Last Update: Apr 26, 2024
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTQJ230A12203
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Aortic Stenosis
Phase 2
Recruiting
502
Mar 07, 2024
Jan 03, 2029
All
50 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

Matching placebo

Matching placebo
Drug

Pelacarsen (TQJ230) 80mg

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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Novartis Pharmaceuticals

Novartis Pharmaceuticals