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
Sainte Foy,Quebec,G1V 4G5,Canada
Novartis Investigative Site
Recruiting
Haifa,3339419,Israel
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
Recruiting
Nahariya,22100,Israel
Novartis Investigative Site
Recruiting
Beer-Sheva,8457108,Israel
Novartis Investigative Site
Recruiting
Tyne And Wear,NE29 8NH,United Kingdom
Advanced Research for Health Improvement LLC
Recruiting
Naples,Daniel Marin (239-300-0586) email: [email protected] -- Tracey Roth,34102 - Florida,United States
Carient Heart and Vascular
Recruiting
Manassas,Nazish Khan (+1 70 333 58 750) email: [email protected] -- Vikram Prasanna,20109 - Virginia,United States
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Yoelis Deleon (561-756-8206) email: [email protected] -- David Funt,33434 - Florida,United States
Worldwide Contacts
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