455
Participants
Start Date
September 26, 2022
Primary Completion Date
March 5, 2025
Study Completion Date
March 5, 2025
Main cohort (Cohort A): Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Main cohort (Cohort A): Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Main cohort (Cohort A): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Main cohort (Cohort A): Matched placebo
Matched placebo subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab low dose
ponsegromab low dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort C: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Optional Cohort C: Matched placebo
Matched placebo subcutaneous injection
Optional Cohort D: Ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort D: Matched placebo
Matched placebo subcutaneous injection
Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet, Budapest
Semmelweis Egyetem, Budapest
Concord Repatriation General Hospital, Concord
The Alfred Hospital, Melbourne
The Prince Charles Hospital, Chermside
Core Research Group, Brisbane
Medifarma 98 Kft, Nyíregyháza
Lyell McEwin Hospital, Elizabeth Vale
Private Practice - Dr. Lakatos Ferenc, Békéscsaba
Somogy Vármegyei Kaposi Mór Oktató Kórház, Kaposvár
Pécsi Tudományegyetem Klinikai Központ, Pécs
Universitätsklinikum Jena, Jena
Kanizsai Dorottya Korhaz, Nagykanizsa
TaNa Med, Mosonmagyaróvár
Vseobecna fakultni nemocnice v Praze, Prague
CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña
CHUS - Hospital Clinico Universitario, Santiago de Compostela
Ustredni vojenska nemocnice, Prague
Hospital Universitario Virgen Nieves, Granada
MedStar Washington Hospital Center, Washington D.C.
University of North Carolina Medical Center, Chapel Hill
Clinical and Translational Research Center, Chapel Hill
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
Hospital Universitario Virgen de la Victoria, Málaga
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar
Emory University School of Medicine-Grady Campus, Atlanta
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen, Bad Oeynhausen
Hospital Universitario Central de Asturias, Oviedo
Eastern shore Research Institute LLC, Fairhope
Universitätsmedizin Göttingen - Georg-August-Universität, Göttingen
Hospital Universitario Virgen Del Rocio, Seville
Hospital Clinico de Valencia, Valencia
Hospital General Universitario de Valencia, Valencia
Hospital Universitari i Politecnic La Fe, Valencia
Reid Physician Associates, Richmond
Henry Ford Hospital, Detroit
Traverse Heart & Vascular, Traverse City
M Health Fairview Clinics and Surgery Center, Minneapolis
M Health Fairview University of Minnesota Investigational Drug Services, Minneapolis
M Health Fairview University of Minnesota Medical Center-East Bank, Minneapolis
University of Minnesota/Lillehei Clinical Research Unit, Minneapolis
Chicago Medical Research, Hazel Crest
Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt am Main
Washington University in St. Louis Center for Outpatient Health (COH), St Louis
Washington University in St. Louis Center for Advanced Medicine (CAM), St Louis
Washington University School of Medicine, St Louis
Saint Luke's Hospital of Kansas City, Kansas City
South Oklahoma Heart Research, LLC, Oklahoma City
Texas Health Heart & Vascular Specialist (THHVS) #18760, Dallas
Keck Medical Center of USC, Los Angeles
Peking University First Hospital, Beijing
China-Japan Union Hospital, Changchun
Zhongshan Hospital,Fudan University, Shanghai
Qilu Hospital of Shandong University, Jinan
Tianjin People' s Hospital, Tianjin
The Second Xiangya Hospital of Central South University, Changsha
The First Affiliated Hospital of University of South China, Hengyang
Guangdong Provincial People's Hospital, Guangzhou
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
Brigham and Women's Hospital, Boston
Holy Name Medical Center, Teaneck
Fraser Clinical Trials Inc, New Westminster
QEII Health Sciences Centre - Victoria General Site, Halifax
Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research, Cambridge
University Hospital - London Health Sciences Centre, London
North York Diagnostic and Cardiac Centre, North York
Private Practice - Dr. James Cha, Oshawa
Kawartha Cardiology Clinical Trials, Peterborough
Corcare, Toronto
Unity Health Toronto, St. Michael's Hospital, Toronto
Community Care Building, Winchester
Winchester District Memorial Hospital, Winchester
Institut de Cardiologie de Montreal, Montreal
Centre Hospitalier de l'Université de Montréal, Montreal
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski, Rimouski
CardioVasc HR Inc, Saint-Jean-sur-Richelieu
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur., Terrebonne
Diex Recherche Trois-Rivieres, Trois-Rivières
Yuncheng Central Hospital, Yuncheng
EDUMED - Jaroměř, Jaroměř
Institut Klinicke a Experimentalni Mediciny, Prague
Fakultni Nemocnice u sv. Anny v Brne, Brno
Fakultni nemocnice Kralovske Vinohrady, Prague
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien, Dresden
Universitätsklinikum Jena, Jena
Hyogo Prefectural Amagasaki General Medical Center, Amagasaki
Hyogo Prefectural Harima-Himeji General Medical Center, Himeji
Higashi Takarazuka Satoh Hospital, Takarazuka
Iwate Prefectural Central Hospital, Morioka
National Hospital Organization Sendai Medical Center, Sendai
Kishiwada Tokushukai Hospital, Kishiwada
National Cerebral and Cardiovascular Center, Suita
National Hospital Organization Saitama Hospital, Wako
Keio University Hospital, Shinjuku-ku
Osaka General Medical Center, Osaka
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wroclaw
Uniwersytecki Szpital Kliniczny w Białymstoku, Bialystok
Kardio Brynow, Katowice
Miejski Szpital Zespolony w Olsztynie, Olsztyn
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Lodz
Polsko Amerykanskie Kliniki Serca, Tychy
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny, Warsaw
Parc de Salut Mar - Hospital del Mar, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat
Hospital de la Santa Creu i Sant Pau, Barcelona
Wycombe General Hospital, High Wycombe
Ninewells Hospital and Medical School, Dundee
St. George's Hospital, London
Northwick Park Hospital, Harrow
Glasgow Royal Infirmary, Glasgow
Barnet Hospital, Barnet
Royal Papworth Hospital NHS Foundation Trust, Cambridge
Golden Jubilee National Hospital, Clydebank
Lincoln County Hospital, Lincoln
Liverpool University Hospitals NHS Foundation Trust, Liverpool
Northern General Hospital, Sheffield
University Hospital of North Tees, Stockton-on-Tees
Lead Sponsor
The TIMI Study Group
OTHER
Pfizer
INDUSTRY