 Last Update: Jun 23, 2026 

 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](https://clinicaltrials.gov/ct2/show/NCT05646381)

 

Novartis Reference Number:CTQJ230A12203

 

 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 

 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 Participants502

 

 

 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



Matching placebo

 



Drug

### Pelacarsen (TQJ230) 80mg



Pelacarsen (TQJ230) 80mg

 



 

 

 

##  Eligibility Criteria 

Inclusion Criteria:

\* Male and female ≥50 to \\&lt;80 years of age at Screening Part II  
\* 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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 Israel 

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 Italy 

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 Ancona,AN,60126,Italy

 

 

 

 

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 Brescia,BS,25123,Italy

 

 

 

 

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 Pozzilli,IS,86077,Italy

 

 

 

 

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 United States 

####  Cardiovascular Res Found 

Recruiting

 Beverly Hills,California,90210,United States

 

######  Juan Ramos 

Phone: [+1 310 278 3400](<tel:+1 310 278 3400>)

Email: <juan.ramos@cvmg.com>

 

######  Ronald P Karlsberg 

 

 

 

####  National Heart Institute 

Recruiting

 Beverly Hills,California,90211,United States

 

######  Maria Flores 

Phone: [+1 301 289 5221](<tel:+1 301 289 5221>)

Email: <mflores@nationalheartinstitute.org>

 

######  Norman Lepor 

 

 

 

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Recruiting

 Northridge,California,91325,United States

 

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Phone: [+1 818 280 4220](<tel:+1 818 280 4220>)

Email: <haydee@valleyclinicaltrials.com>

 

######  Mehrdad Ariani 

 

 

 

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Recruiting

 Overland Park,Kansas,66211,United States

 

######  Elizabeth Fulks 

Phone: [+1 913 253 3000](<tel:+1 913 253 3000>)

Email: <Elizabeth.fulks@hcahealthcare.com>

 

######  Vasvi Singh 

 

 

 

####  Henry Ford Hospital 

Recruiting

 Detroit,Michigan,48202,United States

 

######  Jodi Carter, BS, CCRP 

Phone: [+1 (313) 916-3613](<tel:+1 (313) 916-3613>)

 

######  Jodi Carter 

Phone: [+1 313 590 2407](<tel:+1 313 590 2407>)

Email: <jcarte23@hfhs.org>

 

######  Khaled Abdul-Nour 

 

 

 

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Recruiting

 Summit,New Jersey,07901,United States

 

######  Robert Fishberg 

 

######  Rosmery Montesino 

Phone: [+1 908 522 6279](<tel:+1 908 522 6279>)

Email: <Rosmery.montesino@atlantichealth.org>

 

 

 

####  Virginia Heart 

Recruiting

 Falls Church,Virginia,22042,United States

 

######  Oyinda Agbale 

Phone: [+1 703 766 5920](<tel:+1 703 766 5920>)

Email: <oagbale@virginiaheart.com>

 

######  Tariq Haddad 

 

 

 

####  Carient Heart and Vascular 

Recruiting

 Manassas,Virginia,20109,United States

 

######  Hameeda Tasneem 

Phone: [+1 70 333 58 750](<tel:+1 70 333 58 750>)

Email: <htasneem@carient.com>

 

######  Vikram Prasanna 

 

 

 

####  Heart Center Research Llc 

Recruiting

 Huntsville,Alabama,35801,United States

 

######  Amy Williams 

Phone: [+1 256 519 8255](<tel:+1 256 519 8255>)

Email: <awilliams@theheartcenter.md>

 

######  Vernon R Hunter 

 

 

 

####  UC San Francisco Medical Center 

Recruiting

 San Francisco,California,94143,United States

 

######  Eveline Stock 

 

######  Liliann Zou 

Phone: [+1 415 514 3156](<tel:+1 415 514 3156>)

Email: <liliann.zou@ucsf.edu>

 

 

 

####  Tufts Medical Center 

Recruiting

 Boston,Massachusetts,02111,United States

 

######  Benjamin Wessler 

 

######  Veronique Recile 

Phone: [+1 617 636 5897](<tel:+1 617 636 5897>)

 

 

 

####  Massachusetts General Hospital 

Recruiting

 Boston,Massachusetts,02114,United States

 

######  Michael Honigberg 

 

######  Victoria Viscosi 

Phone: [+1 813 943 3440](<tel:+1 813 943 3440>)

Email: <vviscosi@mgh.harvard.edu>

 

######  Victoria Viscosi 

Email: <vviscosi@mgh.harvard.edu>

 

 

 

####  Brigham and Womens Hosp Harvard Med School 

Recruiting

 Boston,Massachusetts,02115,United States

 

######  Rhanderson Cardoso 

 

######  Sam Wong 

Phone: [+1 617 347 8680](<tel:+1 617 347 8680>)

Email: <swong1@bwh.harvard.edu>

 

######  Sam Wong 

Phone: [+1 617 525 1227](<tel:+1 617 525 1227>)

Email: <swong1@bwh.harvard.edu>

 

 

 

####  University Of Minnesota 

Recruiting

 Minneapolis,Minnesota,55455,United States

 

######  Daniel Duprez 

 

######  Michelle Pitt 

Phone: [+1 612 624 4948](<tel:+1 612 624 4948>)

Email: <henni032@umn.edu>

 

 

 

####  Icahn School of Med at Mt Sinai 

Recruiting

 New York,New York,10029,United States

 

######  Jay Krishna Katragadda 

Phone: [+1 212 659 9174](<tel:+1 212 659 9174>)

Email: <jaykrishna.katragadda@mssm.edu>

 

######  Robert Rosenson 

 

 

 

####  Perelman School of Medicine 

Recruiting

 Philadelphia,Pennsylvania,19104,United States

 

######  Archna Bajaj 

 

######  Manali Shah 

Email: <manali.shah2@pennmedicine.upenn.edu>

 

 

 

####  Strong Memorial Hospital 

Recruiting

 Rochester,New York,14642,United States

 

######  Ferogh Shakouri 

Phone: [+1 716 275 7753](<tel:+1 716 275 7753>)

Email: [ferogh\_shakouri@URMC.Rochester.edu](mailto:ferogh_shakouri@URMC.Rochester.edu)

 

######  Robert Block 

 

 

 

####  University Of California San Diego 

Recruiting

 San Diego,California,92103-8415,United States

 

######  Anna Narezkina 

 

######  Ruby Swaim 

Phone: [+1 858 246 2510](<tel:+1 858 246 2510>)

Email: <rswaim@health.ucsd.edu>

 

 

 

####  Inpatient Research Clinical LLC 

Recruiting

 Miami Lakes,Florida,33014,United States

 

######  Alexis Gutierrez 

 

######  Dora Gutierrez 

Phone: [+1 786 502 4303](<tel:+1 786 502 4303>)

Email: <dgutierrez@inpatientresearch.com>

 

 

 

####  William Beaumont Hospital 

Recruiting

 Royal Oak,Michigan,48073-4192,United States

 

######  Joel Skaistis 

 

######  Rachel Wylie 

Phone: [+1 248 551 4192](<tel:+1 248 551 4192>)

Email: <rachel.wylie@corewellhealth.org>

 

 

 

####  AA Medical Research Center 

Recruiting

 Flint,Michigan,48504,United States

 

######  Ahmed A Arif 

 

######  Fayyaz Shah 

Phone: [+1 810 237 1125](<tel:+1 810 237 1125>)

Email: <fshah@aamrc.net>

 

 

 

####  Lindner Ctr At The Christ Hosp 

Recruiting

 Cincinnati,Ohio,45219,United States

 

######  Meghan Grone 

Phone: [+1 513 585 1777](<tel:+1 513 585 1777>)

Email: <Meghan.Grone@thechristhospital.com>

 

######  Sitaramesh Emani 

 

 

 

####  Orion Medical 

Recruiting

 Houston,Texas,77034,United States

 

######  Karan Bhalla 

 

######  Lena Olivera Perez 

Email: <lena.oliveraperez@usheartandvascular.com>

 

 

 

####  Wake Forest University Baptist Medical Center 

Recruiting

 Winston-Salem,North Carolina,27157,United States

 

######  Donna Davis 

Email: <donna.h.davis@advocatehealth.org>

 

######  Michael Shapiro 

 

 

 

####  Nova Clinical Research LLC 

Recruiting

 Bradenton,Florida,34209,United States

 

######  Christian Zellner 

 

######  Sade Andrews 

Phone: [+1 941 792 6564](<tel:+1 941 792 6564>)

Email: <sade.andrews@novaclinicalresearch.com>

 

 

 

####  Flourish Clinical Resrch Covin 

Recruiting

 Covina,California,91723,United States

 

######  Fahed Bitar 

 

######  Sarita Garcia 

Phone: [+1 714 299 2412](<tel:+1 714 299 2412>)

Email: <sgarcia@flourishresearch.com>

 

 

 

####  Stanford University Medical Center 

Recruiting

 Palo Alto,California,94304,United States

 

######  Abha Khandelwal 

 

######  Tamara Bazouzi 

Phone: [+1 650 736 7878](<tel:+1 650 736 7878>)

Email: <bazouzit@stanford.edu>

 

 

 

####  Flourish Res Acq LLC North Miami 

Recruiting

 Miami,Florida,33138,United States

 

######  Ashlee Sealy 

Email: <asealy@flourishresearch.com>

 

######  Rimsky Denis 

 

 

 

####  Capital Cardiology Associates 

Recruiting

 Albany,New York,12211,United States

 

######  Lance Sullenberger 

 

######  Shreya Shah 

Email: <sshah@capitalcardiology.com>

 

 

 

####  Texas Heart Institute 

Recruiting

 Houston,Texas,77030,United States

 

######  Alexander Postalian 

 

######  Dominique Robertson 

Phone: [+1 832 355 8520](<tel:+1 832 355 8520>)

Email: <dominique.robertson@bcm.edu>

 

 

 

 

 

 

 

 

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