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A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: 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]
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
502
Start Date
2024-03-07
Completion Date
2030-03-12
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
Matching placebo
Matching placebo
Locations (136)
Heart Center Research Llc
Huntsville, Alabama, United States
Cardiovascular Res Found
Beverly Hills, California, United States
National Heart Institute
Beverly Hills, California, United States
Flourish Clinical Resrch Covin
Covina, California, United States
Valley Clinical Trials
Northridge, California, United States
Stanford University Medical Center
Palo Alto, California, United States
University Of California San Diego
San Diego, California, United States
UC San Francisco Medical Center
San Francisco, California, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Nova Clinical Research LLC
Bradenton, Florida, United States
Flourish Res Acq LLC North Miami
Miami, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Advanced Research for Health Improvement LLC
Naples, Florida, United States
Midwest Heart and Vascular Spec
Overland Park, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
AA Medical Research Center
Flint, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Overlook Medical Center
Summit, New Jersey, United States
Capital Cardiology Associates
Albany, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Icahn School of Med at Mt Sinai
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Lindner Ctr At The Christ Hosp
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Orion Medical
Houston, Texas, United States
Virginia Heart
Falls Church, Virginia, United States
Carient Heart and Vascular
Manassas, Virginia, United States
Novartis Investigative Site
Innsbruck, Tyrol, Austria
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Linz, Austria
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Vienna, Austria
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Vienna, Austria
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Genk, Limburg, Belgium
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Yvoir, Namur, Belgium
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Aalst, Oost Vlaanderen, Belgium
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Kortrijk, West-Vlaanderen, Belgium
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Roeselare, West-Vlaanderen, Belgium
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Cambridge, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Hradec Králové, Czechia
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Jaroměř, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Esbjerg, Denmark
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Hvidovre, Denmark
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Roskilde, Denmark
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Viborg, Denmark
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Paris, France
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Paris, France
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Paris, France
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Pessac, France
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Poitiers, France
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Rennes, France
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Frankfurt am Main, Hesse, Germany
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Kaiserslautern, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Ahaus, Germany
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Berlin, Germany
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Bonn, Germany
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Essen, Germany
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Hamburg, Germany
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Hamburg, Germany
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Lüneburg, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Oldenburg, Germany
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Beersheba, Israel
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Haifa, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Ancona, AN, Italy
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Brescia, BS, Italy
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Caserta, CE, Italy
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Cona, FE, Italy
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Pozzilli, IS, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Padova, PD, Italy
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Pordenone, PN, Italy
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Amsterdam, North Holland, Netherlands
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Amsterdam, North Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Nieuwegein, Utrecht, Netherlands
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Alcabideche, Portugal
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Braga, Portugal
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Coimbra, Portugal
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Vila Nova de Gaia, Portugal
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Cáceres, Extremadura, Spain
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Córdoba, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Salamanca, Spain
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Valencia, Spain
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Basel, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Lugano, Switzerland
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Zurich, Switzerland
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Portadown, Nothern Ireland, United Kingdom
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Edinburgh, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Londonderry, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Tyne and Wear, United Kingdom