EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

November 13, 2023 updated by: Boehringer Ingelheim

EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Myocardial Infarction

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6522

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Belgrano, Argentina, C1428ART
    - Instituto Cardiovascular de Buenos Aires
  - Ciudad Autonoma Buenos Aires, Argentina, C1180 AAX
    - Fundacion Sanatorio Güemes
  - Cordoba, Argentina, X5016KEH
    - Hospital Privado Centro Medico de Cordoba
  - Cordoba, Argentina, X5020AAA
    - Clinica Privada del Prado
  - Cordoba, Argentina, X5000
    - Hospital Italiano de Cordoba
  - Cordoba, Argentina, X5000
    - Sanatorio Allende
  - Cordoba, Argentina, X5006CBI
    - Centro Medico Luquez
  - Coronel Suarez, Argentina, B7540GHD
    - Centro de Investigacion Clinica Coronel Suarez
  - Corrientes, Argentina, 3400
    - Instituto de Cardiologia de Corrientes
  - Monserrat, Argentina, C1093AAS
    - Fundación favaloro para la Docencia e Investigación Médica
  - Quilmes, Argentina, B1878GEG
    - Sanatorio Modelo de Quilmes
  - Rosario, Argentina, S2000
    - Sanatorio Parque
  - Rosario, Argentina, S2000
    - Instituto Cardiovascular de Rosario
  - Rosario, Argentina, S2000
    - Sanatorio Delta
  - San Martin, Argentina, B1650CSP
    - Corporacion Medica de Gral. San Martin S.A.
  - San Miguel de Tucuman, Argentina, 4000
    - Centro Privado de Cardiología
  - San Nicolas, Argentina, 2900
    - Clinica U.O.M.
  - Santa Fe, Argentina, 3081
    - Sanatorio Diagnóstico
  - Santa Fé, Argentina, S3000EOZ
    - Hospital "Dr. José Maria Cullen"
  - Villa Maria, Argentina, 5900
    - Clinica Privada Fusavim SRL
Australia
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
  - Liverpool, New South Wales, Australia, 2170
    - South Western Sydney Local Health District
  - St Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital
- Queensland
  - Chermside, Queensland, Australia, 4032
    - The Prince Charles Hospital
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women's Hospital
  - Southport, Queensland, Australia, 4215
    - Gold Coast University Hospital
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Alfred Hospital
Brazil
- - Aracaju - SE, Brazil, 49055-530
    - jmf Clinica do Coracao ltda
  - Balneario Camboriu, Brazil, 88331-085
    - Hospital Santa Isabel
  - Belo Horizonte, Brazil, 30441-070
    - Hospital Madre Teresa
  - Brasilia, Brazil, 70390 700
    - Hospital do Coração do Brasil
  - Campina Grande do Sul, Brazil, 83430-000
    - Hospital Angelina Caron
  - Campinas, Brazil, 13010-001
    - Centro Especializado em Cardiol Loema Instituto de Pesq Clin
  - Campinas, Brazil, 13060-080
    - IPECC - Instituto de Pesquisa Clínica de Campinas
  - Fortaleza, Brazil, 60840-285
    - Hospital de Messejana Dr. Carlos Alberto Studart Gomes
  - Goiania, Brazil, 74605-020
    - HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
  - Joinville, Brazil, 89227-680
    - Hospital Regional Hans Dieter Schmidt
  - Marília, Brazil, 17515-000
    - Santa Casa de Misericórdia de Marília
  - Passo Fundo, Brazil, 99010-080
    - Hospital Sao Vicente de Paulo
  - Porto Alegre, Brazil, 91350-200
    - Hospital Nossa Senhora da Conceicao
  - Porto Alegre, Brazil, 90620-001
    - Instituto de Cardiologia Rio Grande do Sul
  - Porto Alegre, Brazil, 01046 010
    - Hospital Sao Lucas da PUCRS
  - Recife, Brazil, 52051-380
    - Hospital Agamenon Magalhaes
  - Ribeirao Preto, Brazil, 14051-140
    - Fundacao de apoio ao ensino e assitencia HCFMRP
  - Rio de Janeiro, Brazil, 22031-011
    - Hospital Copa D'or
  - Salvador, Brazil, 41810-011
    - Instituto de Ensino e Pesquisa do Hospital da Bahia
  - Sao Jose do Rio Preto, Brazil, 15090-000
    - Hospital de Base - Fac Med de Sao Jose do Rio Preto
  - Sao Paulo, Brazil, 05403-000
    - Hospital das Clínicas de Sao Paulo - INCOR
  - Sao Paulo, Brazil, 01333-030
    - Hospital Samaritano
  - Sao Paulo, Brazil, 04321-120
    - Hospital Sao Luiz Jabaquara
  - Sao Paulo, Brazil, 04544-000
    - Hospital Sao Luiz Morumbi
  - São Bernardo do Campo, Brazil, 09715-090
    - CEMEC - Centro Multidisciplinar de Estudos Clínicos
  - Votuporanga, Brazil, 15500-003
    - Santa Casa de Votuporanga
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Multiprofile Hospital For Active Treatment Pulse AD
  - Gabrovo, Bulgaria, 5300
    - Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
  - Haskovo, Bulgaria, 6304
    - Multiprofile Hospital for Active Treatment AD Haskovo
  - Pazardzhik, Bulgaria, 4400
    - Multiprofile Hospital For Active Treatment - Pazardzhik AD
  - Pernik, Bulgaria, 2300
    - Specialized Hospital for Active Treatment Sv. Georgi - Pernik
  - Pleven, Bulgaria, 5804
    - Multiprofile Hospital for Active Treatment Heart and Brain EAD
  - Pleven, Bulgaria, 5804
    - SHAT in Cardiology EAD, Pleven
  - Pleven, Bulgaria, 5808
    - Medical Center Medconsult Pleven LTD
  - Plovdiv, Bulgaria, 4003
    - Hospital MHAT Plovdiv, AD
  - Sofia, Bulgaria, 1407
    - City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
  - Sofia, Bulgaria, 1309
    - National Heart Hospital, Sofia
  - Sofia, Bulgaria, 1431
    - University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
  - Sofia, Bulgaria, 1527
    - UMHAT "Tsaritsa Yoannalsul"
  - Sofia, Bulgaria, 1606
    - Medical Military Academy MHAT Sofia
  - Sofia, Bulgaria, 1606
    - Multiprofile Hospital MHATEM 'Pirogov', Sofia
  - Sofia, Bulgaria, 1750
    - MHAT Sv.Anna, Clinic of Internal Diseases, Sofia
  - Stara Zagora, Bulgaria, 6004
    - Hospital Trakia Park
Canada
- - Oakville, Canada, L6M 0L8
    - Oakville Trafalgar Memorial Hospital
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Heritage Medical Research Clinic
  - Edmonton, Alberta, Canada, T5H 3V9
    - Royal Alexandra Hospital
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta Hospital (University of Alberta)
- British Columbia
  - Kamloops, British Columbia, Canada, V2C 2T1
    - Royal Inland Hospital
  - Surrey, British Columbia, Canada, V3V 0C6
    - Surrey Memorial Hospital
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver General Hospital
  - Victoria, British Columbia, Canada, V8R 1B2
    - Victoria Heart Institute Foundation
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - St. Boniface Hospital
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - GA Research Associates Ltd.
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - QEII Health Sciences Centre
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - William Osler Health Centre
  - Kingston, Ontario, Canada, K7L 2V7
    - Queen's University
  - Mississauga, Ontario, Canada, L4Y 1M3
    - One Heart Care Ventures
  - Newmarket, Ontario, Canada, L3Y 2P7
    - Southlake Regional Health Centre
  - Peterborough, Ontario, Canada, K9J 7C6
    - Peterborough Regional Health Centre
  - Scarborough, Ontario, Canada, M1B 4Z8
    - Heart Health Institute
  - Toronto, Ontario, Canada, M5S 1B2
    - Women's College Hospital
- Quebec
  - Montreal, Quebec, Canada, H2X 0A9
    - Centre Hospitalier de l'Université de Montréal (CHUM)
  - Montreal, Quebec, Canada, H1T 1C8
    - Montreal Heart Institute
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital - McGill University Health Centre
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre (MUHC)
  - Sainte-Foy, Quebec, Canada, G1V 4G5
    - IUCPQ (Laval University)
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - CIUSSS de l Estrie-CHUS
  - Terrebonne (Lachenaie), Quebec, Canada, J6V 2H2
    - CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur
  - Trois-Rivieres, Quebec, Canada, G8Z 3R9
    - CIUSSS de la Mauricie-et-du-Centre-du-Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4P 0W5
    - Prairie Vascular Research Inc.
China
- - Beijing, China, 100020
    - Beijing Chao-Yang Hospital
  - Beijing, China, 100034
    - Peking University First Hospital
  - Beijing, China, 100029
    - China-Japan Friendship Hospital
  - Beijing, China, 100022
    - Chinese PLA General hospital
  - Beijing, China, 101100
    - Beijing Luhe Hospital Capital Medical University
  - Changsha, China, 410008
    - Xiangya Hospital, Central South University
  - Changsha, China, 410007
    - Changsha Central Hospital
  - Guangzhou, China, 510100
    - Guangdong Provincial People's Hospital
  - Haerbin, China, 150001
    - The First Affiliated Hospital Of Harbin Medical University
  - Haikou, China, 570311
    - Hainan General Hospital
  - Hangzhou, China, 310013
    - Zhejiang Hospital
  - Hangzhou, China, 310016
    - Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  - Hangzhou, China, 310004
    - Shulan(Hanghzhou) Hospital
  - Lanzhou, China, 730030
    - The Second Affiliated Hospital of Lanzhou Medical University
  - Nanjing, China, 210008
    - Nanjing Drum Tower Hospital
  - Shanghai, China, 200032
    - Zhongshan Hospital Fudan University
  - Shenyang, China, 110016
    - People's Hospital of Liaoning Province
  - Shenzhen, China, 518036
    - Peking University Shenzhen Hospital
  - Wuhan, China, 430060
    - Renmin Hospital of Wuhan University
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg Universitetsshospital
  - Aarhus N, Denmark, 8200
    - Aarhus University Hospital
  - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Frederiksberg, Denmark, 2000
    - Frederiksberg Hospital
  - Herlev, Denmark, 2730
    - Herlev and Gentofte Hospital
  - Slagelse, Denmark, 4200
    - Slagelse Sygehus
France
- - Corbeil Essonnes, France, 91106
    - HOP Sud Francilien
  - Grenoble Cedex 9, France, 38043
    - HOP CHU de Grenoble
  - Lille, France, 59037
    - CHRU Lille
  - Lyon, France, 69007
    - Hospital de Saint Joseph et Saint Luc
  - Paris, France, 75018
    - HOP Bichat
  - Rouen Cedex, France, 76031
    - CHU Rouen
  - Tours, France, 37044
    - HOP Trousseau
  - Vandoeuvre-lès-Nancy, France, 54511
    - HOP Brabois
Germany
- - Bad Friedrichshall, Germany, 74177
    - SLK-Kliniken Heilbronn GmbH
  - Bad Nauheim, Germany, 61231
    - Kerckhoff-Klinik, Bad Nauheim
  - Berlin, Germany, 12203
    - Charité - Universitätsmedizin Berlin
  - Bonn, Germany, 53127
    - Universitätsklinikum Bonn AöR
  - Bremen, Germany, 28277
    - Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
  - Coburg, Germany, 96450
    - Klinikum Coburg gGmbH
  - Dortmund, Germany, 44137
    - St. Johannes Hospital Dortmund
  - Dresden, Germany, 01067
    - Städtisches Klinikum Dresden
  - Frankfurt am Main, Germany, 60596
    - Universitatsklinikum Frankfurt
  - Frankfurt/Main, Germany, 65929
    - Klinikum Frankfurt Höchst GmbH
  - Freiburg I. Breisgau, Germany, 79106
    - Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
  - Hamburg, Germany, 22307
    - Asklepios Kliniken GmbH & Co. KGaA
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Kassel, Germany, 34121
    - Ambulantes Herzzentrum Kassel
  - Leipzig, Germany, 04103
    - Universitätsklinikum Leipzig
  - Mainz, Germany, 55131
    - Katholisches Klinikum Mainz
  - Münster, Germany, 48153
    - Clemenshospital
  - Papenburg, Germany, 26871
    - Kardiologische Praxis Papenburg
  - Regensburg, Germany, 93053
    - Universitätsklinikum Regensburg
Hungary
- - Baja, Hungary, 6500
    - Lausmed Kft. Outpatient Unit of Internal Medicine
  - Budapest, Hungary, 1122
    - Semmelweis University
  - Budapest, Hungary, 1085
    - Semmelweis University
  - Budapest, Hungary, 1134
    - Magyar Honvedseg Egeszsegugyi Kozpont
  - Budapest, Hungary, 1204
    - Jahn Ferenc Del-Pest Hospital
  - Budapest, Hungary, 1023
    - Buda Hospital of the Hospitaller Order of Saint John of God
  - Budapest, Hungary, 1115
    - St. Imre Hospital, Budapest
  - Debrecen, Hungary, 4032
    - University Debrecen Hospital
  - Hodmezovasarhely, Hungary, 6800
    - Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako
  - Kaposvar, Hungary, 7400
    - Somogy County Kaposi Mór Teaching Hospital
  - Kecskemet, Hungary, 6000
    - Bacs-Kiskun Megyei Onkormanyzat Hospital
  - Kistarcsa, Hungary, 2143
    - Pest Megyei Flor Ferenc Hospital
  - Szeged, Hungary, 6720
    - University of Szeged
  - Szekesfehervar, Hungary, 8000
    - Fejer County Saint George University Teaching Hospital
  - Szolnok, Hungary, 5000
    - Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
  - Zalaegerszeg, Hungary, 8900
    - Zala County Hospital, Zalaegerszeg
India
- - Aurangabad, India, 431 010
    - Kamalnayan Bajaj Hospital
  - Bangalore, India, 560099
    - Narayana Institute of Cardiac Sciences
  - Bangalore, India, 560069
    - Sri Jayadeva Institute of Cardiovascular Sciences & Research
  - Belagavi, India, 590010
    - KLES Dr.Prabhakar Kore Hospital and Medical Research Centre
  - Chennai, India, 600037
    - Madras Medical Mission,
  - Jaipur, India, 302017
    - Eternal Heart Care Centre & Research Institute Pvt. Ltd.
  - Mumbai, India, 400012
    - KEM Hospital and Seth G S Medical College
  - Mumbai, India, 400022
    - Sion Hospital (Lokmanya Tilak Municipal Hospital)
  - Nagpur, India, 440009
    - Government Medical College & Hospital
  - New Delhi, India, 110060
    - Sir Gangaram Hospital
  - New Delhi, India, 110002
    - GB Pant Institute of Post Graduate Medical Education and Research
  - New Delhi, India, 110017
    - Max Superspeciality Hospital
  - Pune, India, 411004
    - Sahyadri Speciality Hospital
Israel
- - Afula, Israel, 18101
    - HaEmek Medical Center
  - Ashdod, Israel, 77000
    - Assuta Medical Center
  - Ashkelon, Israel, 78278
    - Barzilai Medical Center
  - Beer Sheba, Israel, 8410101
    - Soroka Univ. Medical Center
  - Beer Yaacov, Israel, 70300
    - Assaf Harofe Medical Center
  - Hadera, Israel, 38100
    - Hillel Yaffe Medical Center, Hadera
  - Haifa, Israel, 34362
    - Lady Davis Carmel Medical Center
  - Haifa, Israel, 31096
    - Rambam Medical Center
  - Haifa, Israel, 33394
    - Bnei Zion Medical Center, Haifa
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center, Jerusalem 91031
  - Jerusalem, Israel, 91120
    - Hadassah Medical Center, Ein-Karem
  - Jerusalem, Israel, 91000
    - Hadassah Medical Center, Ein-Karem
  - Kfar-Saba, Israel, 44281
    - Meir Medical Center
  - Nahariya, Israel, 22100
    - West.Galilee Med.Cent.Naharia
  - Petah Tikva, Israel, 49100
    - Rabin Medical Center Beilinson
  - Petah Tikva, Israel, 4941492
    - Rabin Medical Center Beilinson
  - Ramat Gan, Israel, 52621
    - The Chaim Sheba Medical Center Tel HaShomer
  - Rehovot, Israel, 76100
    - Kaplan Medical Center
  - Safed, Israel, 13100
    - Ziv Medical Center
  - Tel Aviv, Israel, 64239
    - Sourasky Medical Center
  - Tiberias, Israel, 15208
    - Baruch Padeh Medical Center
Japan
- - Aichi, Kasugai, Japan, 486-8510
    - Kasugai Municipal Hospital
  - Aichi, Toyota, Japan, 471-8513
    - Toyota Memorial Hospital
  - Chiba, Matsudo, Japan, 271-0077
    - Seikeikai New Tokyo Heart Clinic
  - Chiba, Matsudo, Japan, 270-2251
    - Chibanishi General Hospital
  - Fukuoka, Fukuoka, Japan, 810-0001
    - Saiseikai Fukuoka General Hospital
  - Gifu, Gifu, Japan, 500-8717
    - Gifu Prefectural General Medical Center
  - Gifu, Ogaki, Japan, 503-8502
    - Ogaki Municipal Hospital
  - Hatsukaichi, Japan, 738-8503
    - Hiroshima General Hospital
  - Hiroshima, Hiroshima, Japan, 734-8530
    - Hiroshima Prefectural Hospital
  - Hyogo, Himeji, Japan, 670-0981
    - Hyogo Brain and Heart Center
  - Ibaraki, Kasama, Japan, 309-1793
    - Ibaraki Prefectural Central Hospital
  - Ibaraki, Tsuchiura, Japan, 300-0028
    - Tsuchiura Kyodo General Hospital
  - Ishikawa, Kanazawa, Japan, 920-8530
    - Ishikawa Prefectural Central Hospital
  - Izunokuni, Japan, 410-2295
    - Juntendo University Shizuoka Hospital
  - Kanagawa, Isehara, Japan, 259-1193
    - Tokai University Hospital
  - Kanagawa, Sagamihara, Japan, 252-5188
    - Sagamihara Kyodo Hospital
  - Kanagawa, Yokohama, Japan, 232-0024
    - Yokohama City University Medical Center
  - Kasuga, Japan, 816-0864
    - Fukuoka Tokushukai Hospital
  - Kumamoto, Kumamoto, Japan, 861-4193
    - Saiseikai Kumamoto Hospital
  - Kumamoto, Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
  - Kusatsu, Japan, 525-8585
    - Kusatsu General Hospital
  - Miyazaki, Japan, 880-2102
    - Miyazaki Medical Association Hospital
  - Nagano, Nagano, Japan, 380-0814
    - Nagano Chuo Hospital
  - Osaka, Osaka, Japan, 543-0035
    - Osaka Police Hospital
  - Takamatsu, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
  - Tokushima, Japan, 770-0042
    - Tokushima Prefectural Central Hospital
  - Tokyo, Chuo-ku, Japan, 104-8560
    - St. Luke's International Hospital
  - Urayasu, Japan, 279-0001
    - Tokyo Bay Urayasu Ichikawa Medical Center
  - Yokohama, Japan, 227-8501
    - Showa University Fujigaoka Hospital
Korea, Republic of
- - Bucheon, Korea, Republic of, 14754
    - Bucheon Sejong Hospital
  - Busan, Korea, Republic of, 49241
    - Pusan National Univ. Hosp
  - Cheongiu, Korea, Republic of, 28644
    - Chungbuk National University Hospital
  - Daejoen, Korea, Republic of, 35015
    - Chungnam National University Hospital
  - Gwangju, Korea, Republic of, 61469
    - Chonnam National University Hospital
  - Seongnam, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Wonju-si, Korea, Republic of, 26426
    - Yonsei University Wonju Severance Christian Hospital
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Noordwest Ziekenhuisgroep
  - Amersfoort, Netherlands, 3813 TZ
    - Meander Medisch Centrum
  - Amsterdam, Netherlands, 1091 HA
    - Onze Lieve Vrouwe Gasthuis
  - Amsterdam, Netherlands, 1081HV
    - Amsterdam UMC locatie VUMC
  - Arnhem, Netherlands, 6815 AD
    - Rijnstate Hospital
  - Breda, Netherlands, 4819 EV
    - Amphia ziekenhuis
  - Capelle Aan Den Ijssel, Netherlands, 2906 ZC
    - IJsselland ziekenhuis
  - Eindhoven, Netherlands, 5623 EJ
    - Catharina Ziekenhuis
  - Enschede, Netherlands, 7513 ER
    - Medisch Spectrum Twente
  - Goes, Netherlands, 4462 RA
    - Admiraal de Ruyter Ziekenhuis
  - Groningen, Netherlands, 9713 GZ
    - Universitair Medisch Centrum Groningen
  - Haarlem, Netherlands, 2035 RC
    - Spaarne Ziekenhuis
  - Heerlen, Netherlands, 6419 PC
    - Zuyderland Medisch Centrum
  - Hertogenbosch, Netherlands, 5223 GZ
    - Jeroen Bosch Ziekenhuis-Hertogenbosch
  - Hilversum, Netherlands, 1213 XZ
    - Tergooi Ziekenhuis
  - Hoorn, Netherlands, 1624 NP
    - Vasculair Onderzoek Centrum
  - Leeuwarden, Netherlands, 8934 AD
    - Medisch Centrum Leeuwarden
  - Leiden, Netherlands, 2334 CK
    - Alrijne Ziekenhuis
  - Leiden, Netherlands, 2300 RC
    - Leids Universitair Medisch Centrum (LUMC)
  - Tiel, Netherlands, 4002 WP
    - Ziekenhuis Rivierenland
  - Tilburg, Netherlands, 5042 AD
    - Tweesteden Ziekenhuis, locatie Tilburg
  - Zwolle, Netherlands, 8025 AB
    - Isala Zwolle
Poland
- - Belchatow, Poland, 97-400
    - American Heart of Poland
  - Bialystok, Poland, 15-276
    - Univ. Clinic Hosp, Bialystok
  - Bielsko-Biala, Poland, 43-316
    - American Heart of Poland Sp. z o.o.
  - Chorzow, Poland, 32-500
    - American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
  - Dabrowa Gornicza, Poland, 41-300
    - American Heart of Poland Sp. z o.o.
  - Gdynia, Poland, 81-423
    - NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
  - Katowice, Poland, 40-635
    - Silesian Medical University in Katowice
  - Kedzierzyn-Kozle, Poland, 47-200
    - American Heart of Poland Sp. z o.o.
  - Krakow, Poland, 30-688
    - University Hospital in Krakow
  - Krakow, Poland, 31-202
    - The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
  - Nowy Targ, Poland, 34-400
    - Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag
  - Ostroleka, Poland, 07-410
    - Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
  - Oswiecim, Poland, 32-600
    - Medicome Limited Liability Company
  - Pulawy, Poland, 24-100
    - Independent Public Healthcare, Dept. of Cardiology, Pulawy
  - Sztum, Poland, 82-400
    - American Heart of Poland Sp. z o.o.
  - Tychy, Poland, 43-100
    - American Heart of Poland Sp. z o.o.
  - Walbrzych, Poland, 58-309
    - Dr Alfred Sokołowski Specialist Hospital
  - Warsaw, Poland, 02-097
    - Central Hospital of Medical Academy, Warsaw
  - Warsaw, Poland, 04-628
    - Instytut Kardiologii, Warszawa
  - Wroclaw, Poland, 50-981
    - 4. Military Clinical Hospital with Polyclinic SP ZOZ
  - Wroclaw, Poland, 50-556
    - Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw
Romania
- - Baia Mare, Romania, 430031
    - Emergency Clinical County Hospital, Baia Mare
  - Balotesti, Romania, 077016
    - Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
  - Braila, Romania, 810325
    - Spitalul Județean de Urgență Brăila
  - Brasov, Romania, 500326
    - Spitalul Clinic Judetean de Urgenta Brasov
  - Bucharest, Romania, 010825
    - Military Central Clinical Emergency Hospital
  - Bucharest, Romania, 050098
    - Emergency University Hospital, Bucharest
  - Bucharest, Romania, 011461
    - Elias Emergency Hospital, Bucharest
  - Bucharest, Romania, 022322
    - Prof.C.C.Iliescu Hospital, National Institute of Cardiology
  - Bucharest, Romania, 041915
    - Emergency Clinical Hospital "Bagdasar-Arseni"
  - Cluj Napoca, Romania, 400001
    - Heart Institute "Niculae Stancioiu", Cluj Napoca
  - Cluj Napoca, Romania, 400347
    - Clincal Reabilitation Hospital, Cluj Napoca
  - Craiova, Romania, 200642
    - Spitalul Clinic Judetean, Craiova
  - Iasi, Romania, 700503
    - Cardiovascular Diseases Institute "Prof. Georgescu", Iasi
  - Iasi, Romania, 700732
    - SC Cardiomed SRL, Iasi
  - Oradea, Romania, 410151
    - SC Endodigest SRL
  - Pitesti, Romania, 110437
    - Sal Med Srl
  - Sibiu, Romania, 550245
    - Emergency County Clinical Hospital, Sibiu
  - Targu-Mures, Romania, 540124
    - Centrul Medical Cardiomed
  - Targu-Mures, Romania, 540136
    - Country Clinical Emergency Hospital, Targu-Mures
  - Timisoara, Romania, 300310
    - Cardiology and Cardiovascular Rehabilitation Clinic
Russian Federation
- - Arkhangelsk, Russian Federation, 163001
    - First City Clinical Hospital named after E. E. Volosevich
  - Kirov, Russian Federation, 610014
    - Regional Clinical Hospital, Kirov
  - Krasnodar, Russian Federation, 350086
    - Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar
  - Moscow, Russian Federation, 121309
    - State Healthcare Institution Clinical Hosp. No. 51, Moscow
  - Nizhniy Novgorod, Russian Federation, 603126
    - Reg.Clin.Hosp.n.a.Semashko
  - Penza, Russian Federation, 440026
    - Penza Regional Clinical Hospital named after N.N.Burdenko
  - Petrozavodsk, Russian Federation, 185019
    - Republic Kareliya Republican Hosp. named after V.A. Baranov
  - Ryazan, Russian Federation, 390039
    - GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan
  - Samara, Russian Federation, 443070
    - Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
  - Saratov, Russian Federation, 410012
    - Saratov State Med.Univ.n.a.Razumovskogo
  - Saratov, Russian Federation, 410039
    - Saratov Regional Cardiac Center
  - St. Petersburg, Russian Federation, 195067
    - Medical Academy named after I. Mechnikov, St. Petersburg
  - St. Petersburg, Russian Federation, 192242
    - Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
  - Syktyvkar, Russian Federation, 167981
    - Komi Republican Cardiological Dispensary
  - Tver, Russian Federation, 170036
    - Regional clinical hospital, Tver
  - Tyumen, Russian Federation, 625026
    - Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
  - Volgograd, Russian Federation, 400062
    - State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
Serbia
- - Belgrade, Serbia, 11000
    - University Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Institute for Cardiovascular Diseases Dedinje
  - Belgrade, Serbia, 11040
    - Clinical Hospital Center Dr. Dragisa Misovic
  - Belgrade, Serbia, 11050
    - Clinical Medical Center Zvezdara, Belgrade
  - Kragujevac, Serbia, 34000
    - University Clinical Center of Kragujevac
  - Leskovac, Serbia, 16000
    - General Hospital Leskovac
  - Nis, Serbia, 18000
    - University Clinical Center Nis
  - Niska Banja, Serbia, 18205
    - Institute for Treatment and Rehabilitation, Niska Banja
  - Pancevo, Serbia, 26101
    - General Hospital Pancevo
  - Sremska Kamenica, Serbia, 21204
    - Institute of Cardiovascular Diseases
  - Sremska Mitrovica, Serbia, 22000
    - General Hospital Sremska Mitrovica
  - Subotica, Serbia, 24107
    - General Hospital Subotica, Internal Medicine
  - Uzice, Serbia, 31000
    - Health Center Uzice
  - Zajecar, Serbia, 19000
    - Health Centre Zajecar
  - Zrenjanin, Serbia, 23101
    - General Hospital - Djordje Joanovic
Spain
- - Badalona, Spain, 08916
    - Hospital Germans Trias i Pujol
  - Barcelona, Spain, 08907
    - University Hospital of Bellvitge
  - Madrid, Spain, 28041
    - Hospital Universitario 12 De Octubre
  - Tarragona, Spain, 43005
    - Hospital Universitari Joan Xxiii
  - Vigo, Spain, 36213
    - Complejo Hospitalario Universitario de Vigo
Ukraine
- - Cherkasy, Ukraine, 18009
    - Cherkasy Regional Cardiological Center
  - Dnepropetrovsk, Ukraine, 49006
    - City Joint Emergency Hospital, Dnepropetrovsk
  - Ivano-Frankivsk, Ukraine, 76005
    - Ivano-Frankivsk City Central Clinical Hospital
  - Ivano-Frankivsk, Ukraine, 76008
    - Clinical Medical Diagnostic Center Simedgroup
  - Kharkiv, Ukraine, 61039
    - L.T. Malaya Institute of Therapy AMS of Ukraine
  - Kharkiv, Ukraine, 61176
    - CI of Healthcare Kharkiv CCH #8, Kharkiv
  - Kharkiv, Ukraine, 61058
    - Reg.Clin.Hosp.Non-Commercial Enterprise
  - Khmelnytskyi, Ukraine, 29007
    - Khmelnytskyi Regional Hospital
  - Kiev, Ukraine, 03115
    - Kiev City Clinical Hospital No. 5
  - Kiev, Ukraine, 03680
    - SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
  - Kiev, Ukraine, 2091
    - City Clinical Hospital No. 1, Kiev
  - Kiev, Ukraine, 2166
    - Kiev Emergency Care Hospital
  - Lutsk, Ukraine, 43024
    - Lutsk City Clinical Hospital
  - Lviv, Ukraine, 79015
    - Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
  - Odesa, Ukraine, 65025
    - Odesa Regional Clinical Hospital
  - Ternopil, Ukraine, 46001
    - Regional Clinical Hospital, Ternopil
  - Uzhgorod, Ukraine, 88000
    - Transcarpathian Regional Clinical Center
  - Zhytomyr, Ukraine, 10002
    - Zhytomyr Regional Clinical Hospital, Dept. Endocrinology
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Advanced Cardiovascular LLC
  - Birmingham, Alabama, United States, 35243
    - Grandview Medical Center
  - Huntsville, Alabama, United States, 35801
    - Heart Center Research, LLC
- Arizona
  - Gilbert, Arizona, United States, 85297
    - Mercy Gilbert Medical Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Cardiology, PA
- California
  - Bakersfield, California, United States, 93309
    - Comprehensive Cardiovascular Medical Group
  - Covina, California, United States, 91723
    - Valley Clinical Trials, Inc.
  - Long Beach, California, United States, 90813
    - Cardiovascular Innovation and Research Center
  - Los Angeles, California, United States, 90095
    - University of California Los Angeles
  - Mission Hills, California, United States, 91346
    - InvivoCure
  - Northridge, California, United States, 91325
    - Valley Clinical Trials, Inc.
  - Pasadena, California, United States, 91105
    - Valley Clinical Trials, Inc.
  - San Diego, California, United States, 92123
    - San Diego Cardiac Center
  - San Diego, California, United States, 92123
    - Kaiser Permanente
  - Torrance, California, United States, 90502
    - The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  - West Hills, California, United States, 91307
    - Interventional Cardiology Medical Group
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - George Washington University Medical Faculty Associates
- Florida
  - Clearwater, Florida, United States, 33756
    - Clearwater Cardiovascular Consultants
  - Fort Lauderdale, Florida, United States, 33312
    - Integrative Research Associates
  - Jacksonville, Florida, United States, 32209
    - University of Florida Health Jacksonville
  - Palm Beach Gardens, Florida, United States, 33410
    - Cardiology Partners Clinical Research Institute
  - Port Charlotte, Florida, United States, 33952
    - Charlotte Heart Group Research Center
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Grady Memorial Hospital
  - Thomasville, Georgia, United States, 31792
    - Cardiovascular Consultants of South Georgia, LLC
  - Tucker, Georgia, United States, 30084
    - Atlanta Heart Specialists, LLC
- Illinois
  - Fairview Heights, Illinois, United States, 62208
    - Advanced Heart Care, LLC, Medicoricum, LLC
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Midwest Cardiovascular Research and Education Foundation
  - Munster, Indiana, United States, 46321
    - Cardiovascular Research of Northwest Indiana, LLC
  - Richmond, Indiana, United States, 47374
    - Reid Physician Associates
- Kansas
  - Overland Park, Kansas, United States, 66211
    - Midwest Heart and Vascular Specialists
- Kentucky
  - Lexington, Kentucky, United States, 40536-0200
    - University of Kentucky Medical Center
  - Louisville, Kentucky, United States, 40202
    - University of Louisville
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
- Maryland
  - Columbia, Maryland, United States, 21044
    - Cardiovascular Specialists of Central Maryland
  - Rockville, Maryland, United States, 20850
    - Shady Grove Adventist Hospital
- Michigan
  - Grand Rapids, Michigan, United States, 49546
    - Healthy Heart Cardiology
  - Kalamazoo, Michigan, United States, 49009
    - Western Michigan University
  - Midland, Michigan, United States, 48670
    - Mid Michigan Medical Center
  - Ypsilanti, Michigan, United States, 48197
    - Michigan Heart, PC
- Minnesota
  - Minneapolis, Minnesota, United States, 55407
    - Minneapolis Heart Institute Foundation
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - Cardiology Associates Research, LLC
- Missouri
  - Columbia, Missouri, United States, 65212
    - University of Missouri Health System
  - Columbia, Missouri, United States, 65201
    - Missouri Cardiovascular Specialists, LLP
  - North Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Saint Louis, Missouri, United States, 63136
    - St. Louis Heart and Vascular, P.C.
  - Saint Louis, Missouri, United States, 63128
    - Gateway Cardiology, PC
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Holy Name Medical Center
  - Pomona, New Jersey, United States, 08240
    - AtlantiCare
  - Vineland, New Jersey, United States, 08360
    - The Heart House
- New York
  - Liverpool, New York, United States, 13088
    - SJH Cardiology Associates
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Hospital
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Asheville Cardiology Associates
  - Chapel Hill, North Carolina, United States, 27517
    - The University of North Carolina at Chapel Hill
  - Durham, North Carolina, United States, 27705
    - Duke University Medical Center
  - Greensboro, North Carolina, United States, 27401
    - Moses H. Cone Memorial Hospital
  - Greensboro, North Carolina, United States, 27405
    - Medication Management, LLC
  - Raleigh, North Carolina, United States, 27607
    - North Carolina Heart and Vascular
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Health Center Medical Arts
- Ohio
  - Canton, Ohio, United States, 44710
    - Aultman Hospital
  - Cincinnati, Ohio, United States, 45220
    - Cincinnati VA Medical Center
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73135
    - South Oklahoma Heart Research Group
  - Oklahoma City, Oklahoma, United States, 73120
    - Oklahoma Heart Hospital Research Foundation, Incorporated
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Capital Area Research, LLC
  - Philadelphia, Pennsylvania, United States, 19104
    - Penn Presbyterian Medical Center
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Medical Group PC
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Upstate Cardiology, PA
  - Lancaster, South Carolina, United States, 29720
    - Carolina Heart Specialists, LLC
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Monument Health
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Centennial Heart Cardiovascular Consultants, LLC
  - Oak Ridge, Tennessee, United States, 37830
    - Parkway Cardiology Associates
  - Powell, Tennessee, United States, 37849
    - Cardiovascular Research of Knoxville
- Texas
  - Allen, Texas, United States, 75013
    - Texas Health Presbyterian Hospital Allen
  - Amarillo, Texas, United States, 79109
    - PharmaTex Research
  - Amarillo, Texas, United States, 79106
    - Amarillo Heart Clinical Research Institute, Incorporated
  - Dallas, Texas, United States, 75216
    - Dallas VA Medical Center
  - Plano, Texas, United States, 75093
    - Baylor Scott and White Health
  - San Antonio, Texas, United States, 78201
    - South Texas Cardiovascular Consultants
  - Sherman, Texas, United States, 75092
    - Revival Research Institute, LLC.
  - Tyler, Texas, United States, 75701
    - Cardiovascular Associates of East Texas, PA
- Virginia
  - Manassas, Virginia, United States, 20109
    - Carient Heart and Vascular
  - Newport News, Virginia, United States, 23601
    - Riverside Regional Medical Center
  - Newport News, Virginia, United States, 23606
    - Tidewater Physicians Multispecialty Group
  - Norfolk, Virginia, United States, 23507
    - Sentara Hospitals
  - Roanoke, Virginia, United States, 24014
    - Roanoke Heart Institute PLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
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.
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.
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.
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:

Diagnosis of chronic Heart Failure (HF) prior to index MI.
Systolic blood pressure < 90 mmHg at randomisation.
Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
Coronary Artery Bypass Grafting planned at time of randomisation.
Current diagnosis of Takotsubo cardiomyopathy.
Any current severe (stenotic or regurgitant) valvular heart disease.
eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
Type I diabetes mellitus. Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo
Experimental: Empagliflozin	Drug: Empagliflozin Empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of time to first heart failure hospitalisation or all-cause mortality Time Frame: up to 26 months	up to 26 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of HHF or all-cause mortality Time Frame: up to 26 months	up to 26 months
Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality Time Frame: up to 26 months	up to 26 months
Total number of non-elective all-cause hospitalisations or all-cause mortality Time Frame: up to 26 months	up to 26 months
Total number of hospitalisations for MI or all-cause mortality Time Frame: up to 26 months	up to 26 months
Time to CV mortality Time Frame: up to 26 months	up to 26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Actual)

November 5, 2023

Study Completion (Actual)

November 5, 2023

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1245-0202
2019-001037-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

IPD Sharing Time Frame

After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations