A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Last Update: Jun 19, 2025
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:
NCT05646381
Novartis Reference Number:CTQJ230A12203
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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
Phase2
Recruiting
502
Mar 07, 2024
Mar 12, 2030
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

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Wien,1190,Austria

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Innsbruck,Tyrol,6020,Austria

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Wien,A 1090,Austria

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Hradec Kralove,500 02,Czechia

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Jaromer budova Polikliniky,551 01,Czechia

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Petach Tikva,4941492,Israel

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Pozzilli,IS,86077,Italy

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Ancona,AN,60126,Italy

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Amsterdam,1105 az,Netherlands

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Falls Church,Virginia,22042,United States

Cynthia E Alvarez
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Tariq Haddad

Ohio State University

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Columbus,Ohio,43210,United States

Annie Kellum
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Wesley Milks

William Beaumont Hospital

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Royal Oak,Michigan,48073-4192,United States

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Judy Kennedy
Michael Shapiro

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Chelsea Waller
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Vasvi Singh

University Of Minnesota

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Melanie Crawley
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Strong Memorial Hospital

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AA Medical Research Center

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Flint,Michigan,48504,United States

Muhammad Ahteesham
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Ahmed Arif

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Monalisa Nzenwa
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Ronald P Karlsberg

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Sydney Monserrate
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Perelman School of Medicine

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National Heart Institute

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Source URL: https://prod1.novartis.com/clinicaltrials/study/nct05646381

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  2. #trial-eligibility
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