A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Aortic StenosisThe 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
50 to 80
Participation 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
Novartis Investigative SiteMontreal, Quebec
Canada
Contact Study Team
Novartis Investigative Site
Novartis Investigative SiteMontreal, Quebec
Canada
Contact Study Team
Novartis Investigative Site
Novartis Investigative SiteNorth York, Ontario
Canada
Contact Study Team
Novartis Investigative Site
Novartis Investigative SiteSainte Foy, Quebec
Canada
Contact Study Team
Novartis Investigative Site
Novartis Investigative SiteOttawa, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Novartis
- Participants Required
- More Information
- Study ID:
NCT05646381