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

Last Update: Mar 25, 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.

Condition

Aortic Stenosis

Phase

Phase2

Overall Status

Recruiting

Number of Participants

502

Start Date

Mar 07, 2024

Completion Date

Jan 03, 2029

Gender

All

Age(s)

50 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

Matching placebo

Drug

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

Novartis Investigative Site

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Wien,1190,Austria

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Wien,A 1090,Austria

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Innsbruck,Tyrol,6020,Austria

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Linz,4021,Austria

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Genk,3600,Belgium

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Yvoir,5530,Belgium

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Kortrijk,8500,Belgium

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Ottawa,Ontario,K1y 4w7,Canada

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Montreal,Quebec,H1t 1c8,Canada

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North York,Ontario,M6b 3h7,Canada

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Montreal,Quebec,H3t 1e2,Canada

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Sainte Foy,Quebec,G1v 4g5,Canada

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Jaromer Budova Polikliniky,551 01,Czechia

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Prague 4,146 24,Czechia

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Praha,12808,Czechia

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Hradec Kralove,500 02,Czechia

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Esbjerg,Dk-6700,Denmark

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Hvidovre,2650,Denmark

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Roskilde,4000,Denmark

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Viborg,Dk-8800,Denmark

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Pessac Cedex,33604,France

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Paris 13,75651,France

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Paris,75015,France

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Paris,75012,France

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Poitiers,86021,France

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Rennes,35033,France

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Essen,45147,Germany

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Lueneburg,21339,Germany

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Muenchen,80636,Germany

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Dresden,Saxonia,01099,Germany

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Berlin,13353,Germany

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Frankfurt,60594,Germany

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Hamburg,22763,Germany

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Petach Tikva,4941492,Israel

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Ramat Gan,52621,Israel

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Beer Sheva,8457108,Israel

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Haifa,3339419,Israel

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Jerusalem,9112001,Israel

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Nahariya,22100,Israel

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Milano,MI,20157,Italy

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Pozzilli,IS,86077,Italy

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Milano,MI,20162,Italy

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Ancona,AN,60126,Italy

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Padova,PD,35128,Italy

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Bologna,BO,40138,Italy

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Brescia,BS,25123,Italy

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Cona,FE,44100,Italy

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Milano,MI,20138,Italy

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Amsterdam,1090 hm,Netherlands

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Amsterdam,1105 az,Netherlands

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Rotterdam,3079 dz,Netherlands

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Coimbra,3000 075,Portugal

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Vila Nova De Gaia,4434 502,Portugal

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Madrid,28034,Spain

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Caceres,Extremadura,10003,Spain

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Madrid,28040,Spain

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Madrid,28041,Spain

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Salamanca,Castilla Y Leon,37007,Spain

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Valencia,Comunidad Valenciana,46010,Spain

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Basel,4031,Switzerland

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Geneve 14,1211,Switzerland

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Lugano,6903,Switzerland

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Zuerich,8091,Switzerland

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Edinburgh,Ed16 4sa,United Kingdom

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Londonderry,Bt47 1sb,United Kingdom

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Leicester,Le3 9qp,United Kingdom

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London,Ec1a 7be,United Kingdom

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London,Se1 7eh,United Kingdom

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Middlesbrough,Ts4 3bw,United Kingdom

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Tyne And Wear,Ne29 8nh,United Kingdom

Massachusetts General Hospital

Recruiting

Boston,Massachusetts,02114,United States

Michael Honigberg

Minneapolis Heart Institute

Recruiting

Minneapolis,Minnesota,55407,United States

Haley Hanson

Phone: 612-863-3900

Email: haley.hanson@allina.com

Matthew Chu

Ohio State University

Recruiting

Columbus,Ohio,43210,United States

Annie Kellum

Phone: 614-685-4619

Email: annie.kellum@osumc.edu

John Larry

Heart Center Research Llc

Recruiting

Huntsville,Alabama,35801,United States

Carolyn Keefer

Phone: 256-519-8255

Email: ckeefer@theheartcenter.md

Vernon R Hunter

Advanced Research for Health Improvement LLC

Recruiting

Naples,Florida,34102,United States

Julian Ortiz

Phone: 239-300-0586

Email: julian.ortiz@arhiusa.com

Tracey Roth

Icahn School of Med at Mt Sinai

Recruiting

New York,New York,10029,United States

Rosa De Jesus Machargo

Phone: 212-659-9174

Email: rosa.dejesus-machargo@mssm.edu

Waqas Malick

Carient Heart and Vascular

Recruiting

Manassas,Virginia,20109,United States

Vikram Prasanna

Sydney Monserrate

Phone: +1 70 333 58 750

Email: smonserrate@carient.com

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Phone: 301-289-5221

Norman Lepor

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston,Massachusetts,02115,United States

Camila Souza Freire

Phone: 617-525-1227

Email: csouzafreire@bwh.harvard.edu

Rhanderson Cardoso

Strong Memorial Hospital

Recruiting

Rochester,New York,14642,United States

Elizabeth Anderson

Phone: 716-275-7753

Email: Elizabeth_Anderson@URMC.Rochester.edu

Robert Block

Overlook Medical Center

Recruiting

Summit,New Jersey,07901,United States

Kristal Mendoza

Phone: 908-522-6279

Email: Kristal.mendoza@atlantichealth.org

Robert Fishberg

Perelman School of Medicine

Recruiting

Philadelphia,Pennsylvania,19104,United States

Archna Bajaj

Karen Terembula

Email: kterembu@pennmedicine.upenn.edu

UC San Francisco Medical Center

Recruiting

San Francisco,California,94143,United States

Malika Saxena

Phone: 415-476-8338

Email: mallika.saxena@ucsf.edu

Sammy Elmariah

Midwest Heart and Vascular Spec

Recruiting

Overland Park,Kansas,66211,United States

Chelsea Waller

Phone: 913-253-3000

Email: Chelsea.Waller@HCAHealthcare.com

Vasvi Singh

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem,North Carolina,27157,United States

Michael Shapiro

Sophia Dawson

Email: sadawson@wakehealth.edu

Valley Clinical Trials

Recruiting

Northridge,California,91325,United States

Chase Miller

Phone: 818-280-4220

Email: chase@valleyclinicaltrials.com

Mehrdad Ariani

University Of Minnesota

Recruiting

Minneapolis,Minnesota,55455,United States

Daniel Duprez

Melanie Crawley

Phone: 612-624-4948

Email: Crawl027@umn.edu

Virginia Heart

Recruiting

Falls Church,Virginia,22042,United States

Christina Good

Phone: 703-766-5920

Email: cgood@virginiaheart.com

Tariq Haddad

Tufts Medical Center

Recruiting

Boston,Massachusetts,02111,United States

Benjamin Wessler

Jamie Rubinstein

Phone: 617-636-5897

Email: Jamie.Rubinstein@TuftsMedicine.org

Henry Ford Hospital

Recruiting

Detroit,Michigan,48202,United States

Jodi Carter, BS, CCRP

Phone: 313-916-3613

Khaled Abdul-Nour

Carl and Edyth Lindner Ctr for Resch and Ed at The Christ Hosp

Recruiting

Cincinnati,Ohio,45219,United States

Phone: 513-585-1777

Sitaramesh Emani

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

David Funt

Yoelis Deleon

Phone: 561-756-8206

Email: ydeleon@flourishresearch.com

New York Presbyterian Hospital

Recruiting

New York,New York,10021,United States

Rose Spuhler

Phone: 212-746-2932

Email: ros4026@med.cornell.edu

Samuel Kim

Cardiovascular Res Found

Recruiting

Beverly Hills,California,90210,United States

Monalisa Nzenwa

Phone: 310-278-3400

Email: MonaLisa.Nzenwa@cvmg.com

Ronald P Karlsberg

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