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
Recruiting
Montreal,Quebec,H3t 1e2,Canada
Novartis Investigative Site
Recruiting
Sainte Foy,Quebec,G1v 4g5,Canada
Novartis Investigative Site
Recruiting
North York,Ontario,M6b 3h7,Canada
Novartis Investigative Site
Recruiting
Jaromer Budova Polikliniky,551 01,Czechia
Novartis Investigative Site
Recruiting
Prague 2,128 08,Czechia
Novartis Investigative Site
Recruiting
Praha 4,Czech Republic,140 21,Czechia
Novartis Investigative Site
Recruiting
Esbjerg,Dk-6700,Denmark
Novartis Investigative Site
Recruiting
Viborg,Dk-8800,Denmark
Novartis Investigative Site
Recruiting
Muenchen,80636,Germany
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Haifa,3339419,Israel
Novartis Investigative Site
Recruiting
Nahariya,22100,Israel
Novartis Investigative Site
Recruiting
Beer Sheva,8457108,Israel
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
Recruiting
Petach Tikva,49100,Israel
Novartis Investigative Site
Recruiting
Torrette Ancona,AN,60126,Italy
Novartis Investigative Site
Recruiting
Brescia,BS,25123,Italy
Novartis Investigative Site
Recruiting
Milano,MI,20138,Italy
Novartis Investigative Site
Recruiting
Milano,MI,20157,Italy
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
Recruiting
Basel,4031,Switzerland
Novartis Investigative Site
Recruiting
Zuerich,8091,Switzerland
Novartis Investigative Site
Recruiting
Lugano,6903,Switzerland
Novartis Investigative Site
Recruiting
Geneve 14,1211,Switzerland
Novartis Investigative Site
Recruiting
Middlesbrough,Ts4 3bw,United Kingdom
Novartis Investigative Site
Recruiting
Tyne And Wear,Ne29 8nh,United Kingdom
Novartis Investigative Site
Recruiting
London,Ec14 7be,United Kingdom
Novartis Investigative Site
Recruiting
Edinburgh,Ed16 4sa,United Kingdom
Novartis Investigative Site
Recruiting
London,Se1 7eh,United Kingdom
Carient Heart and Vascular
Recruiting
Manassas,Virginia,20109,United States
Vikram Prasanna
New York Presbyterian Hospital Weill Cornell Med Ctr
Recruiting
New York,New York,10021,United States
Samuel Kim
Advanced Research for Health Improvement LLC
Recruiting
Naples,Florida,34102,United States
Tracey Roth
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
Tariq Haddad
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Khaled Abdul-Nour
Midwest Heart and Vascular Spec
Recruiting
Overland Park,Kansas,66211,United States
Vasvi Singh
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
David Funt
Ohio State University Heart and Vascular Res Org
Recruiting
Columbus,Ohio,43210,United States
John Larry
Brigham and Womens Hosp Harvard Med School .
Recruiting
Boston,Massachusetts,02115,United States
Rhanderson Cardoso
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Heart Center Research Llc .
Recruiting
Huntsville,Alabama,35801,United States
Vernon R Hunter
Overlook Medical Center
Recruiting
Summit,New Jersey,07901,United States
Robert Fishberg
Cardiovascular Res Found
Recruiting
Beverly Hills,California,90210,United States
Ronald P Karlsberg
Worldwide Contacts
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