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.

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

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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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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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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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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Roskilde,4000,Denmark

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Viborg,8800,Denmark

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Esbjerg,Dk-6700,Denmark

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Hvidovre,2650,Denmark

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Poitiers,86021,France

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Paris,75015,France

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Paris,75013,France

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Rennes,35033,France

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Pessac,33604,France

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Paris,75012,France

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Oldenburg,26133,Germany

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Berlin,13353,Germany

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Essen,45147,Germany

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Hamburg,22763,Germany

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Frankfurt Am Main,Hessen,60594,Germany

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Muenchen,80636,Germany

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Dresden,Sachsen,01099,Germany

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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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Haifa,3339419,Israel

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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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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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Amsterdam,1105 az,Netherlands

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Rotterdam,3079 dz,Netherlands

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Amsterdam,1090 hm,Netherlands

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Coimbra,3000 075,Portugal

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Vila Nova De Gaia,4434 502,Portugal

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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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Caceres,Extremadura,10003,Spain

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Madrid,28041,Spain

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Salamanca,Castilla Y Leon,37007,Spain

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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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Lausanne,1011,Switzerland

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Geneve 14,1211,Switzerland

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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

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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

University Of Minnesota

Recruiting

Minneapolis,Minnesota,55455,United States

Melanie Crawley
612-624-4948
Daniel Duprez

Henry Ford Hospital

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Detroit,Michigan,48202,United States

Khaled Abdul-Nour
Jodi Carter, BS, CCRP
313-916-3613

Tufts Medical Center

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Boston,Massachusetts,02111,United States

Jamie Rubinstein
617-636-5897
Benjamin Wessler

Valley Clinical Trials

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Northridge,California,91325,United States

Mehrdad Ariani
Chase Miller
818-280-4220

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

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Cincinnati,Ohio,45219,United States

Michael Weber
513-585-1777
Sitaramesh Emani

Carient Heart and Vascular

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Manassas,Virginia,20109,United States

Sydney Monserrate
+1 70 333 58 750
Vikram Prasanna

New York Presbyterian Hospital

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New York,New York,10021,United States

Rose Spuhler
212-746-2932
Samuel Kim

Minneapolis Heart Institute

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Minneapolis,Minnesota,55407,United States

Haley Hanson
612-863-3900
Matthew Chu

Massachusetts General Hospital

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Boston,Massachusetts,02114,United States

Michael Honigberg
Victoria Viscosi
813-943-3440

Advanced Research for Health Improvement LLC

Recruiting

Naples,Florida,34102,United States

Julian Ortiz
239-300-0586
Tracey Roth

Heart Center Research Llc

Recruiting

Huntsville,Alabama,35801,United States

Anneke Miller
256-519-8255
Vernon R Hunter

Cardiovascular Res Found

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Beverly Hills,California,90210,United States

Monalisa Nzenwa
310-278-3400
Ronald P Karlsberg

Ohio State University

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Columbus,Ohio,43210,United States

Annie Kellum
614-685-4619
John Larry

Inpatient Research Clinical LLC

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Miami Lakes,Florida,33014,United States

Alexis Gutierrez
Ariadna Mulet
786-502-4303

Icahn School of Med at Mt Sinai

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New York,New York,10029,United States

Honey Zaw
212-659-9174
Waqas Malick

University Of California San Diego

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San Diego,California,92103-8415,United States

Calvin Yeang
Taylor Buchalla
858-246-2510

Overlook Medical Center

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Summit,New Jersey,07901,United States

Christine Ciprich
908-522-6279
Robert Fishberg

Brigham and Womens Hosp Harvard Med School

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Boston,Massachusetts,02115,United States

Rhanderson Cardoso
Sam Wong
617-347-8680

Midwest Heart and Vascular Spec

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Overland Park,Kansas,66211,United States

Chelsea Waller
913-253-3000
Vasvi Singh

UC San Francisco Medical Center

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San Francisco,California,94143,United States

Malika Saxena
415-476-8338
Sammy Elmariah

National Heart Institute

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Beverly Hills,California,90211,United States

301-289-5221
Norman Lepor

Strong Memorial Hospital

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Rochester,New York,14642,United States

Elizabeth Anderson
716-275-7753
Robert Block

Perelman School of Medicine

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Philadelphia,Pennsylvania,19104,United States

Archna Bajaj
Karen Terembula

William Beaumont Hospital

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Royal Oak,Michigan,48073-4192,United States

Diedra Brunk
248-551-4192
Joel Skaistis

Wake Forest University Baptist Medical Center

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Winston-Salem,North Carolina,27157,United States

Judy Kennedy
Michael Shapiro

Stanford University Medical Center

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Stanford,California,94305,United States

Abha Khandelwal
Tamara Bazouzi
650-736-7878

Virginia Heart

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Falls Church,Virginia,22042,United States

Cynthia E Alvarez
703-766-5920
Tariq Haddad

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

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