Last Update: Oct 01, 2024
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:
Novartis Reference Number:CTQJ230A12203
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
Jan 03, 2029
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

Recruiting

Wien,1190,Austria

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Wien,A 1090,Austria

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Montreal,Quebec,H3t 1e2,Canada

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Sainte Foy,Quebec,G1v 4g5,Canada

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North York,Ontario,M6b 3h7,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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Roskilde,4000,Denmark

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Viborg,Dk-8800,Denmark

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Esbjerg,Dk-6700,Denmark

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Hvidovre,2650,Denmark

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Paris 13,75651,France

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Paris,75015,France

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Frankfurt,60594,Germany

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Hamburg,22763,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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Nahariya,22100,Israel

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Beer Sheva,8457108,Israel

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Haifa,3339419,Israel

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Petach Tikva,4941492,Israel

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Jerusalem,9112001,Israel

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Ramat Gan,52621,Israel

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Milano,MI,20162,Italy

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Ancona,AN,60126,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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Milano,MI,20157,Italy

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Vila Nova De Gaia,4434 502,Portugal

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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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Madrid,28034,Spain

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Madrid,28040,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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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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Edinburgh,Ed16 4sa,United Kingdom

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Leicester,Le3 9qp,United Kingdom

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Maria Flores
Norman Lepor

Henry Ford Hospital

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Detroit,Michigan,48202,United States

Kayla A Baker
Khaled Abdul-Nour

Virginia Heart

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Falls Church,Virginia,22042,United States

Tariq Haddad
Christina Good

Advanced Research for Health Improvement LLC

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Naples,Florida,34102,United States

Tracey Roth
Julian Ortiz

New York Presbyterian Hospital Weill Cornell Med Ctr

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New York,New York,10021,United States

Samuel Kim

Carient Heart and Vascular

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Manassas,Virginia,20109,United States

Sydney Monserrate
Vikram Prasanna

Midwest Heart and Vascular Spec

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Overland Park,Kansas,66211,United States

Chelsea Waller
Vasvi Singh

Wake Forest University Baptist Medical Center Wake Forest

Recruiting

Winston-Salem,North Carolina,27157,United States

Judy Kennedy
Michael Shapiro

Valley Clinical Trials

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Northridge,California,91325,United States

Mehrdad Ariani
Valeria Gutierrez

Minneapolis Heart Institute

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Minneapolis,Minnesota,55407,United States

Haley Hanson
Matthew Chu

Heart Center Research Llc .

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Huntsville,Alabama,35801,United States

Carolyn Keefer
Vernon R Hunter

Massachusetts General Hospital Massachusetts General Hospital

Recruiting

Boston,Massachusetts,02114,United States

Michael Honigberg

Ohio State University Heart and Vascular Res Org

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Columbus,Ohio,43210,United States

Annie Kellum
John Larry

Excel Medical Clinical Trials LLC

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Boca Raton,Florida,33434,United States

David Funt
Yoelis Deleon

Overlook Medical Center

Recruiting

Summit,New Jersey,07901,United States

Kristal Mendoza
Robert Fishberg

Cardiovascular Res Found

Recruiting

Beverly Hills,California,90210,United States

Monalisa Nzenwa
Ronald P Karlsberg

Brigham and Womens Hosp Harvard Med School .

Recruiting

Boston,Massachusetts,02115,United States

Camila Souza Freire
Rhanderson Cardoso

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