Study Description
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. 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.
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Placebo in 1.5ml
Eligibility Criteria
Inclusion Criteria:
- At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as
any one of the following:
1. 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
2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
3. High 10-year ASCVD risk ≥20%, or
4. 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.
Exclusion Criteria:
- 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 Location
Cardiovascular Res Found
Recruiting
Beverly Hills,California,90210,United States
Ronald P Karlsberg
VA Palo Alto Health Care System
Recruiting
Palo Alto,California,94304-1207,United States
Shriram Nallamshetty
Longwood Research
Recruiting
Huntsville,Alabama,35801,United States
Saadat Ansari
Cognitive Clinical Trials LLC
Recruiting
Phoenix,Arizona,85044,United States
Kenneth Steil
California Medical Research Associates Inc
Recruiting
Northridge,California,91324,United States
Ramachandra Patak
Kaiser Permanente San Diego Cardiology
Recruiting
San Diego,California,92108,United States
Bahram Khadivi
Clinical Research Advantage Fiel Family and Sports Med, PC
Recruiting
Tempe,Arizona,85283,United States
Thomas Fiel
Valley Clinical Trials .
Recruiting
Northridge,California,91325,United States
Fahed Bitar
Mehrdad Ariani
San Diego Cardiac Center
Recruiting
San Diego,California,92123,United States
Jiken Bhatt
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
Seth J Baum
Synexus Clinical Research US Inc
Recruiting
Tucson,Arizona,85741,United States
Judith Brown
Central Alabama Research
Recruiting
Birmingham,Alabama,35209,United States
Barry McLean
South Denver Cardiology Associates PC
Recruiting
Littleton,Colorado,80120,United States
Paul Jurgens
Cardiology Ass of Fairfield County .
Recruiting
Stamford,Connecticut,06905,United States
Charles Rouse
Uconn John Dempsey Hospital
Recruiting
Farmington,Connecticut,06030,United States
John Glenn Tiu
Synexus Synexus
Recruiting
Glendale,Arizona,85306,United States
Elysa Shaw
Rachel Fadden
Mobile Heart Specialists
Recruiting
Mobile,Alabama,36608,United States
Christopher S Brown
Stanford University Medical Center Center For Clinical Research
Recruiting
Stanford,California,94305,United States
Joshua Knowles
Cordova Clinical Research
Recruiting
Sacramento,California,95841,United States
Muhammad Yusufzai
Keck Medical Center USC Keck School of Medicine of USC
Recruiting
Los Angeles,California,90033,United States
Parveen Garg
Uni of California at Los Angeles
Recruiting
Torrance,California,90502,United States
Matthew Jay Budoff
Clinical Research Inst of Arizona
Recruiting
Sun City West,Arizona,85375,United States
Jalal Abbas
Hope Clinical Research
Recruiting
Canoga Park,California,91303,United States
Hessam Aazami
Blue Coast Research Center LLC .
Recruiting
Vista,California,92081,United States
Hanh Bui
Mohamed Khalil
Charles R Drew Uni Of Med And Sci
Recruiting
Los Angeles,California,90059,United States
Arnel Joaquin
Eastern Shore Research Group, LLC
Recruiting
Fairhope,Alabama,36532,United States
Michael S Pursley
Acclaim Clinical Research
Recruiting
San Diego,California,92120,United States
John Beckes
Cardiology Associates Medical Group
Recruiting
Ventura,California,93003,United States
Angelica Medina
Omid Fatemi
The Center for Clinical Trials
Recruiting
Saraland,Alabama,36571,United States
Howard Rubenstein
Janice Orr
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Synexus Clinical Research Advantage
Recruiting
Birmingham,Alabama,35211,United States
William Kirby
University of California San Diego .
Recruiting
San Diego,California,92103,United States
Michael John Wilkinson
Lenzmeier Family Practice
Recruiting
Glendale,Arizona,85308,United States
Thomas Lenzmeier
Clinical Trials Research Sacramento
Recruiting
Sacramento,California,95821-2134,United States
Jeffrey D Wayne
C for Endo Diabetes and MD
Recruiting
Newhall,California,91321,United States
Sina Tebi
Interv Cardiology Med Grp
Recruiting
West Hills,California,91307,United States
Farhad Rafii
Chase Medical Research LLC Research
Recruiting
Waterbury,Connecticut,06708,United States
Joseph Soufer
Maria Petruzzelli
Alaska Heart and Vascular
Recruiting
Anchorage,Alaska,99508,United States
Jacob Kelly
Encompass Clinical Research
Recruiting
Spring Valley,California,91978,United States
Hanid Audish
Worldwide Contacts
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