A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.
Who can participate
Inclusion Criteria:
* Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
* Meet criteria of either 2a or 2b:
2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.
2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.
Exclusion Criteria:
* Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 60 days before screening
* Have uncontrolled hypertension
* Have New York Heart Association class IV heart failure.
* Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
* Have severe renal failure, defined as
* Estimated glomerular rate (eGFR) \<15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
* Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
* Have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.
Interventions
Lepodisiran Sodium
DRUG
Placebo
DRUG
Locations
933
Argentina (55)
Clínica Privada del Prado SRL
Alberdi
Buenos Aires Macula S.A
Buenos Aires
Instituto Médico Especializado (IME)
Buenos Aires
Consultorio Medico Dr Litvak Bruno
Buenos Aires
Consultorio Medico Investigador Principal Dr Besada
Buenos Aires
Stat Research S.A.
Buenos Aires
Investigaciones Medicas Imoba Srl
Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
CIPREC
Buenos Aires
Fundación favaloro para la Docencia e Investigación Médica
Buenos Aires
CIPREC
Buenos Aires
CEMEDIC
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Fundación Respirar
Buenos Aires
Centro Médico Arsema
Buenos Aires
Glenny Corp. S.A.
Buenos Aires
CEDIC
CABA
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires
Instituto de Investigaciones Clínicas Córdoba
Córdoba
Sanatorio Privado Duarte Quirós
Córdoba
Centro Médico Colón
Córdoba
CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani
Córdoba
Instituto de Cardiología "Juana F. Cabral"
Corrientes
MICA - Medicina e Investigación Cardiometabólica
Del Viso
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria
Hospital Italiano de La Plata
La Plata
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Lanus
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata
Instituto de Cardiología Wolff
Mendoza
Clínica Privada Independencia
Munro
Centro Privado de Medicina Respiratoria
Paraná
CER medical Institute
Quilmes
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Quilmes
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Río Cuarto
Fundacion Estudios Clinicos
Rosario
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Rosario
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Toronto
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China (64)
Beijing Chaoyang Hospital, Capital Medical University
Beijing
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The First Hospital of Jilin University
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The Third Xiangya Hospital of Central South University
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Tianjin
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Xi'an
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Xiamen
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Yinchuan
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Yueyang
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Zhengzhou
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Zigong
Czech Republic (22)
MEDICUS SERVICES s.r.o., kardiologicka ambulance
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Zlín
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Sygehus Sønderjylland i Aabenraa
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Hôpital Avicenne
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Centre Hospitalier Saint Joseph - Saint Luc
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Centre Hospitalier Universitaire de Nice - Hopital Pasteur
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Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
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Pitie Salpetriere University Hospital
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Hôpital Européen Georges Pompidou
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Mannheim
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Munich
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Münster
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Potsdam
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National Cerebral and Cardiovascular Center
Suita
Medical Corporation Heishinkai OCROM Clinic
Suita-shi
Shizuoka Medical Center
Sunto-gun
Kagawa Prefectural Central Hospital
Takamatsu
Higashi Takarazuka Satoh Hospital
Takarazuka
Takasago Seibu Hospital
Takasago
Osaka Medical and Pharmaceutical University Hospital
Takatsuki
Sekino Hospital
Toshimaku
Toyama University Hospital
Toyoma
Tsuchiura Kyodo General Hospital
Tsuchiura
National Hospital Organization Shinshu Ueda Medical Center
Ueda
Saiseikai Yokohamashi Tobu Hospital
Yokohama
Yokosukakyosai
Yokosuka
Mexico (42)
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes
Hospital Cardiologica Aguescalientes
Aguascalientes
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara
Diseno y Planeacion en Investigacion Medica
Guadalajara
Centro de Investigacion Medica Integral
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
Guadalajara
Virgen Cardiovascular Research SC
Guadalajara
CINVEC Medica
Guadalajara
Investigación Médica Sonora, S.C.
Hermosillo
Instituto Cardiovascular de León S.C.
León
Medical Care and Research SA de CV
Mérida
Clinstile, S.A. de C.V.
México
RM Pharma Specialists
Mexico City
Clínicos Asociados BOCM
Mexico City
Grupo Medico Camino Sc
Mexico City
Hospital de Jésus, I.A.P.
Mexico City
Clinica Omega
Mexico City
Centro Médico Nacional Siglo XXI
Mexico City
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City
ProcliniQ Investigación Clínica SA de CV
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
Accelerium Clinical Research
Monterrey
Cardiolink Clin Trials
Monterrey
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey
UBAM Unidad Biomedica Avanzada Monterrey
Monterrey
Clínica García Flores SC
Monterrey
Centro de investigación y control metabólico
Monterrey
Clinica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro
PanAmerican Clinical Research - Querétaro - Avenida Antea
Querétaro
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí City
Servicios Integrales Nova de Monterrey S.A. de C.V.
San Nicolás de los Garza
Centro de Investigacion Cardiovascular y Metabólica
Tijuana
Medimanage Research
Tlalpan
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz
Hospital Angeles Xalapa
Xalapa
Netherlands (30)
Meander Medisch Centrum
Amersfoort
Amsterdam UMC, locatie AMC
Amsterdam
Gelre Ziekenhuis
Apeldoorn
Rode Kruis Ziekenhuis
Beverwijk
Reinier de Graaf Ziekenhuis, locatie Delft
Delft
Deventer Ziekenhuis
Deventer
Slingeland Ziekenhuis
Doetinchem
Ziekenhuis Gelderse Vallei
Ede
Catharina Ziekenhuis
Eindhoven
Admiraal de Ruyter Ziekenhuis, locatie Goes
Goes
Groene Hart Ziekenhuis
Gouda
General Practitioners Research Institute (GPRI)
Groningen
Martini Ziekenhuis
Groningen
Spaarne Gasthuis, Haarlem Zuid
Haarlem
Saxenburgh Medisch Centrum
Hardenberg
Ziekenhuis St. Jansdal
Harderwijk
Tergooiziekenhuizen, locatie Hilversum
Hilversum
Medische Centrum Leeuwarden
Leeuwarden
Leids Universitair Medisch Centrum
Leiden
Radboudumc
Nijmegen
Bravis Ziekenhuis, locatie Roosendaal
Roosendaal
Erasmus Medisch Centrum
Rotterdam
Ikazia Ziekenhuis
Rotterdam
Antonius Ziekenhuis, locatie D&A Research and Genetics
Sneek
Haga Ziekenhuis locatie Leyweg
The Hague
ETZ TweeSteden
Tilburg
Universitair Medisch Centrum Utrecht
Utrecht
Maxima Medisch Centrum, locatie Veldhoven
Veldhoven
VieCuri Medisch Centrum, locatie Venlo
Venlo
Zaans Medisch Centrum
Zaandam
Poland (31)
Specderm Poznanska sp.j.
Bialystok
NZOZ Centrum Medyczne KERmed
Bydgoszcz
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz
Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo-Naczyniowe
Chrzanów
Polsko-Amerykańskie Kliniki Serca
Dąbrowa Górnicza
Centrum Kliniczno-Badawcze
Elblag
NZOZ Twoje Zdrowie EL Sp. z o. o.
Elblag
Uniwersyteckie Centrum Kliniczne
Gdansk
Przychodnie Grudziądz
Grudziądz
NZOZ Salvia CM
Katowice
Polsko-Amerykańskie Kliniki Serca
Kędzierzyn-Koźle
Centrum Medyczne Linden
Krakow
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow
Poliklinika Kardiologiczna Serce
Leszno
Centra Medyczne Medyceusz
Lodz
Pro Salus Centrum Medyczne
Lodz
Instytut Centrum Zdrowia Matki Polki
Lodz
Clinical Best Solutions
Lublin
1 Wojskowy Szpital Kliniczny w Lublinie
Lublin
CenterMed Lublin NZOZ
Lublin
Private Practice - Dr. Michał Tomaszewski
Lublin
Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli
Nowa Sól
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl
AKA-MED Centrum
Ruda Śląska
Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Żabówka E. Żabówka
Tarnów
Polsko-Amerykańskie Kliniki Serca
Tychy
Clinical Best Solutions
Warsaw
Balsam Medica
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw
NZOZ Centurm Medyczne SERAFIN-MED
Żarów
Puerto Rico (2)
Advanced Clinical Research, LLC
Bayamón
GCM Medical Group, PSC - Hato Rey Site
San Juan
Romania (23)
CMI Cardiologie - Dr. Mercea Corina Delia
Baia Mare
CMI DNBM Dr. Pop Lavinia
Baia Mare
C.M.D.T.A. Neomed
Brasov
Nicodiab
Bucharest
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
Bucharest
Centrul Medical NutriLife
Bucharest
Spitalul Universitar de Urgență București
Bucharest
Centrul Medical Endocrinologie si Diabet Dr. Paveliu
Bucharest
Mat Cord Biomedica S.R.L.
Buzău
Spitalul Clinic Județean de Urgență
Craiova
Milena Sante
Galați
Diamed Obesity
Galați
Centrul Medical Consultmed
Iași
Cardiomed Iași
Iași
Clinica Korall
Satu Mare
Policlinica Astra Sibiu
Sibiu
Cardiomed
Târgu Mureş
Centrul Medical Mediab
Târgu Mureş
Mediab S.R.L.
Târgu Mureş
Private Practice - Dr. Cristian Podoleanu
Târgu Mureş
SC Dentosim Queen SRL - Centrul Medical Diamed
Târgu Mureş
Cabinet Medical Dr.Geru
Timișoara
Institutul de Boli Cardiovasculare Timișoara
Timișoara
Slovakia (14)
Cliniq s.r.o.
Bratislava
ENDIAMED s.r.o
Dolný Kubín
JM-Interna s.r.o
Dolný Kubín
NEDÚ - Národný endokrinologický a diabetologický ústav n.o.
Ľubochňa
IN-DIA
Lučenec
Sin Azucar
Malacky
AMBORA s.r.o. Interna ambulancia
Martin
Fakultná nemocnica Nitra
Nitra
MEDIKALS
Piešťany
MEDISPOL
Prešov
ENRIN, s.r.o.
Rimavská Sobota
Tatratrial s.r.o.
Rožňava
Areteus s.r.o.
Trebišov
MediPrax, s.r.o.
Trstená
South Korea (20)
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Hospital
Daegu
Eulji University Hospital
Daejeon
Boramae Medical Center
Dongjak-gu
Chonnam National University Hospital
Gwangju
Gachon University Gil Medical Center
Namdong-gu
Seoul National University Bundang Hospital
Seongnam
Kyung Hee University Hospital
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Asan Medical Center
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Sejong General Hospital
Sosa-gu
The Catholic University Of Korea St. Vincent's Hospital
Suwon
Ulsan University Hospital
Ulsan
Spain (43)
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital Universitario Fundacion ALcorcon
Alcorcón
Hospital Germans Trias i Pujol
Badalona
Parc de Salut Mar - Hospital del Mar
Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital de Denia Marina Salud
Denia
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol
Hospital de Cabueñes
Gijón
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Hospital Universitario Virgen Nieves
Granada
Hospital Infanta Elena
Huelva
Hospital Universitario de Jaen
Jaén
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria
Hospital Lucus Augusti
Lugo
FutureMeds - Madrid
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitari Son Espases
Palma
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón
Salut Sant Joan de Reus-Baix Camp (Edp)
Reus
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca
Hospital Virgen del Camino
Sanlúcar de Barrameda
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí
Hospital Universitario Marqués de Valdecilla
Santander
CHUS - Hospital Clinico Universitario
Santiago de Compostela
Hospital General de Segovia
Segovia
Hospital Universitario Virgen Macarena
Seville
FutureMeds - Sevilla
Seville
Hospital Universitario Virgen Del Rocio
Seville
Vithas Hospital Sevilla
Seville
Hospital Clinico de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Arnau de Vilanova
Valencia
Hospital Virgen de las Montañas
Villamartín
Hospital Universitario Miguel Servet
Zaragoza
Taiwan (15)
Changhua Christian Hospital
Changhua County
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist
Fu Jen Catholic University Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Chi Mei Medical Center
Tainan
National Taiwan University Hospital
Taipei
Cathay General Hospital
Taipei
Taipei Medical University Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
National Yang Ming Chiao Tung University Hospital
Yilan
United Kingdom (17)
Layton Medical Centre
Blackpool
Bristol Royal Infirmary
Bristol
Cheadle Community Hospital
Cheadle
Panthera Biopartners - North London
Enfield
Panthera Biopartners - Glasgow
Glasgow
Hull Royal Infirmary
Hull
Royal Free Hospital
London
Royal Victoria Infirmary
Newcastle upon Tyne
Panthera Biopartners - Preston
Preston
Panthera Biopartners - Manchester
Rochdale
Salford Royal Hospital
Salford
Panthera Biopartners - Sheffield
Sheffield
Lister Hospital
Stevenage
Torbay Hospital
Torquay
Sunderland Royal Hospital
Tyne and Wear
Sandwell General Hospital
West Bromwich
Panthera Clinic - York
York
United States (222)
American Clinical Trials - Acworth
Acworth , Georgia
Albany Medical College, Division of Community Endocrinology
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