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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509674
Other study ID # 1245-0202
Secondary ID 2019-001037-13
Status Completed
Phase Phase 3
First received
Last updated
Start date December 16, 2020
Est. completion date November 5, 2023

Study information

Verified date November 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.


Recruitment information / eligibility

Status Completed
Enrollment 6522
Est. completion date November 5, 2023
Est. primary completion date November 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Of full age of consent (according to local legislation, at least = 18 years) at screening. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. 4. Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission. 5. High risk of HF, defined as EITHER 1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization. OR 2. Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation. 6. In addition at least one of the following risk factors: - Age > 65 years, - Newly developed LVEF < 35%, - Prior MI (before index MI) documented in medical records, - Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation), - Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI), - Type 2 diabetes mellitus (prior or new diagnosis), - N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation, - Uric acid >7.5 mg/dL (>446 µmol/L), measured at any time during hospitalisation, - Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation), - Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries), - 3-vessel coronary artery disease at time of index MI, - Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease). Exclusion Criteria: 1. Diagnosis of chronic Heart Failure (HF) prior to index MI. 2. Systolic blood pressure < 90 mmHg at randomisation. 3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation. 4. Coronary Artery Bypass Grafting planned at time of randomisation. 5. Current diagnosis of Takotsubo cardiomyopathy. 6. Any current severe (stenotic or regurgitant) valvular heart disease. 7. eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis. 8. Type I diabetes mellitus. Further exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Empagliflozin
Empagliflozin
Placebo
Placebo

Locations

Country Name City State
Argentina Instituto Cardiovascular de Buenos Aires Belgrano
Argentina Fundacion Sanatorio Güemes Ciudad Autonoma Buenos Aires
Argentina Centro Medico Luquez Cordoba
Argentina Clinica Privada del Prado Cordoba
Argentina Hospital Italiano de Córdoba Cordoba
Argentina Hospital Privado Centro Medico de Cordoba Cordoba
Argentina Sanatorio Allende Cordoba
Argentina Centro de Investigacion Clinica Coronel Suarez Coronel Suarez
Argentina Instituto de Cardiología de Corrientes Corrientes
Argentina Fundación Favaloro para la Docencia e Investigación Medica Monserrat
Argentina Sanatorio Modelo de Quilmes Quilmes
Argentina Instituto Cardiovascular de Rosario Rosario
Argentina Sanatorio Delta Rosario
Argentina Sanatorio Parque Rosario
Argentina Corporacion Medica de Gral. San Martin S.A. San Martin
Argentina Centro Privado de Cardiología San Miguel de Tucuman
Argentina Clinica U.O.M. San Nicolas
Argentina Sanatorio Diagnóstico Santa Fe
Argentina Hospital "Dr. José Maria Cullen" Santa Fé
Argentina Clinica Privada Fusavim SRL Villa Maria
Australia The Prince Charles Hospital Chermside Queensland
Australia Concord Repatriation General Hospital Concord New South Wales
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia South Western Sydney Local Health District Liverpool New South Wales
Australia Alfred Hospital Melbourne Victoria
Australia Gold Coast University Hospital Southport Queensland
Australia Royal North Shore Hospital St Leonards New South Wales
Australia Westmead Hospital Westmead New South Wales
Brazil JMF Clinica Do Coracao LTDA Aracaju - SE
Brazil Hospital Santa Isabel Balneario Camboriu
Brazil Hospital Madre Teresa Belo Horizonte
Brazil Hospital do Coracao do Brasil Brasilia
Brazil Hospital Angelina Caron Campina Grande do Sul
Brazil Centro Especializado em Cardiol Loema Instituto de Pesq Clin Campinas
Brazil IPECC - Instituto de Pesquisa Clínica de Campinas Campinas
Brazil Hospital de Messejana Dr. Carlos Alberto Studart Gomes Fortaleza
Brazil HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiania
Brazil Hospital Regional Hans Dieter Schmidt Joinville
Brazil Santa Casa de Misericórdia de Marília Marília
Brazil Hospital São Vicente de Paulo Passo Fundo
Brazil Hospital Nossa Senhora da Conceição Porto Alegre
Brazil Hospital Sao Lucas da PUCRS Porto Alegre
Brazil Instituto de Cardiologia Rio Grande do Sul Porto Alegre
Brazil Hospital Agamenon Magalhaes Recife
Brazil Fundacao de apoio ao ensino e assitencia HCFMRP Ribeirao Preto
Brazil Hospital Copa D'or Rio de Janeiro
Brazil Instituto de Ensino E Pesquisa Do Hospital Da Bahia Salvador
Brazil CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo
Brazil Hospital de Base - Fac Med de Sao Jose do Rio Preto Sao Jose do Rio Preto
Brazil Hospital das Clínicas de Sao Paulo - INCOR Sao Paulo
Brazil Hospital Samaritano Sao Paulo
Brazil Hospital Sao Luiz Jabaquara Sao Paulo
Brazil Hospital Sao Luiz Morumbi Sao Paulo
Brazil Santa Casa de Votuporanga Votuporanga
Bulgaria Multiprofile Hospital For Active Treatment Pulse AD Blagoevgrad
Bulgaria Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD Gabrovo
Bulgaria Multiprofile Hospital for Active Treatment AD Haskovo Haskovo
Bulgaria Multiprofile Hospital For Active Treatment - Pazardzhik AD Pazardzhik
Bulgaria Specialized Hospital for Active Treatment Sv. Georgi - Pernik Pernik
Bulgaria Medical Center Medconsult Pleven LTD Pleven
Bulgaria Multiprofile Hospital for Active Treatment Heart and Brain EAD Pleven
Bulgaria SHAT in Cardiology EAD, Pleven Pleven
Bulgaria Hospital MHAT Plovdiv, AD Plovdiv
Bulgaria City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia Sofia
Bulgaria Medical Military Academy MHAT Sofia Sofia
Bulgaria MHAT Sv.Anna, Clinic of Internal Diseases, Sofia Sofia
Bulgaria Multiprofile Hospital MHATEM 'Pirogov', Sofia Sofia
Bulgaria National Heart Hospital, Sofia Sofia
Bulgaria UMHAT "Tsaritsa Yoannalsul" Sofia
Bulgaria University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD Sofia
Bulgaria Hospital Trakia Park Stara Zagora
Canada William Osler Health Centre Brampton Ontario
Canada Heritage Medical Research Clinic Calgary Alberta
Canada Royal Alexandra Hospital Edmonton Alberta
Canada University of Alberta Hospital (University of Alberta) Edmonton Alberta
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Royal Inland Hospital Kamloops British Columbia
Canada Queen's University Kingston Ontario
Canada One Heart Care Ventures Mississauga Ontario
Canada GA Research Associates Ltd. Moncton New Brunswick
Canada Centre Hospitalier de l'Universite de Montreal (CHUM) Montreal Quebec
Canada McGill University Health Centre (MUHC) Montreal Quebec
Canada Montreal General Hospital - McGill University Health Centre Montreal Quebec
Canada Montreal Heart Institute Montreal Quebec
Canada Southlake Regional Health Centre Newmarket Ontario
Canada Oakville Trafalgar Memorial Hospital Oakville
Canada Peterborough Regional Health Centre Peterborough Ontario
Canada Prairie Vascular Research Inc. Regina Saskatchewan
Canada IUCPQ (Laval University) Sainte-Foy Quebec
Canada Heart Health Institute Scarborough Ontario
Canada CIUSSS de l Estrie-CHUS Sherbrooke Quebec
Canada Surrey Memorial Hospital Surrey British Columbia
Canada CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur Terrebonne (Lachenaie) Quebec
Canada Women's College Hospital Toronto Ontario
Canada CIUSSS de la Mauricie-et-du-Centre-du-Quebec Trois-Rivieres Quebec
Canada Vancouver General Hospital Vancouver British Columbia
Canada Victoria Heart Institute Foundation Victoria British Columbia
Canada St. Boniface Hospital Winnipeg Manitoba
China Beijing Chao-Yang Hospital Beijing
China Beijing Luhe Hospital Capital Medical University Beijing
China China-Japan Friendship Hospital Beijing
China Chinese PLA General Hospital Beijing
China Peking University First Hospital Beijing
China Changsha Central Hospital Changsha
China Xiangya Hospital, Central South University Changsha
China Guangdong Provincial People's Hospital Guangzhou
China The First Affiliated Hospital of Harbin Medical University Haerbin
China Hainan General Hospital Haikou
China Shulan(Hanghzhou) Hospital Hangzhou
China Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou
China Zhejiang Hospital Hangzhou
China The Second Affiliated Hospital of Lanzhou Medical University Lanzhou
China Nanjing Drum Tower Hospital Nanjing
China Zhongshan Hospital Fudan University Shanghai
China People's Hospital of Liaoning Province Shenyang
China Peking University Shenzhen Hospital Shenzhen
China Renmin Hospital of Wuhan University Wuhan
Denmark Aalborg Universitetsshospital Aalborg
Denmark Aarhus University Hospital Aarhus N
Denmark Rigshospitalet Copenhagen
Denmark Frederiksberg Hospital Frederiksberg
Denmark Herlev and Gentofte Hospital Herlev
Denmark Slagelse Sygehus Slagelse
France HOP Sud Francilien Corbeil Essonnes
France HOP CHU de Grenoble Grenoble Cedex 9
France CHRU Lille Lille
France Hospital de Saint Joseph et Saint Luc Lyon
France HOP Bichat Paris
France CHU Rouen Rouen Cedex
France HOP Trousseau Tours
France HOP Brabois Vandoeuvre-lès-Nancy
Germany SLK-Kliniken Heilbronn GmbH Bad Friedrichshall
Germany Kerckhoff-Klinik, Bad Nauheim Bad Nauheim
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Bonn AöR Bonn
Germany Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser Bremen
Germany Klinikum Coburg gGmbH Coburg
Germany St. Johannes Hospital Dortmund Dortmund
Germany Städtisches Klinikum Dresden Dresden
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany Klinikum Frankfurt Höchst GmbH Frankfurt/Main
Germany Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH Freiburg I. Breisgau
Germany Asklepios Kliniken GmbH & Co. KGaA Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Ambulantes Herzzentrum Kassel Kassel
Germany Universitätsklinikum Leipzig Leipzig
Germany Katholisches Klinikum Mainz Mainz
Germany Clemenshospital Münster
Germany Kardiologische Praxis Papenburg Papenburg
Germany Universitätsklinikum Regensburg Regensburg
Hungary Lausmed Kft. Outpatient Unit of Internal Medicine Baja
Hungary Buda Hospital of the Hospitaller Order of Saint John of God Budapest
Hungary Jahn Ferenc Del-Pest Hospital Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Semmelweis University Budapest
Hungary Semmelweis University Budapest
Hungary St. Imre Hospital, Budapest Budapest
Hungary University Debrecen Hospital Debrecen
Hungary Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako Hodmezovasarhely
Hungary Somogy County Kaposi Mor Teaching Hospital Kaposvar
Hungary Bacs-Kiskun Megyei Onkormanyzat Hospital Kecskemet
Hungary Pest Megyei Flor Ferenc Hospital Kistarcsa
Hungary University of Szeged Szeged
Hungary Fejer County Saint George University Teaching Hospital Szekesfehervar
Hungary Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet Szolnok
Hungary Zala County Hospital, Zalaegerszeg Zalaegerszeg
India Kamalnayan Bajaj Hospital Aurangabad
India Narayana Institute of Cardiac Sciences Bangalore
India Sri Jayadeva Institute of Cardiovascular Sciences & Research Bangalore
India KLES Dr.Prabhakar Kore Hospital and Medical Research Centre Belagavi
India Madras Medical Mission, Chennai
India Eternal Heart Care Centre & Research Institute Pvt. Ltd. Jaipur
India KEM Hospital and Seth G S Medical College Mumbai
India Sion Hospital (Lokmanya Tilak Municipal Hospital) Mumbai
India Government Medical College & Hospital Nagpur
India GB Pant Institute of Post Graduate Medical Education and Research New Delhi
India Max Superspeciality Hospital New Delhi
India Sir Gangaram Hospital New Delhi
India Sahyadri Speciality Hospital Pune
Israel Haemek Medical Center Afula
Israel Assuta Medical Center Ashdod
Israel Barzilai Medical Center Ashkelon
Israel Soroka Univ. Medical Center Beer Sheba
Israel Assaf Harofe Medical Center Beer Yaacov
Israel Hillel Yaffe Medical Center, Hadera Hadera
Israel Bnei Zion Medical Center, Haifa Haifa
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Hadassah Medical Center, Ein-Karem Jerusalem
Israel Hadassah Medical Center, Ein-Karem Jerusalem
Israel Shaare Zedek Medical Center, Jerusalem 91031 Jerusalem
Israel Meir Medical Center Kfar-Saba
Israel West.Galilee Med.Cent.Naharia Nahariya
Israel Rabin Medical Center Beilinson Petah Tikva
Israel Rabin Medical Center Beilinson Petah Tikva
Israel The Chaim Sheba Medical Center Tel HaShomer Ramat Gan
Israel Kaplan Medical Center Rehovot
Israel Ziv Medical Center Safed
Israel Sourasky Medical Center Tel Aviv
Israel Baruch Padeh Medical Center Tiberias
Japan Kasugai Municipal Hospital Aichi, Kasugai
Japan Toyota Memorial Hospital Aichi, Toyota
Japan Chibanishi General Hospital Chiba, Matsudo
Japan Seikeikai New Tokyo Heart Clinic Chiba, Matsudo
Japan Saiseikai Fukuoka General Hospital Fukuoka, Fukuoka
Japan Gifu Prefectural General Medical Center Gifu, Gifu
Japan Ogaki Municipal Hospital Gifu, Ogaki
Japan Hiroshima General Hospital Hatsukaichi
Japan Hiroshima Prefectural Hospital Hiroshima, Hiroshima
Japan Hyogo Brain and Heart Center Hyogo, Himeji
Japan Ibaraki Prefectural Central Hospital Ibaraki, Kasama
Japan Tsuchiura Kyodo General Hospital Ibaraki, Tsuchiura
Japan Ishikawa Prefectural Central Hospital Ishikawa, Kanazawa
Japan Juntendo University Shizuoka Hospital Izunokuni
Japan Tokai University Hospital Kanagawa, Isehara
Japan Sagamihara Kyodo Hospital Kanagawa, Sagamihara
Japan Yokohama City University Medical Center Kanagawa, Yokohama
Japan Fukuoka Tokushukai Hospital Kasuga
Japan Japanese Red Cross Kumamoto Hospital Kumamoto, Kumamoto
Japan Saiseikai Kumamoto Hospital Kumamoto, Kumamoto
Japan Kusatsu General Hospital Kusatsu
Japan Miyazaki Medical Association Hospital Miyazaki
Japan Nagano Chuo Hospital Nagano, Nagano
Japan Osaka Police Hospital Osaka, Osaka
Japan Kagawa Prefectural Central Hospital Takamatsu
Japan Tokushima Prefectural Central Hospital Tokushima
Japan St. Luke's International Hospital Tokyo, Chuo-ku
Japan Tokyo Bay Urayasu Ichikawa Medical Center Urayasu
Japan Showa University Fujigaoka Hospital Yokohama
Korea, Republic of Bucheon Sejong Hospital Bucheon
Korea, Republic of Pusan National Univ. Hosp Busan
Korea, Republic of Chungbuk National University Hospital Cheongiu
Korea, Republic of Chungnam National University Hospital Daejoen
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-si
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Amsterdam UMC Locatie VUMC Amsterdam
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Rijnstate Hospital Arnhem
Netherlands Amphia Ziekenhuis Breda
Netherlands IJsselland Ziekenhuis Capelle Aan Den Ijssel
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Medisch Spectrum Twente Enschede
Netherlands Admiraal de Ruyter Ziekenhuis Goes
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Spaarne Ziekenhuis Haarlem
Netherlands Zuyderland Medisch Centrum Heerlen
Netherlands Jeroen Bosch Ziekenhuis-Hertogenbosch Hertogenbosch
Netherlands Tergooi Ziekenhuis Hilversum
Netherlands Vasculair Onderzoek Centrum Hoorn
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands Alrijne Ziekenhuis Leiden
Netherlands Leids Universitair Medisch Centrum (LUMC) Leiden
Netherlands Ziekenhuis Rivierenland Tiel
Netherlands Tweesteden Ziekenhuis, locatie Tilburg Tilburg
Netherlands Isala Zwolle Zwolle
Poland American Heart of Poland Belchatow
Poland Univ. Clinic Hosp, Bialystok Bialystok
Poland American Heart of Poland Sp. z o.o. Bielsko-Biala
Poland American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre Chorzow
Poland American Heart of Poland Sp. z o.o. Dabrowa Gornicza
Poland NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog. Gdynia
Poland Silesian Medical University in Katowice Katowice
Poland American Heart of Poland Sp. z o.o. Kedzierzyn-Kozle
Poland The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow Krakow
Poland University Hospital in Krakow Krakow
Poland Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag Nowy Targ
Poland Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego Ostroleka
Poland Medicome Limited Liability Company Oswiecim
Poland Independent Public Healthcare, Dept. of Cardiology, Pulawy Pulawy
Poland American Heart of Poland Sp. z o.o. Sztum
Poland American Heart of Poland Sp. z o.o. Tychy
Poland Dr Alfred Sokolowski Specialist Hospital Walbrzych
Poland Central Hospital of Medical Academy, Warsaw Warsaw
Poland Instytut Kardiologii, Warszawa Warsaw
Poland 4. Military Clinical Hospital with Polyclinic SP ZOZ Wroclaw
Poland Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw Wroclaw
Romania Emergency Clinical County Hospital, Baia Mare Baia Mare
Romania Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu" Balotesti
Romania Spitalul Judetean de Urgenta Braila Braila
Romania Spitalul Clinic Judetean de Urgenta Brasov Brasov
Romania Elias Emergency Hospital, Bucharest Bucharest
Romania Emergency Clinical Hospital "Bagdasar-Arseni" Bucharest
Romania Emergency University Hospital, Bucharest Bucharest
Romania Military Central Clinical Emergency Hospital Bucharest
Romania Prof.C.C.Iliescu Hospital, National Institute of Cardiology Bucharest
Romania Clincal Reabilitation Hospital, Cluj Napoca Cluj Napoca
Romania Heart Institute "Niculae Stancioiu", Cluj Napoca Cluj Napoca
Romania Spitalul Clinic Judetean, Craiova Craiova
Romania Cardiovascular Diseases Institute "Prof. Georgescu", Iasi Iasi
Romania SC Cardiomed SRL, Iasi Iasi
Romania SC Endodigest SRL Oradea
Romania Sal Med Srl Pitesti
Romania Emergency County Clinical Hospital, Sibiu Sibiu
Romania Centrul Medical Cardiomed Targu-Mures
Romania Country Clinical Emergency Hospital, Targu-Mures Targu-Mures
Romania Cardiology and Cardiovascular Rehabilitation Clinic Timisoara
Russian Federation First City Clinical Hospital named after E. E. Volosevich Arkhangelsk
Russian Federation Regional Clinical Hospital, Kirov Kirov
Russian Federation Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar Krasnodar
Russian Federation State Healthcare Institution Clinical Hosp. No. 51, Moscow Moscow
Russian Federation Reg.Clin.Hosp.n.a.Semashko Nizhniy Novgorod
Russian Federation Penza Regional Clinical Hospital named after N.N.Burdenko Penza
Russian Federation Republic Kareliya Republican Hosp. named after V.A. Baranov Petrozavodsk
Russian Federation GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan Ryazan
Russian Federation Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept. Samara
Russian Federation Saratov Regional Cardiac Center Saratov
Russian Federation Saratov State Med.Univ.n.a.Razumovskogo Saratov
Russian Federation Medical Academy named after I. Mechnikov, St. Petersburg St. Petersburg
Russian Federation Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine St. Petersburg
Russian Federation Komi Republican Cardiological Dispensary Syktyvkar
Russian Federation Regional clinical hospital, Tver Tver
Russian Federation Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia Tyumen
Russian Federation State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr Volgograd
Serbia Clinical Hospital Center Dr. Dragisa Misovic Belgrade
Serbia Clinical Medical Center Zvezdara, Belgrade Belgrade
Serbia Institute for Cardiovascular diseases Dedinje Belgrade
Serbia University Clinical Center of Serbia Belgrade
Serbia University Clinical Center of Kragujevac Kragujevac
Serbia General Hospital Leskovac Leskovac
Serbia University Clinical Center Nis Nis
Serbia Institute for Treatment and Rehabilitation, Niska Banja Niska Banja
Serbia General Hospital Pancevo Pancevo
Serbia Institute of Cardiovascular Diseases Sremska Kamenica
Serbia General Hospital Sremska Mitrovica Sremska Mitrovica
Serbia General Hospital Subotica, Internal Medicine Subotica
Serbia Health Center Uzice Uzice
Serbia Health Centre Zajecar Zajecar
Serbia General Hospital - Djordje Joanovic Zrenjanin
Spain Hospital Germans Trias i Pujol Badalona
Spain University Hospital of Bellvitge Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitari Joan XXIII Tarragona
Spain Complejo Hospitalario Universitario de Vigo Vigo
Ukraine Cherkasy Regional Cardiological Center Cherkasy
Ukraine City Joint Emergency Hospital, Dnepropetrovsk Dnepropetrovsk
Ukraine Clinical Medical Diagnostic Center Simedgroup Ivano-Frankivsk
Ukraine Ivano-Frankivsk City Central Clinical Hospital Ivano-Frankivsk
Ukraine CI of Healthcare Kharkiv CCH #8, Kharkiv Kharkiv
Ukraine L.T. Malaya Institute of Therapy AMS of Ukraine Kharkiv
Ukraine Reg.Clin.Hosp.Non-Commercial Enterprise Kharkiv
Ukraine Khmelnytskyi Regional Hospital Khmelnytskyi
Ukraine City Clinical Hospital No. 1, Kiev Kiev
Ukraine Kiev City Clinical Hospital No. 5 Kiev
Ukraine Kiev Emergency Care Hospital Kiev
Ukraine SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv Kiev
Ukraine Lutsk City Clinical Hospital Lutsk
Ukraine Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital" Lviv
Ukraine Odesa Regional Clinical Hospital Odesa
Ukraine Regional Clinical Hospital, Ternopil Ternopil
Ukraine Transcarpathian Regional Clinical Center Uzhgorod
Ukraine Zhytomyr Regional Clinical Hospital, Dept. Endocrinology Zhytomyr
United States Advanced Cardiovascular LLC Alexander City Alabama
United States Texas Health Presbyterian Hospital Allen Allen Texas
United States Amarillo Heart Clinical Research Institute, Incorporated Amarillo Texas
United States Pharmatex Research Amarillo Texas
United States Asheville Cardiology Associates Asheville North Carolina
United States Grady Memorial Hospital Atlanta Georgia
United States Comprehensive Cardiovascular Medical Group Bakersfield California
United States Eastern Maine Medical Center Bangor Maine
United States Grandview Medical Center Birmingham Alabama
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Aultman Hospital Canton Ohio
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Cincinnati VA Medical Center Cincinnati Ohio
United States Clearwater Cardiovascular Consultants Clearwater Florida
United States Cardiovascular Specialists of Central Maryland Columbia Maryland
United States Missouri Cardiovascular Specialists, LLP Columbia Missouri
United States University of Missouri Health System Columbia Missouri
United States Valley Clinical Trials, Inc. Covina California
United States Dallas VA Medical Center Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Midwest Cardiovascular Research and Education Foundation Elkhart Indiana
United States Advanced Heart Care, LLC, Medicoricum, LLC Fairview Heights Illinois
United States Integrative Research Associates Fort Lauderdale Florida
United States Mercy Gilbert Medical Center Gilbert Arizona
United States Healthy Heart Cardiology Grand Rapids Michigan
United States Medication Management, LLC Greensboro North Carolina
United States Moses H. Cone Memorial Hospital Greensboro North Carolina
United States Upstate Cardiology, PA Greenville South Carolina
United States Holy Name Medical Center Hackensack New Jersey
United States Heart Center Research, LLC Huntsville Alabama
United States University of Florida Health Jacksonville Jacksonville Florida
United States Western Michigan University Kalamazoo Michigan
United States Kettering Medical Center Kettering Ohio
United States Carolina Heart Specialists, LLC Lancaster South Carolina
United States University of Kentucky Medical Center Lexington Kentucky
United States Arkansas Cardiology, PA Little Rock Arkansas
United States SJH Cardiology Associates Liverpool New York
United States Cardiovascular Innovation and Research Center Long Beach California
United States University of California Los Angeles Los Angeles California
United States University of Louisville Louisville Kentucky
United States Carient Heart and Vascular Manassas Virginia
United States Mid Michigan Medical Center Midland Michigan
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Trinity Health Center Medical Arts Minot North Dakota
United States InvivoCure Mission Hills California
United States Cardiovascular Research of Northwest Indiana, LLC Munster Indiana
United States Centennial Heart Cardiovascular Consultants, LLC Nashville Tennessee
United States Riverside Regional Medical Center Newport News Virginia
United States Tidewater Physicians Multispecialty Group Newport News Virginia
United States Sentara Hospitals Norfolk Virginia
United States North Kansas City Hospital North Kansas City Missouri
United States Valley Clinical Trials, Inc. Northridge California
United States Parkway Cardiology Associates Oak Ridge Tennessee
United States Oklahoma Heart Hospital Research Foundation, Incorporated Oklahoma City Oklahoma
United States South Oklahoma Heart Research Group Oklahoma City Oklahoma
United States Midwest Heart and Vascular Specialists Overland Park Kansas
United States Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida
United States Valley Clinical Trials, Inc. Pasadena California
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania
United States Baylor Scott and White Health Plano Texas
United States AtlantiCare Pomona New Jersey
United States Charlotte Heart Group Research Center Port Charlotte Florida
United States Cardiovascular Research of Knoxville Powell Tennessee
United States North Carolina Heart and Vascular Raleigh North Carolina
United States Monument Health Rapid City South Dakota
United States Reid Physician Associates Richmond Indiana
United States Roanoke Heart Institute PLC Roanoke Virginia
United States Shady Grove Adventist Hospital Rockville Maryland
United States Gateway Cardiology, PC Saint Louis Missouri
United States St. Louis Heart and Vascular, P.C. Saint Louis Missouri
United States South Texas Cardiovascular Consultants San Antonio Texas
United States Kaiser Permanente San Diego California
United States San Diego Cardiac Center San Diego California
United States Guthrie Medical Group PC Sayre Pennsylvania
United States Revival Research Institute, LLC. Sherman Texas
United States Stony Brook University Hospital Stony Brook New York
United States Cardiovascular Consultants of South Georgia, LLC Thomasville Georgia
United States The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Atlanta Heart Specialists, LLC Tucker Georgia
United States Cardiology Associates Research, LLC Tupelo Mississippi
United States Cardiovascular Associates of East Texas, PA Tyler Texas
United States The Heart House Vineland New Jersey
United States George Washington University Medical Faculty Associates Washington District of Columbia
United States Interventional Cardiology Medical Group West Hills California
United States Michigan Heart, PC Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  China,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of time to first heart failure hospitalisation or all-cause mortality up to 26 months
Secondary Total number of HHF or all-cause mortality up to 26 months
Secondary Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality up to 26 months
Secondary Total number of non-elective all-cause hospitalisations or all-cause mortality up to 26 months
Secondary Total number of hospitalisations for MI or all-cause mortality up to 26 months
Secondary Time to CV mortality up to 26 months
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External Links