AzTrials
AzTrials

Myocardial InfarctionPhase 3NCT04509674

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)

A Phase 3 study testing Empagliflozin in people with Myocardial Infarction, run by Boehringer Ingelheim at 439 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Empagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,522 participants
Where
439 sitesin 22 countries
Study dates
16 Dec 2020to 5 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
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  • OR
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

439 sites in 22 countries.

439 sites in 22 countries

United States85 sites

  • Advanced Cardiovascular LLC

    Alexander City, Alabama, 35010

  • Texas Health Presbyterian Hospital Allen

    Allen, Texas, 75013

  • Amarillo Heart Clinical Research Institute, Incorporated

    Amarillo, Texas, 79106

  • Pharmatex Research

    Amarillo, Texas, 79109

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Comprehensive Cardiovascular Medical Group

    Bakersfield, California, 93309

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Aultman Hospital

    Canton, Ohio, 44710

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Cardiovascular Specialists of Central Maryland

    Columbia, Maryland, 21044

  • Missouri Cardiovascular Specialists, LLP

    Columbia, Missouri, 65201

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

  • Advanced Heart Care, LLC, Medicoricum, LLC

    Fairview Heights, Illinois, 62208

  • Integrative Research Associates

    Fort Lauderdale, Florida, 33312

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Healthy Heart Cardiology

    Grand Rapids, Michigan, 49546

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Medication Management, LLC

    Greensboro, North Carolina, 27405

  • Upstate Cardiology, PA

    Greenville, South Carolina, 29607

  • Holy Name Medical Center

    Hackensack, New Jersey, 07601

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Western Michigan University

    Kalamazoo, Michigan, 49009

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Carolina Heart Specialists, LLC

    Lancaster, South Carolina, 29720

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536-0200

  • Arkansas Cardiology, PA

    Little Rock, Arkansas, 72205

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Cardiovascular Innovation and Research Center

    Long Beach, California, 90813

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Carient Heart and Vascular

    Manassas, Virginia, 20109

  • Mid Michigan Medical Center

    Midland, Michigan, 48670

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Trinity Health Center Medical Arts

    Minot, North Dakota, 58701

  • InvivoCure

    Mission Hills, California, 91346

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321

  • Centennial Heart Cardiovascular Consultants, LLC

    Nashville, Tennessee, 37203

  • Riverside Regional Medical Center

    Newport News, Virginia, 23601

  • Tidewater Physicians Multispecialty Group

    Newport News, Virginia, 23606

  • Sentara Hospitals

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Parkway Cardiology Associates

    Oak Ridge, Tennessee, 37830

  • Oklahoma Heart Hospital Research Foundation, Incorporated

    Oklahoma City, Oklahoma, 73120

  • South Oklahoma Heart Research Group

    Oklahoma City, Oklahoma, 73135

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410

  • Valley Clinical Trials, Inc.

    Pasadena, California, 91105

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Baylor Scott and White Health

    Plano, Texas, 75093

  • AtlantiCare

    Pomona, New Jersey, 08240

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, 33952

  • Cardiovascular Research of Knoxville

    Powell, Tennessee, 37849

  • North Carolina Heart and Vascular

    Raleigh, North Carolina, 27607

  • Monument Health

    Rapid City, South Dakota, 57701

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • Roanoke Heart Institute PLC

    Roanoke, Virginia, 24014

  • Shady Grove Adventist Hospital

    Rockville, Maryland, 20850

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Kaiser Permanente

    San Diego, California, 92123

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Guthrie Medical Group PC

    Sayre, Pennsylvania, 18840

  • Revival Research Institute, LLC.

    Sherman, Texas, 75092

  • Gateway Cardiology, PC

    St Louis, Missouri, 63128

  • St. Louis Heart and Vascular, P.C.

    St Louis, Missouri, 63136

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Cardiovascular Consultants of South Georgia, LLC

    Thomasville, Georgia, 31792

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Atlanta Heart Specialists, LLC

    Tucker, Georgia, 30084

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • Cardiovascular Associates of East Texas, PA

    Tyler, Texas, 75701

  • The Heart House

    Vineland, New Jersey, 08360

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

  • Michigan Heart, PC

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan29 sites

  • Kasugai Municipal Hospital

    Aichi, Kasugai, 486-8510

  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513

  • Chibanishi General Hospital

    Chiba, Matsudo, 270-2251

  • Seikeikai New Tokyo Heart Clinic

    Chiba, Matsudo, 271-0077

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka, 810-0001

  • Gifu Prefectural General Medical Center

    Gifu, Gifu, 500-8717

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502

  • Hiroshima General Hospital

    Hatsukaichi, 738-8503

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Hyogo Brain and Heart Center

    Hyogo, Himeji, 670-0981

  • Ibaraki Prefectural Central Hospital

    Ibaraki, Kasama, 309-1793

  • Tsuchiura Kyodo General Hospital

    Ibaraki, Tsuchiura, 300-0028

  • Ishikawa Prefectural Central Hospital

    Ishikawa, Kanazawa, 920-8530

  • Juntendo University Shizuoka Hospital

    Izunokuni, 410-2295

  • Tokai University Hospital

    Kanagawa, Isehara, 259-1193

  • Sagamihara Kyodo Hospital

    Kanagawa, Sagamihara, 252-5188

  • Yokohama City University Medical Center

    Kanagawa, Yokohama, 232-0024

  • Fukuoka Tokushukai Hospital

    Kasuga, 816-0864

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Kusatsu General Hospital

    Kusatsu, 525-8585

  • Miyazaki Medical Association Hospital

    Miyazaki, 880-2102

  • Nagano Chuo Hospital

    Nagano, Nagano, 380-0814

  • Osaka Police Hospital

    Osaka, Osaka, 543-0035

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • Tokushima Prefectural Central Hospital

    Tokushima, 770-0042

  • St. Luke's International Hospital

    Tokyo, Chuo-ku, 104-8560

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu, 279-0001

  • Showa University Fujigaoka Hospital

    Yokohama, 227-8501

Other trials in Japan

Canada27 sites

  • William Osler Health Centre

    Brampton, Ontario, L6R 3J7

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2B7

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Royal Inland Hospital

    Kamloops, British Columbia, V2C 2T1

  • Queen's University

    Kingston, Ontario, K7L 2V7

  • One Heart Care Ventures

    Mississauga, Ontario, L4Y 1M3

  • GA Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P7

  • Oakville Trafalgar Memorial Hospital

    Oakville, L6M 0L8

  • Peterborough Regional Health Centre

    Peterborough, Ontario, K9J 7C6

  • Prairie Vascular Research Inc.

    Regina, Saskatchewan, S4P 0W5

  • IUCPQ (Laval University)

    Sainte-Foy, Quebec, G1V 4G5

  • Heart Health Institute

    Scarborough Village, Ontario, M1B 4Z8

  • CIUSSS de l Estrie-CHUS

    Sherbrooke, Quebec, J1H 5N4

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 0C6

  • CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur

    Terrebonne (Lachenaie), Quebec, J6V 2H2

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec

    Trois-Rivières, Quebec, G8Z 3R9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 1B2

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Brazil26 sites

  • JMF Clinica Do Coracao LTDA

    Aracaju - SE, 49055-530

  • Hospital Santa Isabel

    Balneário Camboriú, 88331-085

  • Hospital Madre Teresa

    Belo Horizonte, 30441-070

  • Hospital do Coracao do Brasil

    Brasília, 70390 700

  • Hospital Angelina Caron

    Campina Grande do Sul, 83430-000

  • Centro Especializado em Cardiol Loema Instituto de Pesq Clin

    Campinas, 13010-001

  • IPECC - Instituto de Pesquisa Clínica de Campinas

    Campinas, 13060-080

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, 60840-285

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, 74605-020

  • Hospital Regional Hans Dieter Schmidt

    Joinville, 89227-680

  • Santa Casa de Misericórdia de Marília

    Marília, 17515-000

  • Hospital São Vicente de Paulo

    Passo Fundo, 99010-080

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 01046 010

  • Instituto de Cardiologia Rio Grande do Sul

    Porto Alegre, 90620-001

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, 91350-200

  • Hospital Agamenon Magalhaes

    Recife, 52051-380

  • Fundacao de apoio ao ensino e assitencia HCFMRP

    Ribeirão Preto, 14051-140

  • Hospital Copa D'or

    Rio de Janeiro, 22031-011

  • Instituto de Ensino E Pesquisa Do Hospital Da Bahia

    Salvador, 41810-011

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09715-090

  • Hospital de Base - Fac Med de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • Hospital Samaritano

    São Paulo, 01333-030

  • Hospital Sao Luiz Jabaquara

    São Paulo, 04321-120

  • Hospital Sao Luiz Morumbi

    São Paulo, 04544-000

  • Hospital das Clínicas de Sao Paulo - INCOR

    São Paulo, 05403-000

  • Santa Casa de Votuporanga

    Votuporanga, 15500-003

Other trials in Brazil

Netherlands22 sites

  • Jeroen Bosch Ziekenhuis-Hertogenbosch

    's-Hertogenbosch, 5223 GZ

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Amsterdam UMC Locatie VUMC

    Amsterdam, 1081HV

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • IJsselland Ziekenhuis

    Capelle aan den IJssel, 2906 ZC

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Medisch Spectrum Twente

    Enschede, 7513 ER

  • Admiraal de Ruyter Ziekenhuis

    Goes, 4462 RA

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Spaarne Ziekenhuis

    Haarlem, 2035 RC

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Tergooi Ziekenhuis

    Hilversum, 1213 XZ

  • Vasculair Onderzoek Centrum

    Hoorn, 1624 NP

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2300 RC

  • Alrijne Ziekenhuis

    Leiden, 2334 CK

  • Ziekenhuis Rivierenland

    Tiel, 4002 WP

  • Tweesteden Ziekenhuis, locatie Tilburg

    Tilburg, 5042 AD

  • Isala Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

Israel21 sites

  • Haemek Medical Center

    Afula, 18101

  • Assuta Medical Center

    Ashdod, 77000

  • Barzilai Medical Center

    Ashkelon, 78278

  • Assaf Harofe Medical Center

    Beer Yaacov, 70300

  • Soroka Univ. Medical Center

    Beersheba, 8410101

  • Hillel Yaffe Medical Center, Hadera

    Hadera, 38100

  • Rambam Medical Center

    Haifa, 31096

  • Bnei Zion Medical Center, Haifa

    Haifa, 33394

  • Lady Davis Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 91000

  • Shaare Zedek Medical Center, Jerusalem 91031

    Jerusalem, 9103102

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • West.Galilee Med.Cent.Naharia

    Nahariya, 22100

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Rabin Medical Center Beilinson

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center Tel HaShomer

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Ziv Medical Center

    Safed, 13100

  • Sourasky Medical Center

    Tel Aviv, 64239

  • Baruch Padeh Medical Center

    Tiberias, 15208

Other trials in Israel

Poland21 sites

  • American Heart of Poland

    Bełchatów, 97-400

  • Univ. Clinic Hosp, Bialystok

    Bialystok, 15-276

  • American Heart of Poland Sp. z o.o.

    Bielsko-Biala, 43-316

  • American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre

    Chorzów, 32-500

  • American Heart of Poland Sp. z o.o.

    Dąbrowa Górnicza, 41-300

  • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

    Gdynia, 81-423

  • Silesian Medical University in Katowice

    Katowice, 40-635

  • American Heart of Poland Sp. z o.o.

    Kędzierzyn-Koźle, 47-200

  • University Hospital in Krakow

    Krakow, 30-688

  • The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

    Krakow, 31-202

  • Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag

    Nowy Targ, 34-400

  • Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego

    Ostrołęka, 07-410

  • Medicome Limited Liability Company

    Oświęcim, 32-600

  • Independent Public Healthcare, Dept. of Cardiology, Pulawy

    Puławy, 24-100

  • American Heart of Poland Sp. z o.o.

    Sztum, 82-400

  • American Heart of Poland Sp. z o.o.

    Tychy, 43-100

  • Dr Alfred Sokołowski Specialist Hospital

    Wałbrzych, 58-309

  • Central Hospital of Medical Academy, Warsaw

    Warsaw, 02-097

  • Instytut Kardiologii, Warszawa

    Warsaw, 04-628

  • Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw

    Wroclaw, 50-556

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981

Other trials in Poland

Argentina20 sites

  • Instituto Cardiovascular de Buenos Aires

    Belgrano, C1428ART

  • Fundacion Sanatorio Güemes

    Ciudad Autonoma Buenos Aires, C1180 AAX

  • Hospital Italiano de Córdoba

    Córdoba, X5000

  • Sanatorio Allende

    Córdoba, X5000

  • Centro Medico Luquez

    Córdoba, X5006CBI

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Clinica Privada del Prado

    Córdoba, X5020AAA

  • Centro de Investigacion Clinica Coronel Suarez

    Coronel Suárez, B7540GHD

  • Instituto de Cardiologia de Corrientes

    Corrientes, 3400

  • Fundación Favaloro para la Docencia e Investigación Medica

    Montserrat, C1093AAS

  • Sanatorio Modelo de Quilmes

    Quilmes, B1878GEG

  • Instituto Cardiovascular de Rosario

    Rosario, S2000

  • Sanatorio Delta

    Rosario, S2000

  • Sanatorio Parque

    Rosario, S2000

  • Corporacion Medica de Gral. San Martin S.A.

    San Martin, B1650CSP

  • Centro Privado de Cardiologia

    San Miguel de Tucumán, 4000

  • Clinica U.O.M.

    San Nicolás, 2900

  • Sanatorio Diagnóstico

    Santa Fe, 3081

  • Hospital "Dr. José Maria Cullen"

    Santa Fe, S3000EOZ

  • Clinica Privada Fusavim SRL

    Villa María, 5900

Other trials in Argentina

Romania20 sites

  • Emergency Clinical County Hospital, Baia Mare

    Baia Mare, 430031

  • Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"

    Baloteşti, 077016

  • Spitalul Judetean de Urgenta Braila

    Brăila, 810325

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500326

  • Military Central Clinical Emergency Hospital

    Bucharest, 010825

  • Elias Emergency Hospital, Bucharest

    Bucharest, 011461

  • Prof.C.C.Iliescu Hospital, National Institute of Cardiology

    Bucharest, 022328

  • Emergency Clinical Hospital "Bagdasar-Arseni"

    Bucharest, 041915

  • Emergency University Hospital, Bucharest

    Bucharest, 050098

  • Heart Institute "Niculae Stancioiu", Cluj Napoca

    Cluj-Napoca, 400001

  • Clincal Reabilitation Hospital, Cluj Napoca

    Cluj-Napoca, 400347

  • Spitalul Clinic Judetean, Craiova

    Craiova, 200642

  • Cardiovascular Diseases Institute "Prof. Georgescu", Iasi

    Iași, 700503

  • SC Cardiomed SRL, Iasi

    Iași, 700732

  • SC Endodigest SRL

    Oradea, 410151

  • Sal Med Srl

    Piteşti, 110424

  • Emergency County Clinical Hospital, Sibiu

    Sibiu, 550245

  • Centrul Medical Cardiomed

    Târgu Mureş, 540124

  • Country Clinical Emergency Hospital, Targu-Mures

    Târgu Mureş, 540136

  • Cardiology and Cardiovascular Rehabilitation Clinic

    Timișoara, 300310

Other trials in Romania

China19 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • Chinese PLA General Hospital

    Beijing, 100022

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Luhe Hospital Capital Medical University

    Beijing, 101100

  • Changsha Central Hospital

    Changsha, 410007

  • Xiangya Hospital, Central South University

    Changsha, 410008

  • Guangdong Provincial People's Hospital

    Guangzhou, 510100

  • The First Affiliated Hospital of Harbin Medical University

    Haerbin, 150001

  • Hainan General Hospital

    Haikou, 570311

  • Shulan(Hanghzhou) Hospital

    Hangzhou, 310004

  • Zhejiang Hospital

    Hangzhou, 310013

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016

  • The Second Affiliated Hospital of Lanzhou Medical University

    Lanzhou, 730030

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032

  • People's Hospital of Liaoning Province

    Shenyang, 110016

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

Other trials in China

Germany19 sites

  • SLK-Kliniken Heilbronn GmbH

    Bad Friedrichshall, 74177

  • Kerckhoff-Klinik, Bad Nauheim

    Bad Nauheim, 61231

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Universitätsklinikum Bonn AöR

    Bonn, 53127

  • Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser

    Bremen, 28277

  • Klinikum Coburg gGmbH

    Coburg, 96450

  • St. Johannes Hospital Dortmund

    Dortmund, 44137

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt am Main, 65929

  • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH

    Freiburg I. Breisgau, 79106

  • Asklepios Kliniken GmbH & Co. KGaA

    Hamburg, 22307

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Ambulantes Herzzentrum Kassel

    Kassel, 34121

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Katholisches Klinikum Mainz

    Mainz, 55131

  • Clemenshospital

    Münster, 48153

  • Kardiologische Praxis Papenburg

    Papenburg, 26871

  • Universitätsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Ukraine18 sites

  • Cherkasy Regional Cardiological Center

    Cherkasy, 18009

  • City Joint Emergency Hospital, Dnepropetrovsk

    Dnipro, 49006

  • Ivano-Frankivsk City Central Clinical Hospital

    Ivano-Frankivsk, 76005

  • Clinical Treatment and Diagnostic Center of the Limited Liability Company "SIMEDGROUP"

    Ivano-Frankivsk, 76008

  • L.T. Malaya Institute of Therapy AMS of Ukraine

    Kharkiv, 61039

  • Reg.Clin.Hosp.Non-Commercial Enterprise

    Kharkiv, 61058

  • CI of Healthcare Kharkiv CCH #8, Kharkiv

    Kharkiv, 61176

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi, 29007

  • Kiev City Clinical Hospital No. 5

    Kiev, 03115

  • SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv

    Kiev, 03680

  • City Clinical Hospital No. 1, Kiev

    Kiev, 2091

  • Kiev Emergency Care Hospital

    Kiev, 2166

  • Lutsk City Clinical Hospital

    Lutsk, 43024

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

    Lviv, 79015

  • Odesa Regional Clinical Hospital

    Odesa, 65025

  • Regional Clinical Hospital, Ternopil

    Ternopil, 46001

  • Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Center of Cardiology and Cardiac Surgery" of Zakarpattia Regional Council

    Uzhhorod, 88000

  • Zhytomyr Regional Clinical Hospital, Dept. Endocrinology

    Zhytomyr, 10002

Other trials in Ukraine

Bulgaria17 sites

  • Multiprofile Hospital For Active Treatment Pulse AD

    Blagoevgrad, 2700

  • Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD

    Gabrovo, 5300

  • Multiprofile Hospital for Active Treatment AD Haskovo

    Haskovo, 6304

  • Multiprofile Hospital For Active Treatment - Pazardzhik AD

    Pazardzhik, 4400

  • Specialized Hospital for Active Treatment Sv. Georgi - Pernik

    Pernik, 2300

  • Medical Center Medconsult Pleven LTD

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Heart and Brain EAD

    Pleven, 5804

  • SHAT in Cardiology EAD, Pleven

    Pleven, 5804

  • Hospital MHAT Plovdiv, AD

    Plovdiv, 4003

  • National Heart Hospital, Sofia

    Sofia, 1309

  • City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

    Sofia, 1407

  • University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD

    Sofia, 1431

  • UMHAT "Tsaritsa Yoannalsul"

    Sofia, 1527

  • Medical Military Academy MHAT Sofia

    Sofia, 1606

  • Multiprofile Hospital MHATEM 'Pirogov', Sofia

    Sofia, 1606

  • MHAT Sv.Anna, Clinic of Internal Diseases, Sofia

    Sofia, 1750

  • Hospital Trakia Park

    Stara Zagora, 6004

Other trials in Bulgaria

Russia17 sites

  • First City Clinical Hospital named after E. E. Volosevich

    Arkhangelsk, 163001

  • Regional Clinical Hospital, Kirov

    Kirov, 610014

  • Regional Clinical Hospital No.1 named after Professor. S.V. Ochapovskiy

    Krasnodar, 350086

  • State Healthcare Institution Clinical Hosp. No. 51, Moscow

    Moscow, 121309

  • Reg.Clin.Hosp.n.a.Semashko

    Nizhny Novgorod, 603126

  • Penza Regional Clinical Hospital named after N.N.Burdenko

    Penza, 440026

  • Republic Kareliya Republican Hosp. named after V.A. Baranov

    Petrozavodsk, 185019

  • GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan

    Ryazan, 390039

  • Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

    Saint Petersburg, 192242

  • Medical Academy named after I. Mechnikov, St. Petersburg

    Saint Petersburg, 195067

  • Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.

    Samara, 443070

  • Saratov State Med.Univ.n.a.Razumovskogo

    Saratov, 410012

  • Saratov Regional Cardiac Center

    Saratov, 410039

  • Komi Republican Cardiological Dispensary

    Syktyvkar, 167981

  • Regional clinical hospital, Tver

    Tver', 170036

  • Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

    Tyumen, 625026

  • State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

    Volgograd, 400062

Other trials in Russia

Hungary16 sites

  • Lausmed Kft. Outpatient Unit of Internal Medicine

    Baja, 6500

  • Buda Hospital of the Hospitaller Order of Saint John of God

    Budapest, 1023

  • Semmelweis University

    Budapest, 1085

  • St. Imre Hospital, Budapest

    Budapest, 1115

  • Semmelweis University

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

  • Jahn Ferenc Del-Pest Hospital

    Budapest, 1204

  • University Debrecen Hospital

    Debrecen, 4032

  • Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako

    Hódmezővásárhely, 6800

  • Somogy County Kaposi Mor Teaching Hospital

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Onkormanyzat Hospital

    Kecskemét, 6000

  • Pest Megyei Flor Ferenc Hospital

    Kistarcsa, 2143

  • University of Szeged

    Szeged, 6720

  • Fejer County Saint George University Teaching Hospital

    Székesfehérvár, 8000

  • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet

    Szolnok, 5000

  • Zala County Hospital, Zalaegerszeg

    Zalaegerszeg, 8900

Other trials in Hungary

Serbia15 sites

  • Institute for Cardiovascular diseases Dedinje

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Center Dr. Dragisa Misovic

    Belgrade, 11040

  • Clinical Medical Center Zvezdara, Belgrade

    Belgrade, 11050

  • Institute of Cardiovascular Diseases

    Kamenitz, 21204

  • University Clinical Center of Kragujevac

    Kragujevac, 34000

  • General Hospital Leskovac

    Leskovac, 16000

  • University Clinical Center Nis

    Niš, 18000

  • Institute for Treatment and Rehabilitation, Niska Banja

    Niška Banja, 18205

  • General Hospital Pancevo

    Pančevo, 26101

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica, 22000

  • General Hospital Subotica, Internal Medicine

    Subotica, 24107

  • Health Center Uzice

    Užice, 31000

  • Health Centre Zajecar

    Zaječar, 19000

  • General Hospital - Djordje Joanovic

    Zrenjanin, 23101

Other trials in Serbia

India13 sites

  • Kamalnayan Bajaj Hospital

    Aurangabad, 431 010

  • Sri Jayadeva Institute of Cardiovascular Sciences & Research

    Bangalore, 560069

  • Narayana Institute of Cardiac Sciences

    Bangalore, 560099

  • KLES Dr.Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, 590010

  • Madras Medical Mission,

    Chennai, 600037

  • Eternal Heart Care Centre & Research Institute Pvt. Ltd.

    Jaipur, 302017

  • KEM Hospital and Seth G S Medical College

    Mumbai, 400012

  • Sion Hospital (Lokmanya Tilak Municipal Hospital)

    Mumbai, 400022

  • Government Medical College & Hospital

    Nagpur, 440009

  • GB Pant Institute of Post Graduate Medical Education and Research

    New Delhi, 110002

  • Max Superspeciality Hospital

    New Delhi, 110017

  • Sir Gangaram Hospital

    New Delhi, 110060

  • Sahyadri Speciality Hospital

    Pune, 411004

Other trials in India

Australia8 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • South Western Sydney Local Health District

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France8 sites

  • HOP Sud Francilien

    Corbeil-Essonnes, 91106

  • HOP CHU de Grenoble

    Grenoble, 38043

  • CHRU Lille

    Lille, 59037

  • Hospital de Saint Joseph et Saint Luc

    Lyon, 69007

  • HOP Bichat

    Paris, 75018

  • CHU Rouen

    Rouen, 76031

  • HOP Trousseau

    Tours, 37044

  • HOP Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

South Korea7 sites

  • Bucheon Sejong Hospital

    Bucheon-si, 14754

  • Pusan National Univ. Hosp

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongiu, 28644

  • Chungnam National University Hospital

    Daejoen, 35015

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon State, 26426

Other trials in South Korea

Denmark6 sites

  • Aalborg Universitetsshospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Herlev and Gentofte Hospital

    Herlev, 2730

  • Slagelse Sygehus

    Slagelse, 4200

Other trials in Denmark

Spain5 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • University Hospital of Bellvitge

    Barcelona, 08907

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitari Joan XXIII

    Tarragona, 43005

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36213

Other trials in Spain

About this study

Official title: 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.

Being tested
Empagliflozin, Placebo
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Empagliflozin

  • PlaceboDrug

    Placebo

Study groups in NCT04509674
Study groupRoleWhat they receive
Empagliflozin 10 mgExperimentalNot described
Receives: Drug: Empagliflozin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality

    The composite of time to first heart failure hospitalization or all-cause mortality is reported as the incidence rate of the first occurrence of hospitalization for heart failure (HHF) or death, whichever is earliest.

    The incidence rate was calculated as: the number of patients with an event for hospitalization for heart failure or death by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Secondary outcomes (5)

  1. Key Secondary Endpoint - Total Number of Hospitalisations for Heart Failure (HHF) or All-cause Mortality

    The total number of hospitalisations for heart failure (HHF) or all-cause mortality is reported using the adjusted event rate.

    The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

  2. Key Secondary Endpoint - Total Number of Non-elective Cardiovascular (CV) Hospitalisations or All-cause Mortality

    The total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality is reported using the adjusted event rate.

    The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

  3. Key Secondary Endpoint - Total Number of Non-elective All-cause Hospitalisations or All-cause Mortality

    The total number of non-elective all-cause hospitalisations or all-cause mortality is reported using the adjusted event rate.

    The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

  4. Key Secondary Endpoint - Total Number of Hospitalisations for Myocardial Infarction (MI) or All-cause Mortality

    The total number of hospitalisations for myocardial infarction (MI) or all-cause mortality is reported using the adjusted event rate.

    The adjusted event rate is based on a negative binomial model adjusted for factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

  5. Time to Cardiovascular (CV) Mortality

    The time to cardiovascular (CV) mortality is reported as the incidence rate of cardiovascular (CV) mortality, including deaths of unknown cause.

    The incidence rate was calculated as: the number of patients with a cardiovascular death event by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).

    Measured: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start16 Dec 2020
  3. Primary completion5 Nov 2023
  4. Study completion5 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509674
Sponsor's protocol ID
1245-0202
Other IDs
2019-001037-13, 2019
Status last verified
Dec 2024
First submitted
10 Aug 2020
Last updated
7 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Udell JA, Petrie MC, Jones WS, Anker SD, Harrington J, Mattheus M, Seide S, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, Figtree G, Ge J, Goodman SG, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Martinez-Traba M, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Hernandez AF, Butler J. Left Ventricular Function, Congestion, and Effect of Empagliflozin on Heart Failure Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Jun 11;83(23):2233-2246. doi: 10.1016/j.jacc.2024.03.405. Epub 2024 Apr 6.

    PubMed 38588929

  • Butler J, Jones WS, Udell JA, Anker SD, Petrie MC, Harrington J, Mattheus M, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, Figtree G, Ge J, Goodman SG, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Hernandez AF. Empagliflozin after Acute Myocardial Infarction. N Engl J Med. 2024 Apr 25;390(16):1455-1466. doi: 10.1056/NEJMoa2314051. Epub 2024 Apr 6.

    PubMed 38587237

  • Hernandez AF, Udell JA, Jones WS, Anker SD, Petrie MC, Harrington J, Mattheus M, Seide S, Zwiener I, Amir O, Bahit MC, Bauersachs J, Bayes-Genis A, Chen Y, Chopra VK, A Figtree G, Ge J, G Goodman S, Gotcheva N, Goto S, Gasior T, Jamal W, Januzzi JL, Jeong MH, Lopatin Y, Lopes RD, Merkely B, Parikh PB, Parkhomenko A, Ponikowski P, Rossello X, Schou M, Simic D, Steg PG, Szachniewicz J, van der Meer P, Vinereanu D, Zieroth S, Brueckmann M, Sumin M, Bhatt DL, Butler J. Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial. Circulation. 2024 May 21;149(21):1627-1638. doi: 10.1161/CIRCULATIONAHA.124.069217. Epub 2024 Apr 6.

    PubMed 38581389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Myocardial Infarction, run by Boehringer Ingelheim at 439 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 439 sites in United States, Japan, Canada, Brazil, Netherlands and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality (time frame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509674, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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