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NCT05646381PHASE2Recruiting

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Novartis Pharmaceuticals

Start Date

3/7/2024

Completion Date

3/12/2030

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.

Eligibility Criteria

Age Range: 50 years to 80 years

Inclusion Criteria: * Male and female ≥50 to \<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

Interventions

DRUG

Pelacarsen (TQJ230) 80mg

DRUG

Matching placebo

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Conditions

Aortic Stenosis

Locations

Heart Center Research Llc

Huntsville, Alabama 35801

United States

Cardiovascular Res Found

Beverly Hills, California 90210

United States

National Heart Institute

Beverly Hills, California 90211

United States

Flourish Clinical Resrch Covin

Covina, California 91723

United States

Valley Clinical Trials

Northridge, California 91325

United States

Stanford University Medical Center

Palo Alto, California 94304

United States

University Of California San Diego

San Diego, California 92103-8415

United States

UC San Francisco Medical Center

San Francisco, California 94143

United States

Excel Medical Clinical Trials LLC

Boca Raton, Florida 33434

United States

Nova Clinical Research LLC

Bradenton, Florida 34209

United States

Flourish Res Acq LLC North Miami

Miami, Florida 33138

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

Advanced Research for Health Improvement LLC

Naples, Florida 34102

United States

Midwest Heart and Vascular Spec

Overland Park, Kansas 66211

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts 02115

United States

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts 02115

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

AA Medical Research Center

Flint, Michigan 48504

United States

William Beaumont Hospital

Royal Oak, Michigan 48073-4192

United States

Minneapolis Heart Institute

Minneapolis, Minnesota 55407

United States

University Of Minnesota

Minneapolis, Minnesota 55455

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Capital Cardiology Associates

Albany, New York 12211

United States

New York Presbyterian Hospital

New York, New York 10021

United States

Icahn School of Med at Mt Sinai

New York, New York 10029

United States

Strong Memorial Hospital

Rochester, New York 14642

United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

Lindner Ctr At The Christ Hosp

Cincinnati, Ohio 45219

United States

Ohio State University

Columbus, Ohio 43210

United States

Perelman School of Medicine

Philadelphia, Pennsylvania 19104

United States

Texas Heart Institute

Houston, Texas 77030

United States

Orion Medical

Houston, Texas 77034

United States

Virginia Heart

Falls Church, Virginia 22042

United States

Carient Heart and Vascular

Manassas, Virginia 20109

United States

Novartis Investigative Site

Innsbruck, Tyrol 6020

Austria

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Linz, 4021

Austria

Novartis Investigative Site

Vienna, 1100

Austria

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Vienna, 1190

Austria

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Vienna, A 1090

Austria

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Genk, Limburg 3600

Belgium

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Yvoir, Namur 5530

Belgium

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Aalst, Oost Vlaanderen 9300

Belgium

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Kortrijk, West-Vlaanderen 8500

Belgium

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Roeselare, West-Vlaanderen 8800

Belgium

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Cambridge, Ontario N1R 6V6

Canada

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North York, Ontario M6B 3H7

Canada

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Ottawa, Ontario K1Y 4W7

Canada

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Montreal, Quebec H1T 1C8

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Montreal, Quebec H3T 1E2

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Montreal, Quebec H4A 3J1

Canada

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Québec, Quebec G1V 4G5

Canada

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Hradec Králové, 500 02

Czechia

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Jaroměř, 551 01

Czechia

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Prague, 128 08

Czechia

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Prague, 14021

Czechia

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Prague, 150 06

Czechia

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Esbjerg, 6700

Denmark

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Hvidovre, 2650

Denmark

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Roskilde, 4000

Denmark

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Viborg, 8800

Denmark

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Paris, 75012

France

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Paris, 75013

France

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Paris, 75015

France

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Pessac, 33604

France

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Poitiers, 86021

France

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Rennes, 35033

France

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Frankfurt am Main, Hesse 60594

Germany

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Kaiserslautern, Rhineland-Palatinate 67655

Germany

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Dresden, Saxony 01099

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Leipzig, Saxony 04289

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Ahaus, 48683

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Berlin, 13353

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Bonn, 53105

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Essen, 45147

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Hamburg, 20246

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Hamburg, 22763

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Lüneburg, 21339

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Mannheim, 68165

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München, 80636

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Münster, 48149

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Oldenburg, 26133

Germany

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Beersheba, 8457108

Israel

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Haifa, 3104802

Israel

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Haifa, 3109601

Israel

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Jerusalem, 9103102

Israel

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Jerusalem, 9112001

Israel

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Nahariya, 2210001

Israel

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Petah Tikva, 4941492

Israel

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Ramat Gan, 5265601

Israel

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Tel Aviv, 6423906

Israel

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Ancona, AN 60126

Italy

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Bergamo, BG 24127

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Bologna, BO 40138

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Brescia, BS 25123

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Caserta, CE 81100

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Cona, FE 44124

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Pozzilli, IS 86077

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Milan, MI 20138

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Milan, MI 20157

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Milan, MI 20162

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Padova, PD 35128

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Pordenone, PN 33170

Italy

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Amsterdam, North Holland 1090 HM

Netherlands

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Amsterdam, North Holland 1105 AZ

Netherlands

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Rotterdam, South Holland 3015 GD

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Rotterdam, South Holland 3079 DZ

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Nieuwegein, Utrecht 3435 CM

Netherlands

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Alcabideche, 2755-009

Portugal

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Braga, 4710243

Portugal

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Coimbra, 3004-561

Portugal

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Vila Nova de Gaia, 4434 502

Portugal

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Cáceres, Extremadura 10003

Spain

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Córdoba, 14004

Spain

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Madrid, 28034

Spain

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Madrid, 28040

Spain

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Madrid, 28041

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Madrid, 28046

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Salamanca, 37007

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Valencia, 46010

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Basel, 4031

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Geneva, 1211

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Lausanne, 1011

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Lugano, 6900

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Zurich, 8091

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Reading, Berkshire RG1 5AN

United Kingdom

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Portadown, Nothern Ireland BT63 5QQ

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Edinburgh, EH16 4SA

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Leicester, LE3 9QP

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Liverpool, L14 3PE

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London, EC1A 7BE

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London, SE1 7EH

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Londonderry, BT47 6SB

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Manchester, M23 9LT

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Middlesbrough, TS4 3BW

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Norwich, NR4 7UY

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Novartis Investigative Site

Tyne and Wear, NE29 8NH

United Kingdom