Last Update: Aug 09, 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:
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
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

Study Location

Novartis Investigative Site

Recruiting

Wien,1190,Austria

Novartis Investigative Site

Recruiting

Montreal,Quebec,H3t 1e2,Canada

Novartis Investigative Site

Recruiting

Sainte Foy,Quebec,G1v 4g5,Canada

Novartis Investigative Site

Recruiting

North York,Ontario,M6b 3h7,Canada

Novartis Investigative Site

Recruiting

Jaromer Budova Polikliniky,551 01,Czechia

Novartis Investigative Site

Recruiting

Prague 2,128 08,Czechia

Novartis Investigative Site

Recruiting

Praha 4,Czech Republic,140 21,Czechia

Novartis Investigative Site

Recruiting

Esbjerg,Dk-6700,Denmark

Novartis Investigative Site

Recruiting

Viborg,Dk-8800,Denmark

Novartis Investigative Site

Recruiting

Muenchen,80636,Germany

Novartis Investigative Site

Recruiting

Ramat Gan,52621,Israel

Novartis Investigative Site

Recruiting

Haifa,3339419,Israel

Novartis Investigative Site

Recruiting

Nahariya,22100,Israel

Novartis Investigative Site

Recruiting

Beer Sheva,8457108,Israel

Novartis Investigative Site

Recruiting

Jerusalem,9112001,Israel

Novartis Investigative Site

Recruiting

Petach Tikva,49100,Israel

Novartis Investigative Site

Recruiting

Torrette Ancona,AN,60126,Italy

Novartis Investigative Site

Recruiting

Brescia,BS,25123,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20138,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20157,Italy

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Madrid,28040,Spain

Novartis Investigative Site

Recruiting

Madrid,28041,Spain

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46010,Spain

Novartis Investigative Site

Recruiting

Basel,4031,Switzerland

Novartis Investigative Site

Recruiting

Zuerich,8091,Switzerland

Novartis Investigative Site

Recruiting

Lugano,6903,Switzerland

Novartis Investigative Site

Recruiting

Geneve 14,1211,Switzerland

Novartis Investigative Site

Recruiting

Middlesbrough,Ts4 3bw,United Kingdom

Novartis Investigative Site

Recruiting

Tyne And Wear,Ne29 8nh,United Kingdom

Novartis Investigative Site

Recruiting

London,Ec14 7be,United Kingdom

Novartis Investigative Site

Recruiting

Edinburgh,Ed16 4sa,United Kingdom

Novartis Investigative Site

Recruiting

London,Se1 7eh,United Kingdom

Carient Heart and Vascular

Recruiting

Manassas,Virginia,20109,United States

Nazish Khan
+1 70 333 58 750
Vikram Prasanna

New York Presbyterian Hospital Weill Cornell Med Ctr

Recruiting

New York,New York,10021,United States

Samuel Kim
212-746-2932

Advanced Research for Health Improvement LLC

Recruiting

Naples,Florida,34102,United States

Julian Ortiz
239-300-0586
Tracey Roth

Virginia Heart

Recruiting

Falls Church,Virginia,22042,United States

Christina Good
703-766-5920
Tariq Haddad

Henry Ford Hospital

Recruiting

Detroit,Michigan,48202,United States

Khaled Abdul-Nour
Kayla A Baker
313-916-3502

Midwest Heart and Vascular Spec

Recruiting

Overland Park,Kansas,66211,United States

Chelsea Waller
913-253-3000
Vasvi Singh

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

David Funt
Yoelis Deleon
561-756-8206

Ohio State University Heart and Vascular Res Org

Recruiting

Columbus,Ohio,43210,United States

Annie Kellum
614-685-4619
John Larry

Brigham and Womens Hosp Harvard Med School .

Recruiting

Boston,Massachusetts,02115,United States

Camila Souza Freire
617-525-1227
Rhanderson Cardoso

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Maria Flores
301-289-5221
Norman Lepor

Heart Center Research Llc .

Recruiting

Huntsville,Alabama,35801,United States

Carolyn Keefer
256-519-8255
Vernon R Hunter

Overlook Medical Center

Recruiting

Summit,New Jersey,07901,United States

Kristal Mendoza
908-522-6279
Robert Fishberg

Cardiovascular Res Found

Recruiting

Beverly Hills,California,90210,United States

Monalisa Nzenwa
310-278-3400
Ronald P Karlsberg

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682