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
Study Location
Novartis Investigative Site
Recruiting
Wien,1190,Austria
Novartis Investigative Site
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Wien,A 1090,Austria
Novartis Investigative Site
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North York,Ontario,M6b 3h7,Canada
Novartis Investigative Site
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Sainte Foy,Quebec,G1v 4g5,Canada
Novartis Investigative Site
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Montreal,Quebec,H3t 1e2,Canada
Novartis Investigative Site
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Prague 4,146 24,Czechia
Novartis Investigative Site
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Praha,12808,Czechia
Novartis Investigative Site
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Jaromer Budova Polikliniky,551 01,Czechia
Novartis Investigative Site
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Viborg,Dk-8800,Denmark
Novartis Investigative Site
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Hvidovre,2650,Denmark
Novartis Investigative Site
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Roskilde,4000,Denmark
Novartis Investigative Site
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Esbjerg,Dk-6700,Denmark
Novartis Investigative Site
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Paris 13,75651,France
Novartis Investigative Site
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Paris,75015,France
Novartis Investigative Site
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Hamburg,22763,Germany
Novartis Investigative Site
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Dresden,Saxonia,01099,Germany
Novartis Investigative Site
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Lueneburg,21339,Germany
Novartis Investigative Site
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Berlin,13353,Germany
Novartis Investigative Site
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Frankfurt,60594,Germany
Novartis Investigative Site
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Muenchen,80636,Germany
Novartis Investigative Site
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Petach Tikva,4941492,Israel
Novartis Investigative Site
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Nahariya,22100,Israel
Novartis Investigative Site
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Haifa,3339419,Israel
Novartis Investigative Site
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Ramat Gan,52621,Israel
Novartis Investigative Site
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Beer Sheva,8457108,Israel
Novartis Investigative Site
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Jerusalem,9112001,Israel
Novartis Investigative Site
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Brescia,BS,25123,Italy
Novartis Investigative Site
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Cona,FE,44100,Italy
Novartis Investigative Site
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Ancona,AN,60126,Italy
Novartis Investigative Site
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Milano,MI,20138,Italy
Novartis Investigative Site
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Milano,MI,20157,Italy
Novartis Investigative Site
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Milano,MI,20162,Italy
Novartis Investigative Site
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Bologna,BO,40138,Italy
Novartis Investigative Site
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Vila Nova De Gaia,4434 502,Portugal
Novartis Investigative Site
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Madrid,28041,Spain
Novartis Investigative Site
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Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
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Madrid,28034,Spain
Novartis Investigative Site
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Madrid,28040,Spain
Novartis Investigative Site
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Salamanca,Castilla Y Leon,37007,Spain
Novartis Investigative Site
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Geneve 14,1211,Switzerland
Novartis Investigative Site
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Zuerich,8091,Switzerland
Novartis Investigative Site
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Basel,4031,Switzerland
Novartis Investigative Site
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Lugano,6903,Switzerland
Novartis Investigative Site
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London,Ec1a 7be,United Kingdom
Novartis Investigative Site
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Tyne And Wear,Ne29 8nh,United Kingdom
Novartis Investigative Site
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Middlesbrough,Ts4 3bw,United Kingdom
Novartis Investigative Site
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London,Se1 7eh,United Kingdom
Novartis Investigative Site
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Edinburgh,Ed16 4sa,United Kingdom
Novartis Investigative Site
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Leicester,Le3 9qp,United Kingdom
Valley Clinical Trials
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Northridge,California,91325,United States
Mehrdad Ariani
Brigham and Womens Hosp Harvard Med School .
Recruiting
Boston,Massachusetts,02115,United States
Rhanderson Cardoso
Midwest Heart and Vascular Spec
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Overland Park,Kansas,66211,United States
Vasvi Singh
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
David Funt
New York Presbyterian Hospital Weill Cornell Med Ctr
Recruiting
New York,New York,10021,United States
Samuel Kim
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Ohio State University Heart and Vascular Res Org
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Columbus,Ohio,43210,United States
John Larry
Heart Center Research Llc .
Recruiting
Huntsville,Alabama,35801,United States
Vernon R Hunter
Cardiovascular Res Found
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Beverly Hills,California,90210,United States
Ronald P Karlsberg
Minneapolis Heart Institute
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Minneapolis,Minnesota,55407,United States
Matthew Chu
Wake Forest University Baptist Medical Center Wake Forest
Recruiting
Winston-Salem,North Carolina,27157,United States
Judy Kennedy
Michael Shapiro
Overlook Medical Center
Recruiting
Summit,New Jersey,07901,United States
Robert Fishberg
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Khaled Abdul-Nour
Carient Heart and Vascular
Recruiting
Manassas,Virginia,20109,United States
Vikram Prasanna
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Advanced Research for Health Improvement LLC
Recruiting
Naples,Florida,34102,United States
Tracey Roth
Massachusetts General Hospital Massachusetts General Hospital
Recruiting
Boston,Massachusetts,02114,United States
Michael Honigberg
Worldwide Contacts
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