Study Description
The purpose of this study is to evaluate the efficacy, safety and tolerability of
pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in
slowing the progression of calcific aortic valve stenosis.
Interventions
Matching placebo
Pelacarsen (TQJ230) 80mg
Eligibility Criteria
Inclusion Criteria:
- Male and female ≥50 to <80 years of age
- Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- Mild or moderate calcific aortic valve stenosis
- At the randomization visit, participant must be optimally treated for existing CV
risk factors
Exclusion Criteria:
- Severe calcific aortic valve stenosis
- Uncontrolled hypertension
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count ≤ LLN
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply
Novartis Investigative Site
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Wien,A 1090,Austria
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Wien,1190,Austria
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North York,Ontario,M6b 3h7,Canada
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Montreal,Quebec,H3t 1e2,Canada
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Sainte Foy,Quebec,G1v 4g5,Canada
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Praha,12808,Czechia
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Jaromer Budova Polikliniky,551 01,Czechia
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Prague 4,146 24,Czechia
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Esbjerg,Dk-6700,Denmark
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Hvidovre,2650,Denmark
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Roskilde,4000,Denmark
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Viborg,Dk-8800,Denmark
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Paris,75015,France
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Paris 13,75651,France
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Dresden,Saxonia,01099,Germany
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Berlin,13353,Germany
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Frankfurt,60594,Germany
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Hamburg,22763,Germany
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Lueneburg,21339,Germany
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Muenchen,80636,Germany
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Ramat Gan,52621,Israel
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Beer Sheva,8457108,Israel
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Haifa,3339419,Israel
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Jerusalem,9112001,Israel
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Nahariya,22100,Israel
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Petach Tikva,4941492,Israel
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Milano,MI,20162,Italy
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Ancona,AN,60126,Italy
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Bologna,BO,40138,Italy
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Brescia,BS,25123,Italy
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Cona,FE,44100,Italy
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Milano,MI,20138,Italy
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Milano,MI,20157,Italy
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Vila Nova De Gaia,4434 502,Portugal
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Madrid,28041,Spain
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Salamanca,Castilla Y Leon,37007,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Madrid,28034,Spain
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Madrid,28040,Spain
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Basel,4031,Switzerland
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Geneve 14,1211,Switzerland
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Lugano,6903,Switzerland
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Zuerich,8091,Switzerland
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Leicester,Le3 9qp,United Kingdom
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London,Ec1a 7be,United Kingdom
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London,Se1 7eh,United Kingdom
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Middlesbrough,Ts4 3bw,United Kingdom
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Tyne And Wear,Ne29 8nh,United Kingdom
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Edinburgh,Ed16 4sa,United Kingdom
Massachusetts General Hospital Massachusetts General Hospital
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Boston,Massachusetts,02114,United States
Michael Honigberg
Ohio State University Heart and Vascular Res Org
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Columbus,Ohio,43210,United States
John Larry
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
David Funt
Overlook Medical Center
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Summit,New Jersey,07901,United States
Robert Fishberg
Cardiovascular Res Found
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Beverly Hills,California,90210,United States
Ronald P Karlsberg
Brigham and Womens Hosp Harvard Med School .
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Boston,Massachusetts,02115,United States
Rhanderson Cardoso
Virginia Heart
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Falls Church,Virginia,22042,United States
Tariq Haddad
Advanced Research for Health Improvement LLC
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Naples,Florida,34102,United States
Tracey Roth
New York Presbyterian Hospital Weill Cornell Med Ctr
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New York,New York,10021,United States
Samuel Kim
National Heart Institute
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Beverly Hills,California,90211,United States
Norman Lepor
Henry Ford Hospital
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Detroit,Michigan,48202,United States
Khaled Abdul-Nour
Carient Heart and Vascular
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Manassas,Virginia,20109,United States
Vikram Prasanna
Midwest Heart and Vascular Spec
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Overland Park,Kansas,66211,United States
Vasvi Singh
Wake Forest University Baptist Medical Center Wake Forest
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Winston-Salem,North Carolina,27157,United States
Judy Kennedy
Michael Shapiro
Valley Clinical Trials
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Northridge,California,91325,United States
Mehrdad Ariani
Minneapolis Heart Institute
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Minneapolis,Minnesota,55407,United States
Matthew Chu
Heart Center Research Llc .
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Huntsville,Alabama,35801,United States
Vernon R Hunter
Worldwide Contacts
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