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ACTIVE NOT RECRUITING
NCT04136171
PHASE3

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Sponsor: Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC).

Official title: A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1438

Start Date

2020-03-13

Completion Date

2026-08

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Eplontersen

Eplontersen by subcutaneous injection

DRUG

Placebo

Eplontersen-matching placebo by subcutaneous injection

Locations (142)

Mayo Clinic - Arizona

Phoenix, Arizona, United States

Altman Clinical and Translational Research Institute Center for Clinical Research

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco (UCSF) - Medical Center

San Francisco, California, United States

Stanford Hospital

Stanford, California, United States

University of Colorado Hospital - Anschutz Medical Campus

Aurora, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

Washington D.C., District of Columbia, United States

Cleveland Clinic Florida

Weston, Florida, United States

Emory Heart and Vascular Center - Emory Clifton Campus

Atlanta, Georgia, United States

Piedmont Heart of Fayetteville

Fayetteville, Georgia, United States

Northwestern University

Chicago, Illinois, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Tulane University Heart and Vascular Institute

New Orleans, Louisiana, United States

Ochsner Health System

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

New York University Langone Cardiology Associates

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Weill Cornell Medicine Cardiology

New York, New York, United States

Laurelton Heart Specialists

Rosedale, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Carl and Edyth Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

The Ohio State University College of Medicine

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical School

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Liverpool Hospital

Liverpool, New South Wales, Australia

The Westmead Institute for Medical Research

Westmead, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Advara Heartcare

Leabrook, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Advara HeartCare

Joondalup, Western Australia, Australia

Advara HeartCare Murdoch

Murdoch, Western Australia, Australia

Medizinische Universität Graz

Graz, Styria, Austria

Medizinische Universität Innsbruck

Innsbruck, Tyrol, Austria

Medizinische Universität Wien

Vienna, Austria

Ziekenhuis Oost-Limburg - Campus Sint-Jan

Genk, Limburg, Belgium

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, West-Vlaanderen, Belgium

Universidade Estadual de Campinas

Campinas, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED

Ribeirão Preto, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, Brazil

A Beneficência Portuguesa de São Paulo - Unidade Mirante

São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Instituto do Coração de São Paulo

São Paulo, Brazil

University of Calgary

Calgary, Alberta, Canada

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

University Hospital - London Health Sciences Centre

London, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Hôpital Regional de Rimouski

Rimouski, Quebec, Canada

Fakultní Nemocnice u sv. Anny v Brn

Brno, South Moravian, Czechia

Vseobecna Fakultni Nemocnice v Praze

Prague, Czechia

Institut Klinické a Experimentální Medicíny

Prague, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Hôpital Rangueil

Toulouse, Occitanie, France

Hôpitaux Universitaires Henri Mondor

Créteil, France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Hôpital de la Timone

Marseille, France

Hôpital Haut-Lévêque

Pessac, France

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Saint-Herblain, France

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Charité Campus Mitte

Berlin, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Uniklinik Koln

Cologne, Germany

Universitaetsklinikum Heidelberg - Zentrum fur Innere Medizin

Heidelberg, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Alexandra General Hospital

Athens, Greece

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Kaplan Medical Center

Rehovot, Israel

Azienda Ospedaliero Universitaria Delle Marche

Ancona, Italy

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

Bologna, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Azienda Ospedale - Università di Padova

Padua, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica

Pisa, Italy

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, Italy

Uwajima City Hospital

Uwajima-shi, Ehime, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Saiseikai Fukuoka General Hospital

Fukuoka, Hukuoka, Japan

Kokura Memorial Hospital

Kitakyushu, Hukuoka, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Kumamoto University Hospital

Kumamoto, Japan

Krakowski Szpital Specjalistyczny im. Jana Pawa II

Krakow, Poland

Narodowy Instytut Kardiologii Stefana kardyna Wyszyskiego - Pastwowy Instytut Badawczy

Warsaw, Poland

Hospital da Senhora da Oliveira - Guimarães

Guimarães, Portugal

Centro Hospitalar Universitário de Lisboa Central - Hospital de Santa Marta

Lisbon, Portugal

Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

Porto, Portugal

Centro Hospitalar Universitário de São João

Porto, Portugal

Veterans Affairs Caribbean Healthcare System

San Juan, Puerto Rico

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Skellefteå lasarett

Skellefteå, Sweden

Synexus - Scotland Clinical Research Centre

Glasgow, Scotland, United Kingdom

Synexus - Wales

Cardiff, Wales, United Kingdom

Synexus Midlands Clinical Research Centre

Edgbaston, United Kingdom

Synexus - North Tees Clinical Research Centre

Hexham, United Kingdom

Synexus - Manchester Clinical Research Centre

Liverpool, United Kingdom

Synexus - Merseyside Clinical Research Centre

Liverpool, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Richmond Pharmacology

London, United Kingdom