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

Last Update: Apr 16, 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

Mar 12, 2030

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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Innsbruck,Tyrol,6020,Austria

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Linz,4021,Austria

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Wien,1190,Austria

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Wien,A 1090,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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Montreal,Quebec,H1t 1c8,Canada

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Montreal,Quebec,H3t 1e2,Canada

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Sainte Foy,Quebec,G1v 4g5,Canada

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Montreal,Quebec,H4a 3j1,Canada

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Ottawa,Ontario,K1y 4w7,Canada

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North York,Ontario,M6b 3h7,Canada

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Hradec Kralove,500 02,Czechia

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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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Hvidovre,2650,Denmark

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Viborg,8800,Denmark

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Roskilde,4000,Denmark

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Esbjerg,Dk-6700,Denmark

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Paris,75012,France

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Paris,75015,France

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Paris,75013,France

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Poitiers,86021,France

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Pessac,33604,France

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Rennes,35033,France

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Oldenburg,26133,Germany

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Berlin,13353,Germany

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Hamburg,22763,Germany

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Frankfurt Am Main,Hessen,60594,Germany

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Essen,45147,Germany

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Muenchen,80636,Germany

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Dresden,Sachsen,01099,Germany

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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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Petach Tikva,4941492,Israel

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Ramat Gan,52621,Israel

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Beer Sheva,8457108,Israel

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Bologna,BO,40138,Italy

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Padova,PD,35128,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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Milano,MI,20157,Italy

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Milano,MI,20162,Italy

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Ancona,AN,60126,Italy

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Pozzilli,IS,86077,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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Vila Nova De Gaia,4434 502,Portugal

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Coimbra,3000 075,Portugal

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Salamanca,Castilla Y Leon,37007,Spain

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Valencia,Comunidad Valenciana,46010,Spain

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Madrid,28034,Spain

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Madrid,28040,Spain

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Madrid,28041,Spain

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Caceres,Extremadura,10003,Spain

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Lausanne,1011,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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Basel,4031,Switzerland

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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

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Londonderry,Bt47 1sb,United Kingdom

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Edinburgh,Ed16 4sa,United Kingdom

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Leicester,Le3 9qp,United Kingdom

University Of California San Diego

Recruiting

San Diego,California,92103-8415,United States

Taylor Buchalla

Phone: 858-246-2510

Email: tmbuchalla@health.ucsd.edu

Calvin Yeang

Icahn School of Med at Mt Sinai

Recruiting

New York,New York,10029,United States

Waqas Malick

Honey Zaw

Phone: 212-659-9174

Email: honey.zaw@mssm.edu

Virginia Heart

Recruiting

Falls Church,Virginia,22042,United States

Cynthia E Alvarez

Phone: 703-766-5920

Email: Calvarez@VirginiaHeart.com

Tariq Haddad

Henry Ford Hospital

Recruiting

Detroit,Michigan,48202,United States

Jodi Carter, BS, CCRP

Phone: 313-916-3613

Khaled Abdul-Nour

Strong Memorial Hospital

Recruiting

Rochester,New York,14642,United States

Elizabeth Anderson

Phone: 716-275-7753

Email: Elizabeth_Anderson@URMC.Rochester.edu

Robert Block

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston,Massachusetts,02115,United States

Sam Wong

Phone: 617-347-8680

Email: swong1@bwh.harvard.edu

Rhanderson Cardoso

William Beaumont Hospital

Recruiting

Royal Oak,Michigan,48073-4192,United States

Joel Skaistis

Diedra Brunk

Phone: 248-551-4192

Email: Diedre.brunk@corewellhealth.org

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

Sammy Elmariah

Malika Saxena

Phone: 415-476-8338

Email: mallika.saxena@ucsf.edu

Valley Clinical Trials

Recruiting

Northridge,California,91325,United States

Chase Miller

Phone: 818-280-4220

Email: chase@valleyclinicaltrials.com

Mehrdad Ariani

Stanford University Medical Center

Recruiting

Stanford,California,94305,United States

Abha Khandelwal

Tamara Bazouzi

Phone: 650-736-7878

Email: bazouzit@stanford.edu

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem,North Carolina,27157,United States

Judy Kennedy

Email: jkkenned@wakehealth.edu

Michael Shapiro

University Of Minnesota

Recruiting

Minneapolis,Minnesota,55455,United States

Daniel Duprez

Melanie Crawley

Phone: 612-624-4948

Email: Crawl027@umn.edu

Tufts Medical Center

Recruiting

Boston,Massachusetts,02111,United States

Benjamin Wessler

Jamie Rubinstein

Phone: 617-636-5897

Email: Jamie.Rubinstein@TuftsMedicine.org

Carient Heart and Vascular

Recruiting

Manassas,Virginia,20109,United States

Sydney Monserrate

Phone: +1 70 333 58 750

Email: smonserrate@carient.com

Vikram Prasanna

Minneapolis Heart Institute

Recruiting

Minneapolis,Minnesota,55407,United States

Haley Hanson

Phone: 612-863-3900

Email: haley.hanson@allina.com

Matthew Chu

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

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

Recruiting

Cincinnati,Ohio,45219,United States

Michael Weber

Phone: 513-585-1777

Email: michael.weber@thechristhospital.com

Sitaramesh Emani

Cardiovascular Res Found

Recruiting

Beverly Hills,California,90210,United States

Monalisa Nzenwa

Phone: 310-278-3400

Email: MonaLisa.Nzenwa@cvmg.com

Ronald P Karlsberg

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

Massachusetts General Hospital

Recruiting

Boston,Massachusetts,02114,United States

Michael Honigberg

Victoria Viscosi

Phone: 813-943-3440

Email: vviscosi@mgh.harvard.edu

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Florida,33014,United States

Alexis Gutierrez

Ariadna Mulet

Phone: 786-502-4303

Email: amulet@inpatientresearch.com

Heart Center Research Llc

Recruiting

Huntsville,Alabama,35801,United States

Anneke Miller

Phone: 256-519-8255

Email: amiller4@theheartcenter.md

Vernon R Hunter

Overlook Medical Center

Recruiting

Summit,New Jersey,07901,United States

Christine Ciprich

Phone: 908-522-6279

Email: Christine.Ciprich@atlantichealth.org

Robert Fishberg

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

Ohio State University

Recruiting

Columbus,Ohio,43210,United States

Annie Kellum

Phone: 614-685-4619

Email: annie.kellum@osumc.edu

John Larry

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Phone: 301-289-5221

Norman Lepor

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