A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— LIBREXIA-ACS  

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754957
• Other study ID #: CR109271
• Secondary ID: 70033093ACS30032
• Status: Recruiting
• Phase: Phase 3
• Start date: April 7, 2023
• Est. completion date: October 19, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: October 19, 2026
• Est. primary completion date: September 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory

• Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)

• All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening

• A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention

Exclusion Criteria:

• MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event

• Planned CABG or staged PCI after randomization

• Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines

• Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Milvexian
Milvexian will be administered orally.

Other:
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional Del Sur	Bahia Blanca
Argentina	Sanatorio Finochietto	Buenos Aires
Argentina	Sanatorio Guemes	Caba
Argentina	Centro Medico Dra. Laura Maffei - Investigacion Clinica Aplicada	Ciudad Autonoma Buenos Aires
Argentina	Clinica Adventista Belgrano	Ciudad Autonoma Buenos Aires
Argentina	Fundacion Favaloro	Ciudad Autonoma Buenos Aires
Argentina	Instituto Cardiovascular de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma de Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma de Buenos Aires
Argentina	Centro Medico Luquez	Cordoba
Argentina	Clínica Chutro	Cordoba
Argentina	Hospital Cordoba	Cordoba
Argentina	Hospital San Roque	Cordoba
Argentina	Sanatorio Allende	Cordoba
Argentina	Sanatorio de la Canada	Cordoba
Argentina	Sanatorio Duarte Quiroz	Cordoba
Argentina	Clinica Coronel Suarez	Coronel Suarez
Argentina	Hospital El Cruce	Florencio Varela
Argentina	Hospital Italiano de La Plata	La Plata
Argentina	Centro de Investigaciones Medicas Mar Del Plata	Mar del Plata
Argentina	Hospital Italiano Garibaldi	Rosario
Argentina	Hospital Provincial del Centenario	Rosario
Argentina	Instituto Cardiovascular de Rosario	Rosario
Argentina	Sanatorio Parque	Rosario
Argentina	Centro Cardiovascular Salta	Salta
Argentina	Centro de Investigaciones Clinicas Salta	Salta
Argentina	Corporacion Medica de Gral. San Martin S.A.	San Martin
Argentina	Investigaciones Clinicas Tucuman	San Miguel de Tucuman
Argentina	Estudios Clinicos de los Arroyos	San Nicolas
Argentina	Hospital José María Cullen	Santa Fe
Argentina	Sanatorio Mayo SA	Santa Fe
Argentina	Sanatorio Medico de Diagnostico y Tratamiento	Santa Fe
Argentina	Sanatorio San Martin	Venado Tuerto
Argentina	Clinica Privada Fusavim SRL	Villa Maria
Australia	Flinders Medical Centre	Adelaide
Australia	Ballarat Base Hospital	Ballarat
Australia	Sunshine Coast University Hospital	Birtinya
Australia	Cairns Base Hospital	Cairns
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Concord Repatriation General Hospital	Concord
Australia	Royal Brisbane and Women's Hospital	Herston
Australia	Royal Hobart Hospital	Hobart
Australia	Nepean Hospital	Kingswood
Australia	Core Research Group	Milton
Australia	Fiona Stanley Hospital	Murdoch
Austria	KH St.Josef Braunau am Inn	Braunau am Inn
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	LKH-Univ. Klinikum Graz	Graz
Austria	Krankenhaus der Elisabethinen Linz	Linz
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ Klina	Brasschaat
Belgium	AZ Sint-Jan	Brugge
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	C.H.U. Brugmann	Bruxelles
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	CUB Hôpital Erasme	Bruxelles
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	AZ Sint-Lucas	Gent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHR de la Citadelle	Liege
Belgium	Az Sint-Maarten	Mechelen
Belgium	Heilig Hart Ziekenhuis Lier	Mol
Belgium	AZ Delta	Roeselare
Belgium	AZ Turnhout	Turnhout
Brazil	Cardresearch - Cardiologia Assistencial	Belo Horizonte
Brazil	Hospital Vera Cruz	Belo Horizonte
Brazil	Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa	Belo Horizonte
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu
Brazil	Centro de Cardiologia Clinica e Pesquisa Doutora Juliana Souza Ltda. - CECAP Centro de Cardiologia Clinica	Brasilia
Brazil	Hospital do Coracao do Brasil	Brasilia
Brazil	Sociedade Hospitalar Angelina Caron	Campina Grande Do Sul
Brazil	C.E.C.-Centro Especializado em Cardiologia Ltda.- Loema Medicina e Bem Estar	Campinas
Brazil	Instituto de Pesquisa Clinica de Campinas	Campinas
Brazil	Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose	Criciúma
Brazil	Associacao Paranaense de Cultura PUCPR	Curitiba
Brazil	Hospital Cardiológico Costantini	Curitiba
Brazil	Irmandade Santa Casa de Misericordia de Curitiba	Curitiba
Brazil	Hospital Das Clinicas Da Universidade Federal De Goias	Goiania
Brazil	Instituto do Coracao de Marília	Marilia
Brazil	Instituto Atena de Pesquisa Clinica	Natal
Brazil	Instituto Mederi de Pesquisa e Saude	Passo Fundo
Brazil	Santa Casa de Misericordia de Pelotas	Pelotas
Brazil	Hospital Maternidade e Pronto Socorro Santa Lucia	Poços de Caldas
Brazil	Associacao Hospitalar Moinhos de Vento	Porto Alegre
Brazil	Fundacao Universitaria de Cardiologia	Porto Alegre
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital Ernesto Dornelles	Porto Alegre
Brazil	IMV Pesquisa Cardiologica Sociedade Simples HMD COR l	Porto Alegre
Brazil	Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS	Porto Alegre
Brazil	PROCAPE - Universidade de Pernambuco Pronto Socorro Cardiológico de Pernambuco prof Luiz Tavares	Recife
Brazil	Secretaria de Saude Hospital Agamenon Magalhaes	Recife
Brazil	Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP	Ribeirao Preto
Brazil	Hospital sao lucas	Rio de Janeiro
Brazil	Fundacao Bahiana de Cardiologia	Salvador
Brazil	Hospital da Bahia	Salvador
Brazil	Hospital Santa Izabel Santa Casa de Misericordia da Bahia	Salvador
Brazil	Instituto CardioPulmonar	Salvador
Brazil	Pesquisare Saude	Santo Andre
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	Sao Bernardo Do Campo
Brazil	Instituto de Cardiologia de Santa Catarina	São José
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base	Sao Jose do Rio Preto
Brazil	Casa de Saude Santa Marcelina - Hospital Santa Marcelina	Sao Paulo
Brazil	FGM Clinica Paulista de Doencas Cardiovasculares Ltda	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo
Brazil	Hospital Das Clinicas Da Faculdade De Medicina Da USP	Sao Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Brazil	Irmandade Da Santa Casa De Misericordia De Sao Paulo	Sao Paulo
Brazil	Real e Benemerita Associacao Portuguesa de Beneficencia	Sao Paulo
Brazil	Instituto de Moléstias Cardiovasculares Tatuí	Tatuí
Brazil	HC-UFTM - Hospital de Clínicas da Universidade Federal do Triângulo Mineiro	Uberaba
Brazil	Clinica Cardioped Ltda	Vitoria
Brazil	CEDOES	Vitória
Brazil	Santa Casa de Misericórdia de Votuporanga	Votuporanga
Bulgaria	MHAT Puls	Blagoevgrad
Bulgaria	MHAT Heart and Brain	Burgas
Bulgaria	Multiprofile Hospital for Active Treatment Dr. Tota Venkova	Gabrovo
Bulgaria	Multiprofile Hospital for Active Treatment - Haskovo	Haskovo
Bulgaria	MHAT Uni Hospital	Panagyurishte
Bulgaria	SHATC Sveti Georgi-Pernik OOD	Pernik
Bulgaria	Multiprofile Hospital for Active Treatment Heart and Brain, Pleven	Pleven
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	MHAT Sv. Karidad EAD	Plovdiv
Bulgaria	UMHAT 'Sv. Georgi' EAD	Plovdiv
Bulgaria	2th MHAT - Sofia	Sofia
Bulgaria	Diagnostic Consultation Centre 'Alexandrovska' EOOD	Sofia
Bulgaria	National Heart Hospital	Sofia
Bulgaria	UMHAT Prof. Dr. Aleksandar Chirkov	Sofia
Bulgaria	UMHAT Sofia Med	Sofia
Bulgaria	UMHATEM N I Pirogov	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment - Tsaritsa Yoanna - ISUL, EAD	Sofia
Bulgaria	UMHAT Prof. Dr. St. Kirkovich AD	Stara Zagora
Canada	Foothills Hospital	Calgary	Alberta
Canada	Dr. Saul Vizel Cardiac Research Office	Cambridge	Ontario
Canada	University of Alberta	Edmonton	Alberta
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Clinique de Cardiologie de Levis	Levis	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre de Recherche du CHUM	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Halton Healthcare Services Corporation	Oakville	Ontario
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	Centre de Recherche Clinique de Quebec	Quebec
Canada	Institut Universitaire De Cardiologie Et De Pneumologie De Québec	Quebec
Canada	Montreal Heart Institute	Quebec
Canada	CardioVasc HR	St Jean sur Richelieu	Quebec
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur d/b/a CISSS de Lanaudiere	Terrebonne	Quebec
Canada	Toronto Sunnybrook Hospital	Toronto	Ontario
Canada	CIUSSS de la Mauricie-et-du-Centre-du-Quebec	Trois-Rivières	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Office of Dr. Anthony Glanz	Windsor	Ontario
Chile	Quantum Research	Puerto Varas
Chile	Centro de Investigacion Clinica Universidad Catolica de Chile CICUC	Santiago
Chile	Centro de Estudios Cardiologicos y de Medicina Interna	Temuco
Chile	Centro de Investigacion Clinica del Sur	Temuco
Chile	Centro de Estudios Clinicos V Region Ltda	Vina del Mar
China	Baotou Central Hospital	Baotou
China	Beijing Friendship Hospital Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Changzhou No 2 Peoples Hospital	Changzhou
China	Sichuan Provincial Peoples Hospital	Chengdu
China	West China Hospital Sichuan University	Chengdu
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Dongguan People s Hospital	Dongguan
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou
China	GuiZhou Privicial Peoples Hospital	Guiyang
China	The Affiliated Hospital of Guizhou Medical University	Guiyang
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Anhui Province Hospital	Hefei
China	Huizhou Municipal Central Hospital	Huizhou
China	Qilu Hospital of Shandong University	Jinan
China	Shandong Jining No.1 People's Hospital	Jining
China	Lanzhou University Second Hospital	Lanzhou
China	Linfen Central Hospital	Linfen
China	The Second Affiliatde Hospital To Nanchang University	Nanchang
China	Jiangsu Province Hospital	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang
China	Ningbo First Hospital	Ningbo
China	Zhongshan Hospital Fudan University	Shanghai
China	The First Affiliated Hospital of Shantou University Medical	Shantou
China	Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen	Shenzhen
China	The Second Affiliatted Hospital of Soochow University	Su Zhou
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Shanxi Cardiovascular Hospital	Taiyuan
China	The Second Hospital Of Tianjin Medical University	Tianjin
China	Tianjin Chest Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Tianjin People's Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Wenzhou Peoples Hospital	Wenzhou
China	Hubei Zhongshan Hospital The Third Peoples Hospital of Hubei Province	Wuhan
China	The Central Hospital of Wuhan	Wuhan
China	Wuxi People s Hospital	Wuxi
China	The First Affiliated Hospital of Xian Jiaotong University	Xian
China	The Third Affiliated Hospital of Xinxiang Medical University	Xinxiang
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou
China	Yanbian University Hospital	Yanji
China	Yichang Central Pepole's Hospital	Yichang
China	General Hospital of Ningxia Medical Hospital	Yinchuan
China	Affiliated Hospital Of Guangdong Medical University	Zhanjiang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Zhongshan City Peoples Hospital	Zhongshan
China	Affiliated Hospital of Zunyi Medical University	Zunyi
Croatia	General Hospital Dubrovnik	Dubrovnik
Croatia	Special Hospital for medical rehabilitation	Krapinske Toplice
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Croatia	General Hospital Slavonski Brod	Slavonski Brod
Croatia	Poliklinika Solmed	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Vojenska nemocnice Brno	Brno
Czechia	Nemocnice Ceske Budejovice a s	Ceske Budejovice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Kardiocentrum Vysocina CZ a.s.	Jihlava
Czechia	Oblastní nemocnice Kolín	Kolin
Czechia	Krajská nemocnice Liberec a.s.	Liberec
Czechia	Pardubicka krajska nemocnice a s	Pardubice
Czechia	Fakultni nemocnice Plzen	Plzen
Czechia	Ústrední vojenské nemocnice Praha	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Kardiologie Vinohrady s r o	Praha 2
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Institut klinicke a experimentalni mediciny	Praha 4
Czechia	Nemocnice Slany	Slany
Czechia	Nemocnice AGEL - Podlesi a.s.	Trinec
Denmark	Aarhus University Hospital	Aahus N
Denmark	Amager Hospital	Copenhagen S
Denmark	Bispebjerg Og Frederiksberg Hospital	Frederiksberg
Denmark	Herning Regional Hospital	Herning
Denmark	Holbæk Sygehus	Holbæk
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Slagelse Sygehus	Slagelse
Denmark	Odense University Hospital	Svendborg
Denmark	Viborg Hospital	Viborg
France	CHU Angers - Hôpital Hôtel Dieu	Angers
France	CHRU de Tours - Hopital Trousseau	Chambray Les Tours
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes cedex
France	Hopital Henri Mondor	Creteil
France	CHU de Grenoble Hopital Albert Michallon	La Tronche
France	CH de Chartres - Hôpital Louis Pasteur	Le Coudray
France	CHRU de Lille Hopital Claude Huriez	Lille Cedex
France	Centre Hospitalier Saint Joseph Et Saint Luc	Lyon
France	Clinique Du Pont De Chaume	Montauban
France	CHU de Montpellier, Hopital Saint-Eloi	Montpellier
France	Centre Hospitalier Emile Muller	Mulhouse Cedex
France	Centre Hospitalier Universitaire - de Nice - Hopital Pasteur	Nice Cedex 1
France	Hôpital Caremeau	Nîmes Cedex 9
France	Hôpital Bichat - Claude Bernard	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Saint-Antoine	Paris
France	Centre Hospitalier de Pau	Pau Cedex
France	Hôpital du Haut Lévêque	Pessac
France	CHU Poitiers - Hopital la Miletrie	Poitiers
France	Clinique Saint-Hilaire - Centre Frédéric Joliot	Rouen
France	CHU Rouen Hopital Charles Nicolle	Rouen cedex
France	Hopital Rangueil	Toulouse Cedex 9
France	CHU de Nancy - Hopital de Brabois	Vandoeuvre les Nancy Cedex
France	Hopital Andre Mignot	Versailles Cedex
Germany	Klinikum am Plattenwald	Bad Friedrichshall
Germany	Universitaetsklinikum Freiburg	Bad Krozingen
Germany	Kerckhoff-Klinik Bad Nauheim	Bad Nauheim
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Vivantes Humboldt Klinikum	Berlin
Germany	Vivantes Klinikum Im Friedrichshain	Berlin
Germany	Klinikum Bielefeld	Bielefeld
Germany	Marienhausklinikum Eifel Bitburg	Bitburg
Germany	Universitatsklinikum Bonn	Bonn
Germany	GFO Kliniken Bonn, Betriebsstaette St. Marien	Bonn-Beuel
Germany	Staedisches Klinikum Brandenburg	Brandenburg an der Havel
Germany	St. Johannes-Hospital	Dortmund
Germany	Krankenhaus Dresden-Friedrichstadt - Städtisches Klinikum	Dresden
Germany	Katholisches Krankenhaus St. Josef gGmbH - Abtlg. für Gynäkologie	Erfurt
Germany	Universitaetsmedizin Greifswald	Greifswald
Germany	Asklepios Klinik Barmbek	Hamburg
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Klinikum Leverkusen gGmbH	Leverkusen
Germany	Herzzentrum Ludwigshafen	Ludwigshafen
Germany	Klinikum Luedenscheid	Luedenscheid
Germany	Katholisches Klinikum Mainz; Innere Medizin I- Kardiologie	Mainz
Germany	Kliniken Maria Hilf GmbH	Moenchengladbach
Germany	Marienhaus Klinikum	Neuwied
Germany	Sana-Klinikum Remscheid GmbH	Remscheid
Germany	Klinikum Worms gGmbH	Worms
Greece	Uni General Hospital of Alexandroupolis	Alexandroupolis
Greece	General Hospital of Athens 'G. Gennimatas'	Athens
Greece	Hippokration Hospital	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University General Hospital of Ioannina	Ioannina
Greece	University Hospital Of Larissa	Larissa
Greece	General University Hospital of Patras	Patra
Greece	Ahepa University General Hospital of Thessaloniki	Thessaloniki
Greece	Hippokration Hospital	Thessaloniki
Greece	Papageorgiou General Hospital	Thessaloniki
Greece	Papanikolaou General Hospital of Thessaloniki	Thessaloniki
Hungary	Bajcsy-Zsilinszky Kórház és Rendelointézet	Budapest
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Semmelweis Egyetem Varosmajor Sziv es Ergyogyaszati Klinika	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Bacs-kiskun Megyei Korhaz	Kecskemet
Hungary	Szegedi Tudományegyetem Áok Szent-Györgyi Albert Klinikai Központ	Szeged
Hungary	Tolna Megyei Balassa Janos Korhaz	Szekszárd
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Hungary	Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)	Zalaegerszeg
India	Sri Jayadeva Institute	Bangalore
India	KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)	Belgaum
India	Apollo Hospitals	Chennai
India	Lisie Hospital	Cochin
India	Batra Hospital And Medical Research Centre	Delhi
India	Osmania General Hospital	Hyderabad
India	Care Hospitals	Hyderbad
India	IPGMER and SSKM Hospital	Kolkata
India	Rabindranath Tagore International Institute of Cardiac Sciences	Kolkata
India	Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines	Ludhiana
India	Kasturba Medical College Hospital	Mangalore
India	Arneja Heart Institute	Nagpur
India	Central India Cardiology Hospital and Research Institute	Nagpur
India	Crescent Hospital & Heart Center	Nagpur
India	Sir Ganga Ram Hospital	New Delhi
India	KEM Hospital & Research Centre	Pune
India	Ruby Hall Clinic	Pune
India	Nanjappa Hospital	Shimoga
India	Unique Hospital	Surat
Israel	Haemek Medical Center	Afula
Israel	Samson Assuta Ashdod University Hospital	Ashdod
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beersheba
Israel	Bnai Zion Medical Center	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Hadassah University Hospita Ein Kerem	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar-Sava
Israel	Health Corporation of Galilee Medical Center	Naharya
Israel	Rabin Medical Center	Petah Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Assaf Harofeh Medical Center	Rishon Lezion
Israel	Ziv Medical Center	Safed
Israel	Baruch Padeh Medical Center	Tiberias
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria	Alessandria
Italy	Cliniche Humanitas Gavazzeni	Bergamo
Italy	Azienda USL di Bologna - Ospedale Maggiore	Bologna
Italy	Universita D Annunzio	Chieti
Italy	Ospedale Sant'Andrea	La Spezia
Italy	Azienda Ulss 3 Serenissima distretto di Mirano	Mestre
Italy	Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)	Milano
Italy	Centro Cardiologico Monzino	Milano
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	A. O.U. Pisana Ospedale di Cisanello	Pisa
Italy	Fondazione Policlinico Universitario A Gemelli IRCCS	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Ospedale San Francesco	Sassari
Italy	Ospedale Bolognini	Seriate
Italy	IRCCS Multimedica di Sesto San Giovanni	Sesto San Giovanni
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Torrette Di Ancona
Italy	Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio	Treviglio
Japan	Kasugai Municipal Hospital	Aichi
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki shi
Japan	Chiba University Hospital	Chiba
Japan	Funabashi Munitiple Medical Center	Chiba
Japan	Saiseikai Futsukaichi Hospital	Chikushino-shi
Japan	Fukui Prefectural Hospital	Fukui-shi
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Fukuoka Wajiro Hospital	Fukuoka-shi
Japan	Kyushu University Hospital	Fukuoka-shi
Japan	Gifu Prefectural General Medical Center	Gifu
Japan	National Hospital Organization Takasaki General Medical Center	Gunma
Japan	Hyogo Prefectural Harima-Himeji General Medical Center	Himeji-shi
Japan	Hiratsuka Kyosai Hospital	Hiratsuka-shi
Japan	Hirosaki University Hospital	Hirosaki
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Tokai University Hospital	Isehara
Japan	Public Central Hospital of Matto Ishikawa	Ishikawa
Japan	Teikyo University Hospital	Itabashi Ku
Japan	Juntendo University Shizuoka Hospital	Izunokuni-shi
Japan	Tesshokai Kameeda Clinic	Kamogawa
Japan	Showa University Fujigaoka Hospital	Kanagawa
Japan	Asanokawa, Kanazawa Cardiovascular Hospital	Kanazawa-shi
Japan	Fukuoka Tokushukai Hospital	Kasuga-shi
Japan	Kimitsu Chuo Hospital	Kisarazu-shi
Japan	Kokura Memorial Hospital	Kitakyushu-shi
Japan	Chikamori Hospital	Kochi
Japan	National Hospital Organization Fukuoka Higashi Medical Center	Koga
Japan	Saiseikai Kumamoto Hospital	Kumamoto-shi
Japan	Kurashiki Central Hospital	Kurashiki
Japan	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Kure-shi
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Kyoto University Hospital	Kyoto-shi
Japan	Chiba-Nishi General Hospital	Matsudo-shi
Japan	Jisenkai Aizawa Hospital	Matsumoto-shi
Japan	Toho University Medical Center, Ohashi Hospital	Meguro-ku
Japan	Tokyo Saiseikai Central Hospital	Minato-ku
Japan	Miyazaki Medical Association Hospital	Miyazaki-shi
Japan	Japanese Red Cross Nagoya Daiichi Hospital	Nagoya-shi
Japan	NHO Nagoya Medical Center	Nagoya-shi
Japan	Hyogo Medical University Hospital	Nishinomiya-shi
Japan	Okayama Rosai Hospital	Okayama shi
Japan	Osaka City General Hospital	Osaka
Japan	Osaka Police Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka-shi
Japan	Saga University Hospital	Saga
Japan	Kitasato University Hospital	Sagamihara
Japan	National Hospital Organization Saitama National Hospital	Saitama
Japan	Kosekai Iwatsuki-minami Hospital	Saitama-shi
Japan	Tohoku University Hospital	Sendai
Japan	Showa University Hospital	Shinagawa
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku
Japan	Iwate Medical University Hospital	Shiwa-gun
Japan	National Cerebral and Cardiovascular Center	Suita-Shi
Japan	Kagawa Prefectural Central Hospital	Takamatsu
Japan	Tokushima University Hospital	Tokushima
Japan	Mitsui Memorial Hospital	Tokyo
Japan	National Hospital Organization Tokyo Medical Center	Tokyo
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	Ome Medical Center	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama-shi
Japan	Mie University Hospital	Tsu
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura-City
Japan	Tsukuba Medical Center Hospital	Tsukuba shi
Japan	Yamaguchi University Hospital	Ube
Japan	Tokyobay Urayasu Ichikawa Medical Center	Urayasu-shi
Japan	National Hospital Organization Ureshino Medical Center	Ureshino-shi
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Yokohama City University Medical Center	Yokohama
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Ewha Womans University Mokdong Hospital	Gangseo-gu
Korea, Republic of	Myongji Hospital	Goyang-si
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	WonJu Severance Christian Hospital	Wonju
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan Si
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Klaipeda Seamen's Hospital, Public Institution	Klaipeda
Lithuania	Vilnius University Hospital Santariskiu Clinic, Public Institution	Vilnius
Malaysia	Hospital Raja Perempuan Zainab Ii	Kota Bahru
Malaysia	Hospital University Sains Malaysia	Kota Bharu
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Hospital Miri	Miri
Malaysia	Hospital Seberang Jaya	Seberang Jaya
Malaysia	Universiti Teknologi Mara	Selayang
Mexico	Centro de Investigacion Cardiovascular y Metabolica	Tijuana
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Treant Zorggroep	Emmen
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Admiraal De Ruyter Ziekenhuis - Goes	Goes
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Ziekenhuis St Jansdal	Harderwijk
Netherlands	Zuyderland Medical Center	Heerlen
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Alrijne Ziekenhuis Leiden ; Cardiology	Leiderdorp
Netherlands	Maastricht UMC	Maastricht
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Radboudumc	Nijmegen
Netherlands	Bravis	Roosendaal
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Netherlands	Jeroen Bosch Ziekenhuis	s-Hertogenbosch
Netherlands	D & A Research	Sneek
Netherlands	Ziekenhuis Rivierenland	Tiel
Netherlands	Diakonessenhuis	Utrecht
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	VieCuri Medisch Centrum	Venlo
Netherlands	Gelre Ziekenhuizen Zutphen	Zutphen
New Zealand	Auckland City Hospital	Auckland
New Zealand	North Shore Hospital	Auckland
New Zealand	University of Otago	Christchurch
New Zealand	Dunedin Public Hospital	Dunedin
New Zealand	Hawkes Bay Hospital	Hastings
New Zealand	Taranaki Base Hospital	New Plymouth
New Zealand	Middlemore Hospital	Otahuhu
New Zealand	Rotorua Hospital	Rotorua
New Zealand	Tauranga Hospital	Tauranga
New Zealand	Whangarei Hospital	Whangarei
Poland	NZOZ Centrum Medyczne KERmed	Bydgoszcz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Bytom
Poland	Wojewódzki Szpital Zespolony w Elblagu	Elblag
Poland	Clinical Medical Research Sp. z o.o.	Katowice
Poland	Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego	Kielce
Poland	Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska	Krakow
Poland	Krakowski Szpital Specjalistyczny im Jana Pawla II	Krakow
Poland	Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii	Krakow
Poland	1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie	Lublin
Poland	NZOZ Osrodek Kardiologii Inwazyjnej -Ikardia	Naleczow
Poland	FutureMeds Olsztyn	Olsztyn
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Medicome Sp. Z O.O.	Oswiecim
Poland	Wojewodzki Szpital im Sw Ojcia Pio w Przemyslu	Przemysl
Poland	Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II	Siedlce
Poland	ETG Skierniewice	Skierniewice
Poland	NZOZ PRO CORDIS Sopockie Centrum Badan Kardiologicznych	Sopot
Poland	Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu	Torun
Poland	Specjalistyczny Szpital im. dra Alfreda Sokolowskiego w Walbrzychu	Walbrzych
Poland	Instytut Kardiologii im Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warszawa
Poland	4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ	Wroclaw
Poland	Wojewodzki Szpital Specjalistyczny we Wroclawiu	Wroclaw
Portugal	Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro	Aveiro
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar Cova da Beira, EPE - Hospital Pêro da Covilhã	Covilha
Portugal	Hosp. Sra. Da Oliveira - Guimaraes	Guimaraes
Portugal	Centro Hospitalar de Leiria	Leiria
Portugal	Centro Hospitalar de Lisboa Norte Hospital Santa Maria	Lisboa
Portugal	Centro Hospitalar de Lisboa Central	Lisbon
Portugal	Centro Hospitalar de Entre o Douro e Vouga, E.P.E	Santa Maria da Feira
Portugal	Centro Hospitalar de Vila Nova de Gaia Espinho E P E	Vila Nova de Gaia
Portugal	Centro Hospitalar de Trás os Montes e Alto Douro- Vila Real	Vila Real
Romania	Spitalul Judetean de Urgenta Dr. Constantin Opris	Baia-Mare
Romania	Spitalul Clinic Judetean de Urgenta Brasov	Brasov
Romania	Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu	Bucharest
Romania	Spitalul Clinic de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'	Bucuresti
Romania	Spitalul Angiocare SRL	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Cluj Napoca	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei	Constanta
Romania	Spitalul Clinic Judetean de Urgenta Craiova	Craiova
Romania	Institutul de Boli Cardiovasculare Iasi	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Oradea	Oradea
Romania	SAL MED Pitesti	Pitesti
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu-Mures
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Tg. Mures
Romania	Clinica Medicaliss	Timisoara
Romania	Institutul de Boli Cardiovasculare Timisoara	Timisoara
Romania	Spitalul Clinic Municipal de Urgenta Timisoara	Timisoara
Serbia	Clinical Center Dr Dragisa Misovic Dedinje	Belgrade
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	University Clinical Hospital Center Dr Dragisa Misovic- Dedi	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	Nis
Serbia	Institute for Treatment and Rehabilitation Niska Banja	Niska Banja
Serbia	General Hospital Pancevo	Pancevo
Serbia	General Hospital Smederevo	Smederevo
Serbia	General Hospital Sremska Mitrovica	Sremska Mitrovica
Serbia	Health Center Zajecar	Zajecar
Slovakia	Stredoslovensky ustav srdcovych a cievnych chorob a.s	Banska Bystrica
Slovakia	Alian s.r.o.	Bardejov
Slovakia	Premedix Clinic	Bratislava
Slovakia	Nemocnica s poliklinikou Brezno	Brezno
Slovakia	Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.	Košice
Slovakia	Interno Kardio s r o	Kosice
Slovakia	Kardiologicka ambulancia CARDIO D&R s.r.o.	Kosice
Slovakia	Kardio 1 S.R.O.	Lucenec
Slovakia	Univerzitná nemocnica Martin	Martin
Slovakia	Kardiologicka ambulancia MEDI M&M s.r.o.	Moldava nad Bodvou
Slovakia	Kardiocentrum Nitra s.r.o.	Nitra
Slovakia	Cardioinvest s.r.o.	Nove Zamky
Slovakia	Interna SK s.r.o.	Svidnik
Slovakia	MEDIVASA s.r.o.	Zilina
Slovakia	Nemocnica AGEL Zvolen a s	Zvolen
South Africa	Panorama MediClinic	Cape Town
South Africa	Tiervlei Trial Centre	Cape Town
South Africa	Tread Research	Cape Town
South Africa	Johese Clinical Research	Centurion
South Africa	Durban Medical Centre	Durban
South Africa	Garda, RA	Johannesburg
South Africa	Dr J.M. Engelbrecht Trial Site	Somerset West
South Africa	Helderberg Research Institute	Somerset West
South Africa	Clinical Projects Research SA (PTY) LTD	Worcester
Spain	Hosp. Gral. Univ. de Alicante	Alicante
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. Virgen de La Arrixaca	El Palmar
Spain	Hosp. Univ. Arnau de Vilanova de Lleida	Lleida
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. Hm Monteprincipe	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. Virgen de La Luz	Madrid
Spain	Hosp. Virgen de La Victoria	Malaga
Spain	Hosp. de Manises	Manises
Spain	Complejo Hosp. de Navarra	Pamplona
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Univ. Joan Xxiii	Tarragona
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Spain	Hosp. Gral. Univ. Valencia	Valencia
Spain	Hosp. Alvaro Cunqueiro	Vigo
Spain	Hosp. Univ. Miguel Servet	Zaragoza
Switzerland	Universitatsspital Basel	Basel
Switzerland	Universitätspital Bern, Universitätsklinik für Frauenheilkunde	Bern
Switzerland	Hopitaux Universitaires de Geneve - HUG	Geneve 14
Switzerland	Istituto Cardiocentro Ticino	Lugano
Switzerland	UniversitaetsSpital Zuerich	Zuerich
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	E-DA Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei
Taiwan	Mackay Memorial Hospital	New Taipei
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chi Mei Medical Center Yong Kang	Tainan
Taiwan	Cathay General Hospital	Taipei
Taiwan	Cheng Hsin General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University	Taipei City
Taiwan	Chang Gung Memorial Hospital- Linkou	Taoyuan County
Taiwan	National Yang-Ming University Hospital	Yilan County
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkoknoi
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiangmai
Thailand	Srinagarind Hospital	Nai Mueang Subdistrict Mueang
Thailand	King Chulalongkorn Memorial Hospital	Pathum Wan
Turkey	Afyon Kocatepe University Medical Faculty	Afyon
Turkey	Ankara Numune Research and Training Hospital	Ankara
Turkey	Osmangazi University Medical Faculty	Eskisehir
Turkey	Bezmi Alem Vakif University Medical Faculty Hospital	Istanbul
Turkey	Dokuz Eylul University Medical Faculty	Izmir
Turkey	Karabuk University Medical Faculty	Karabuk
Turkey	Erciyes University Medical Faculty	Kayseri
Turkey	Kutahya Health Science University Evliya Celebi Research and Training Hospital	Kutahya
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Ondokuz Mayis University	Samsun
United Kingdom	Basingstoke And North Hampshire Hospital	Basingstoke
United Kingdom	Royal United Hospital	Bath
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	University Hospital Bristol and Weston NHS trust	Bristol
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Russels Hall Hospital	Dudley
United Kingdom	Hairmyres Hospital	East Kilbride
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital(Wonford)	Exeter
United Kingdom	Royal Free Hospital	Hampstead
United Kingdom	Harefield Hospital	Harefield
United Kingdom	West Middlesex University Hospital	Isleworth
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Lincoln County Hospital	Lincoln
United Kingdom	Barts Hospital	London
United Kingdom	Hammersmith Hospital	London
United Kingdom	Altnagelvin Hospital	Londonderry
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Peterborough City Hospital	Peterborough
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Musgrove Park Hospital	Taunton
United Kingdom	Torbay Hospital-Devon	Torquay
United Kingdom	Sandwell and West Birmingham Hospitals NHS Trust-Sandwell Gene	West Bromwich
United Kingdom	Royal Albert Edward Infirmary	Wigan
United Kingdom	Yeovil District Hospital	Yeovil
United States	Summa Health System	Akron	Ohio
United States	Advanced Cardiovascular, LLC	Alexander City	Alabama
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Amarillo Heart Clinical Research Institute	Amarillo	Texas
United States	PharmaTex Research	Amarillo	Texas
United States	AnMed Health	Anderson	South Carolina
United States	University of Michigan	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Bakersfield Memorial Hospital	Bakersfield	California
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Eastern Maine Medical Center Northeast Cardiology Associates	Bangor	Maine
United States	Ascension Medical Group - St. John Clinic Infectious Disease	Bartlesville	Oklahoma
United States	Suburban Hospital	Bethesda	Maryland
United States	Ascension St. Vincent's Health System	Birmingham	Alabama
United States	SORRA Research	Birmingham	Alabama
United States	FWD Clinical Research	Boca Raton	Florida
United States	Cardiac Care & Vascular Medicine, PLLC	Bronx	New York
United States	Buffalo General Medical Center	Buffalo	New York
United States	Atlanta Clinical Research Center	Cartersville	Georgia
United States	Clinical Trials of America	Cary	North Carolina
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	UNC School of Medicine	Chapel Hill	North Carolina
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Kootenai Medical Center	Coeur d'Alene	Idaho
United States	The Curators of the University of Missouri on behalf of University of Missouri Health Care	Columbia	Missouri
United States	Nuvance Health Medical Practices Cardiology Danbury	Danbury	Connecticut
United States	St. Luke's Cardiology Associates	Duluth	Minnesota
United States	Med Research, Inc.	El Paso	Texas
United States	Texas Tech University Health Sciences Center-El Paso	El Paso	Texas
United States	Midwest Cardiovascular Research Foundation	Elkhart	Indiana
United States	Englewood Health	Englewood	New Jersey
United States	Hamot Medical Center	Erie	Pennsylvania
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Virginia Heart	Falls Church	Virginia
United States	AAMRC	Flint	Michigan
United States	Holy Cross Hospital Inc.	Fort Lauderdale	Florida
United States	Integrative Research Associates	Fort Lauderdale	Florida
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	The Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	St. Francis Physician Services, Inc, DBA Upstate Cardiology Research	Greenville	South Carolina
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	UPMC Pinnacle Health	Harrisburg	Pennsylvania
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Inpatient Research Clinic LLC	Hialeah	Florida
United States	East Texas Cardiology, PA	Houston	Texas
United States	Physician Research Network	Houston	Texas
United States	Apex Cardiology	Jackson	Tennessee
United States	Shands Jacksonville Medical Center Inc dba UF Health Jacksonville	Jacksonville	Florida
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Spectrum Clinical Research	Kansas City	Missouri
United States	Kettering Medical Center	Kettering	Ohio
United States	Texas Cardiology Research Center	Kingwood	Texas
United States	Ascension Texas Cardiovascular	Kyle	Texas
United States	Mayo Clinic Health System	La Crosse	Wisconsin
United States	Captiol Cardiology Associates	Lanham	Maryland
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Clinical Trials of America	Lenoir	North Carolina
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Norton Cardiovascular Associates	Louisville	Kentucky
United States	Cardiology Partners Clinical Research Institute	Loxahatchee Groves	Florida
United States	Baptist Hospital of Miami	Miami	Florida
United States	Trinity Medical Group	Minot	North Dakota
United States	Cardiology Associates of Mobile Inc	Mobile	Alabama
United States	IMC-Diagnostic and Medical Clinic	Mobile	Alabama
United States	IU Health Ball Memorial Hospital	Muncie	Indiana
United States	Advanced Research for Health Improvement	Naples	Florida
United States	Ascension Saint Thomas West Hospital	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Clinic And Hospital	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Weil Cornell University	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Radin Cardiovascular Medical Group	Newport Beach	California
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Amavita Clinical Research (Dr. Pedro Martinez-Clark)	North Miami Beach	Florida
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Parkway Cardiology Associates PC	Oak Ridge	Tennessee
United States	South Oklahoma Heart Research	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinic Heart Consultants	Omaha	Nebraska
United States	Stanford University School of Medicine	Palo Alto	California
United States	South Florida Research Solutions LLC	Pembroke Pines	Florida
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	OSF HealthCare Cardiovascular Institute	Peoria	Illinois
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	Atlanticare Regional Medical Center	Pomona	New Jersey
United States	Hudson Valley Cardiovascular Practice, PC	Poughkeepsie	New York
United States	Rex Hospital	Raleigh	North Carolina
United States	Monument Health Clinical Research	Rapid City	South Dakota
United States	The Cardiovascular Center	Redding	California
United States	Reid Health	Richmond	Indiana
United States	Carolina Cardiology Associates	Rock Hill	South Carolina
United States	Tidal Health Peninsula Regional Inc.	Salisbury	Maryland
United States	San Diego Cardiac Center	San Diego	California
United States	University Of California San Diego	San Diego	California
United States	VA San Diego Health Care System	San Diego	California
United States	Sanford Cardiology	Sanford	North Carolina
United States	UCLA	Santa Monica	California
United States	Northbay Cancer Center	Santa Rosa	California
United States	Cardiovascular Center of Sarasota	Sarasota	Florida
United States	HonorHealth Neurology	Scottsdale	Arizona
United States	Cardiovoyage	Sherman	Texas
United States	Louisiana Heart Center	Slidell	Louisiana
United States	Cardio Metabolic Institute	Somerset	New Jersey
United States	Cox Health	Springfield	Missouri
United States	Prairie Cardiovascular Consultants, Ltd.	Springfield	Illinois
United States	The Heart House	Springfield	Ohio
United States	Cardiology Associates of Fairfield County, P.C.	Stamford	Connecticut
United States	Ramin Manshadi, MD	Stockton	California
United States	MultiCare Health System	Tacoma	Washington
United States	Tampa Cardiovascular Interventions and Research	Tampa	Florida
United States	South Georgia Urology Group Pc	Thomasville	Georgia
United States	Northwest Heart Clinical Research, LLC.	Tomball	Texas
United States	Interventional Cardiac Consultants	Trinity	Florida
United States	St John Health System Inc	Tulsa	Oklahoma
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Cardiology Partners Clinical Research Institute	Wellington	Florida
United States	Monroe Research LLC	West Monroe	Louisiana
United States	Winchester Medical Center	Winchester	Virginia
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)	Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.	Up to 3 years 6 months
Secondary	Time to the First Occurrence of Major Adverse Vascular Event (MAVE)	Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).	Up to 3 years 6 months
Secondary	Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke	Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.	Up to 3 years 6 months
Secondary	Time to Cardiovascular (CV) Death	Time to CV death will be reported.	Up to 3 years 6 months
Secondary	Time to All-cause Mortality (ACM)	Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.	Up to 3 years 6 months