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
North York,Ontario,M6b 3h7,Canada
Novartis Investigative Site
Recruiting
Sainte Foy,Quebec,G1v 4g5,Canada
Novartis Investigative Site
Recruiting
Montreal,Quebec,H3t 1e2,Canada
Novartis Investigative Site
Recruiting
Jaromer Budova Polikliniky,551 01,Czechia
Novartis Investigative Site
Recruiting
Nahariya,22100,Israel
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
Recruiting
Petach Tikva,49100,Israel
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Beer-Sheva,8457108,Israel
Novartis Investigative Site
Recruiting
Haifa,3339419,Israel
Novartis Investigative Site
Recruiting
Zuerich,8091,Switzerland
Novartis Investigative Site
Recruiting
Basel,4031,Switzerland
Novartis Investigative Site
Recruiting
Lugano,6903,Switzerland
Novartis Investigative Site
Recruiting
Geneve 14,1211,Switzerland
Novartis Investigative Site
Recruiting
London,Ec14 7be,United Kingdom
Novartis Investigative Site
Recruiting
Middlesbrough,Ts4 3bw,United Kingdom
Novartis Investigative Site
Recruiting
Tyne And Wear,Ne29 8nh,United Kingdom
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202,United States
Ohio State University Heart and Vascular Res Org
Recruiting
Columbus,Ohio,43210,United States
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Advanced Research for Health Improvement LLC
Recruiting
Naples,Florida,34102,United States
Virginia Heart
Recruiting
Falls Church,Virginia,22042,United States
New York Presbyterian Hospital Weill Cornell Med Ctr
Recruiting
New York,New York,10021,United States
Cardiovascular Res Found
Recruiting
Beverly Hills,California,90210,United States
Carient Heart and Vascular
Recruiting
Manassas,Virginia,20109,United States
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
Heart Center Research Llc .
Recruiting
Huntsville,Alabama,35801,United States
Worldwide Contacts
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