Endocrine Studies (R151)
🇺🇸Omaha, Nebraska, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Advanced Heart Care, LLC
🇺🇸Bridgewater, New Jersey, United States
Cardiovas Assoc of Delaware Valley
🇺🇸Elmer, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
New Jersey Heart
🇺🇸Linden, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
New York Presbyterian Queens
🇺🇸Flushing, New York, United States
IMA Medical Research PC
🇺🇸Kew Gardens, New York, United States
Mid Hudson Medical Research PLLC
🇺🇸New Windsor, New York, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Endocrine Associates of Long Island P C
🇺🇸Smithtown, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
Cary Research Group
🇺🇸Cary, North Carolina, United States
Moses Cone Hospital
🇺🇸Greensboro, North Carolina, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Physicians East Endocrinology
🇺🇸Greenville, North Carolina, United States
Adv Imaging Prev and Clin Research
🇺🇸Wilmington, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Altru Health Research Dept.
🇺🇸Grand Forks, North Dakota, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Synexus Clinical Research
🇺🇸Columbus, Ohio, United States
Primed Clinical Research
🇺🇸Dayton, Ohio, United States
Care Access
🇺🇸Warwick, Rhode Island, United States
Columbia VA Health Care System
🇺🇸Columbia, South Carolina, United States
Bon Secours Medical Group
🇺🇸Greenville, South Carolina, United States
Mountain View Clincal Research Inc
🇺🇸Greer, South Carolina, United States
Trident Cardiology
🇺🇸Ladson, South Carolina, United States
Main Street Physicians Care
🇺🇸Little River, South Carolina, United States
Care Access Rapid City
🇺🇸Rapid City, South Dakota, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Wellmont CVA Heart Institute
🇺🇸Greenville, Tennessee, United States
Apex Cardiology Research Associates of Jackson
🇺🇸Jackson, Tennessee, United States
Cardiovascular Res of Knoxville LLC
🇺🇸Powell, Tennessee, United States
Tennessee Center For Clinical Trials
🇺🇸Tullahoma, Tennessee, United States
Pharma Tex Research
🇺🇸Amarillo, Texas, United States
Amarillo Heart Clin Rsh Inst
🇺🇸Amarillo, Texas, United States
North Hills Medical Research Inc
🇺🇸Bedford, Texas, United States
Biopharma Informatic LLC
🇺🇸Houston, Texas, United States
Texas Cardiology Assocs Of Houston
🇺🇸Kingwood, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
East Texas Research Associates Inc.
🇺🇸Livingston, Texas, United States
Discovery Clinical Trials
🇺🇸Pflugerville, Texas, United States
Epic Medical Research
🇺🇸Red Oak, Texas, United States
Northeast Clinical Research of San Antonio LLC
🇺🇸San Antonio, Texas, United States
Consano Clinical Research LLC
🇺🇸Shavano Park, Texas, United States
NRG Wellness Center
🇺🇸Sugar Land, Texas, United States
Northwest Houston Clinical Research PLLC
🇺🇸Tomball, Texas, United States
Comprehensive Center
🇺🇸Weslaco, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Diabetes And Endocrine Specialists
🇺🇸Sandy, Utah, United States
Burke Internal Medicine and Research
🇺🇸Burke, Virginia, United States
Virginia Heart
🇺🇸Falls Church, Virginia, United States
Carient Heart and Vascular
🇺🇸Manassas, Virginia, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Roanoke Heart Institute
🇺🇸Roanoke, Virginia, United States
Centricity Research Suffolk Fam Med
🇺🇸Suffolk, Virginia, United States
MultiCare Ins Research Innovation
🇺🇸Puyallup, Washington, United States
Universal Research Group LLC
🇺🇸Tacoma, Washington, United States
Confluence Health Hospital
🇺🇸Wenatchee, Washington, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Midwest Endocrinology Associates
🇺🇸Milwaukee, Wisconsin, United States
Cardiovascular Research and Education Foundation, Inc
🇺🇸Wausau, Wisconsin, United States