Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04509674




Registration number
NCT04509674
Ethics application status
Date submitted
10/08/2020
Date registered
12/08/2020
Date last updated
14/11/2023

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
2019-001037-13
Secondary ID [2] 0 0
1245-0202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo

Experimental: Empagliflozin -

Placebo comparator: Placebo -


Treatment: Drugs: Empagliflozin
Empagliflozin

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of time to first heart failure hospitalisation or all-cause mortality
Timepoint [1] 0 0
up to 26 months
Secondary outcome [1] 0 0
Total number of HHF or all-cause mortality
Timepoint [1] 0 0
up to 26 months
Secondary outcome [2] 0 0
Total number of non-elective Cardiovascular (CV) hospitalisations or all-cause mortality
Timepoint [2] 0 0
up to 26 months
Secondary outcome [3] 0 0
Total number of non-elective all-cause hospitalisations or all-cause mortality
Timepoint [3] 0 0
up to 26 months
Secondary outcome [4] 0 0
Total number of hospitalisations for MI or all-cause mortality
Timepoint [4] 0 0
up to 26 months
Secondary outcome [5] 0 0
Time to CV mortality
Timepoint [5] 0 0
up to 26 months

Eligibility
Key inclusion criteria
1. Of full age of consent (according to local legislation, at least = 18 years) at screening.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
4. Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
5. High risk of HF, defined as EITHER

1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.

OR
2. Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
6. In addition at least one of the following risk factors:

* Age > 65 years,
* Newly developed LVEF < 35%,
* Prior MI (before index MI) documented in medical records,
* Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
* Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
* Type 2 diabetes mellitus (prior or new diagnosis),
* N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
* Uric acid >7.5 mg/dL (>446 µmol/L), measured at any time during hospitalisation,
* Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation),
* Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
* 3-vessel coronary artery disease at time of index MI,
* Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of chronic Heart Failure (HF) prior to index MI.
2. Systolic blood pressure < 90 mmHg at randomisation.
3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
4. Coronary Artery Bypass Grafting planned at time of randomisation.
5. Current diagnosis of Takotsubo cardiomyopathy.
6. Any current severe (stenotic or regurgitant) valvular heart disease.
7. eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
8. Type I diabetes mellitus. Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/11/2023
Sample size
Target
Accrual to date
Final
6522
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
South Western Sydney Local Health District - Liverpool
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
North Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
Argentina
State/province [30] 0 0
Belgrano
Country [31] 0 0
Argentina
State/province [31] 0 0
Ciudad Autonoma Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Cordoba
Country [33] 0 0
Argentina
State/province [33] 0 0
Coronel Suarez
Country [34] 0 0
Argentina
State/province [34] 0 0
Corrientes
Country [35] 0 0
Argentina
State/province [35] 0 0
Monserrat
Country [36] 0 0
Argentina
State/province [36] 0 0
Quilmes
Country [37] 0 0
Argentina
State/province [37] 0 0
Rosario
Country [38] 0 0
Argentina
State/province [38] 0 0
San Martin
Country [39] 0 0
Argentina
State/province [39] 0 0
San Miguel de Tucuman
Country [40] 0 0
Argentina
State/province [40] 0 0
San Nicolas
Country [41] 0 0
Argentina
State/province [41] 0 0
Santa Fe
Country [42] 0 0
Argentina
State/province [42] 0 0
Santa Fé
Country [43] 0 0
Argentina
State/province [43] 0 0
Villa Maria
Country [44] 0 0
Brazil
State/province [44] 0 0
Aracaju - SE
Country [45] 0 0
Brazil
State/province [45] 0 0
Balneario Camboriu
Country [46] 0 0
Brazil
State/province [46] 0 0
Belo Horizonte
Country [47] 0 0
Brazil
State/province [47] 0 0
Brasilia
Country [48] 0 0
Brazil
State/province [48] 0 0
Campina Grande do Sul
Country [49] 0 0
Brazil
State/province [49] 0 0
Campinas
Country [50] 0 0
Brazil
State/province [50] 0 0
Fortaleza
Country [51] 0 0
Brazil
State/province [51] 0 0
Goiania
Country [52] 0 0
Brazil
State/province [52] 0 0
Joinville
Country [53] 0 0
Brazil
State/province [53] 0 0
Marília
Country [54] 0 0
Brazil
State/province [54] 0 0
Passo Fundo
Country [55] 0 0
Brazil
State/province [55] 0 0
Porto Alegre
Country [56] 0 0
Brazil
State/province [56] 0 0
Recife
Country [57] 0 0
Brazil
State/province [57] 0 0
Ribeirao Preto
Country [58] 0 0
Brazil
State/province [58] 0 0
Rio de Janeiro
Country [59] 0 0
Brazil
State/province [59] 0 0
Salvador
Country [60] 0 0
Brazil
State/province [60] 0 0
Sao Jose do Rio Preto
Country [61] 0 0
Brazil
State/province [61] 0 0
Sao Paulo
Country [62] 0 0
Brazil
State/province [62] 0 0
São Bernardo do Campo
Country [63] 0 0
Brazil
State/province [63] 0 0
Votuporanga
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Blagoevgrad
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Gabrovo
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Haskovo
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Pazardzhik
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Pernik
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Pleven
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Plovdiv
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Sofia
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Stara Zagora
Country [73] 0 0
Canada
State/province [73] 0 0
Alberta
Country [74] 0 0
Canada
State/province [74] 0 0
British Columbia
Country [75] 0 0
Canada
State/province [75] 0 0
Manitoba
Country [76] 0 0
Canada
State/province [76] 0 0
New Brunswick
Country [77] 0 0
Canada
State/province [77] 0 0
Nova Scotia
Country [78] 0 0
Canada
State/province [78] 0 0
Ontario
Country [79] 0 0
Canada
State/province [79] 0 0
Quebec
Country [80] 0 0
Canada
State/province [80] 0 0
Saskatchewan
Country [81] 0 0
Canada
State/province [81] 0 0
Oakville
Country [82] 0 0
China
State/province [82] 0 0
Beijing
Country [83] 0 0
China
State/province [83] 0 0
Changsha
Country [84] 0 0
China
State/province [84] 0 0
Guangzhou
Country [85] 0 0
China
State/province [85] 0 0
Haerbin
Country [86] 0 0
China
State/province [86] 0 0
Haikou
Country [87] 0 0
China
State/province [87] 0 0
Hangzhou
Country [88] 0 0
China
State/province [88] 0 0
Lanzhou
Country [89] 0 0
China
State/province [89] 0 0
Nanjing
Country [90] 0 0
China
State/province [90] 0 0
Shanghai
Country [91] 0 0
China
State/province [91] 0 0
Shenyang
Country [92] 0 0
China
State/province [92] 0 0
Shenzhen
Country [93] 0 0
China
State/province [93] 0 0
Wuhan
Country [94] 0 0
Denmark
State/province [94] 0 0
Aalborg
Country [95] 0 0
Denmark
State/province [95] 0 0
Aarhus N
Country [96] 0 0
Denmark
State/province [96] 0 0
Copenhagen
Country [97] 0 0
Denmark
State/province [97] 0 0
Frederiksberg
Country [98] 0 0
Denmark
State/province [98] 0 0
Herlev
Country [99] 0 0
Denmark
State/province [99] 0 0
Slagelse
Country [100] 0 0
France
State/province [100] 0 0
Corbeil Essonnes
Country [101] 0 0
France
State/province [101] 0 0
Grenoble Cedex 9
Country [102] 0 0
France
State/province [102] 0 0
Lille
Country [103] 0 0
France
State/province [103] 0 0
Lyon
Country [104] 0 0
France
State/province [104] 0 0
Paris
Country [105] 0 0
France
State/province [105] 0 0
Rouen Cedex
Country [106] 0 0
France
State/province [106] 0 0
Tours
Country [107] 0 0
France
State/province [107] 0 0
Vandoeuvre-lès-Nancy
Country [108] 0 0
Germany
State/province [108] 0 0
Bad Friedrichshall
Country [109] 0 0
Germany
State/province [109] 0 0
Bad Nauheim
Country [110] 0 0
Germany
State/province [110] 0 0
Berlin
Country [111] 0 0
Germany
State/province [111] 0 0
Bonn
Country [112] 0 0
Germany
State/province [112] 0 0
Bremen
Country [113] 0 0
Germany
State/province [113] 0 0
Coburg
Country [114] 0 0
Germany
State/province [114] 0 0
Dortmund
Country [115] 0 0
Germany
State/province [115] 0 0
Dresden
Country [116] 0 0
Germany
State/province [116] 0 0
Frankfurt am Main
Country [117] 0 0
Germany
State/province [117] 0 0
Frankfurt/Main
Country [118] 0 0
Germany
State/province [118] 0 0
Freiburg I. Breisgau
Country [119] 0 0
Germany
State/province [119] 0 0
Hamburg
Country [120] 0 0
Germany
State/province [120] 0 0
Hannover
Country [121] 0 0
Germany
State/province [121] 0 0
Kassel
Country [122] 0 0
Germany
State/province [122] 0 0
Leipzig
Country [123] 0 0
Germany
State/province [123] 0 0
Mainz
Country [124] 0 0
Germany
State/province [124] 0 0
Münster
Country [125] 0 0
Germany
State/province [125] 0 0
Papenburg
Country [126] 0 0
Germany
State/province [126] 0 0
Regensburg
Country [127] 0 0
Hungary
State/province [127] 0 0
Baja
Country [128] 0 0
Hungary
State/province [128] 0 0
Budapest
Country [129] 0 0
Hungary
State/province [129] 0 0
Debrecen
Country [130] 0 0
Hungary
State/province [130] 0 0
Hodmezovasarhely
Country [131] 0 0
Hungary
State/province [131] 0 0
Kaposvar
Country [132] 0 0
Hungary
State/province [132] 0 0
Kecskemet
Country [133] 0 0
Hungary
State/province [133] 0 0
Kistarcsa
Country [134] 0 0
Hungary
State/province [134] 0 0
Szeged
Country [135] 0 0
Hungary
State/province [135] 0 0
Szekesfehervar
Country [136] 0 0
Hungary
State/province [136] 0 0
Szolnok
Country [137] 0 0
Hungary
State/province [137] 0 0
Zalaegerszeg
Country [138] 0 0
India
State/province [138] 0 0
Aurangabad
Country [139] 0 0
India
State/province [139] 0 0
Bangalore
Country [140] 0 0
India
State/province [140] 0 0
Belagavi
Country [141] 0 0
India
State/province [141] 0 0
Chennai
Country [142] 0 0
India
State/province [142] 0 0
Jaipur
Country [143] 0 0
India
State/province [143] 0 0
Mumbai
Country [144] 0 0
India
State/province [144] 0 0
Nagpur
Country [145] 0 0
India
State/province [145] 0 0
New Delhi
Country [146] 0 0
India
State/province [146] 0 0
Pune
Country [147] 0 0
Israel
State/province [147] 0 0
Afula
Country [148] 0 0
Israel
State/province [148] 0 0
Ashdod
Country [149] 0 0
Israel
State/province [149] 0 0
Ashkelon
Country [150] 0 0
Israel
State/province [150] 0 0
Beer Sheba
Country [151] 0 0
Israel
State/province [151] 0 0
Beer Yaacov
Country [152] 0 0
Israel
State/province [152] 0 0
Hadera
Country [153] 0 0
Israel
State/province [153] 0 0
Haifa
Country [154] 0 0
Israel
State/province [154] 0 0
Jerusalem
Country [155] 0 0
Israel
State/province [155] 0 0
Kfar-Saba
Country [156] 0 0
Israel
State/province [156] 0 0
Nahariya
Country [157] 0 0
Israel
State/province [157] 0 0
Petah Tikva
Country [158] 0 0
Israel
State/province [158] 0 0
Ramat Gan
Country [159] 0 0
Israel
State/province [159] 0 0
Rehovot
Country [160] 0 0
Israel
State/province [160] 0 0
Safed
Country [161] 0 0
Israel
State/province [161] 0 0
Tel Aviv
Country [162] 0 0
Israel
State/province [162] 0 0
Tiberias
Country [163] 0 0
Japan
State/province [163] 0 0
Aichi, Kasugai
Country [164] 0 0
Japan
State/province [164] 0 0
Aichi, Toyota
Country [165] 0 0
Japan
State/province [165] 0 0
Chiba, Matsudo
Country [166] 0 0
Japan
State/province [166] 0 0
Fukuoka, Fukuoka
Country [167] 0 0
Japan
State/province [167] 0 0
Gifu, Gifu
Country [168] 0 0
Japan
State/province [168] 0 0
Gifu, Ogaki
Country [169] 0 0
Japan
State/province [169] 0 0
Hatsukaichi
Country [170] 0 0
Japan
State/province [170] 0 0
Hiroshima, Hiroshima
Country [171] 0 0
Japan
State/province [171] 0 0
Hyogo, Himeji
Country [172] 0 0
Japan
State/province [172] 0 0
Ibaraki, Kasama
Country [173] 0 0
Japan
State/province [173] 0 0
Ibaraki, Tsuchiura
Country [174] 0 0
Japan
State/province [174] 0 0
Ishikawa, Kanazawa
Country [175] 0 0
Japan
State/province [175] 0 0
Izunokuni
Country [176] 0 0
Japan
State/province [176] 0 0
Kanagawa, Isehara
Country [177] 0 0
Japan
State/province [177] 0 0
Kanagawa, Sagamihara
Country [178] 0 0
Japan
State/province [178] 0 0
Kanagawa, Yokohama
Country [179] 0 0
Japan
State/province [179] 0 0
Kasuga
Country [180] 0 0
Japan
State/province [180] 0 0
Kumamoto, Kumamoto
Country [181] 0 0
Japan
State/province [181] 0 0
Kusatsu
Country [182] 0 0
Japan
State/province [182] 0 0
Miyazaki
Country [183] 0 0
Japan
State/province [183] 0 0
Nagano, Nagano
Country [184] 0 0
Japan
State/province [184] 0 0
Osaka, Osaka
Country [185] 0 0
Japan
State/province [185] 0 0
Takamatsu
Country [186] 0 0
Japan
State/province [186] 0 0
Tokushima
Country [187] 0 0
Japan
State/province [187] 0 0
Tokyo, Chuo-ku
Country [188] 0 0
Japan
State/province [188] 0 0
Urayasu
Country [189] 0 0
Japan
State/province [189] 0 0
Yokohama
Country [190] 0 0
Korea, Republic of
State/province [190] 0 0
Bucheon
Country [191] 0 0
Korea, Republic of
State/province [191] 0 0
Busan
Country [192] 0 0
Korea, Republic of
State/province [192] 0 0
Cheongiu
Country [193] 0 0
Korea, Republic of
State/province [193] 0 0
Daejoen
Country [194] 0 0
Korea, Republic of
State/province [194] 0 0
Gwangju
Country [195] 0 0
Korea, Republic of
State/province [195] 0 0
Seongnam
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
Wonju-si
Country [197] 0 0
Netherlands
State/province [197] 0 0
Alkmaar
Country [198] 0 0
Netherlands
State/province [198] 0 0
Amersfoort
Country [199] 0 0
Netherlands
State/province [199] 0 0
Amsterdam
Country [200] 0 0
Netherlands
State/province [200] 0 0
Arnhem
Country [201] 0 0
Netherlands
State/province [201] 0 0
Breda
Country [202] 0 0
Netherlands
State/province [202] 0 0
Capelle Aan Den Ijssel
Country [203] 0 0
Netherlands
State/province [203] 0 0
Eindhoven
Country [204] 0 0
Netherlands
State/province [204] 0 0
Enschede
Country [205] 0 0
Netherlands
State/province [205] 0 0
Goes
Country [206] 0 0
Netherlands
State/province [206] 0 0
Groningen
Country [207] 0 0
Netherlands
State/province [207] 0 0
Haarlem
Country [208] 0 0
Netherlands
State/province [208] 0 0
Heerlen
Country [209] 0 0
Netherlands
State/province [209] 0 0
Hertogenbosch
Country [210] 0 0
Netherlands
State/province [210] 0 0
Hilversum
Country [211] 0 0
Netherlands
State/province [211] 0 0
Hoorn
Country [212] 0 0
Netherlands
State/province [212] 0 0
Leeuwarden
Country [213] 0 0
Netherlands
State/province [213] 0 0
Leiden
Country [214] 0 0
Netherlands
State/province [214] 0 0
Tiel
Country [215] 0 0
Netherlands
State/province [215] 0 0
Tilburg
Country [216] 0 0
Netherlands
State/province [216] 0 0
Zwolle
Country [217] 0 0
Poland
State/province [217] 0 0
Belchatow
Country [218] 0 0
Poland
State/province [218] 0 0
Bialystok
Country [219] 0 0
Poland
State/province [219] 0 0
Bielsko-Biala
Country [220] 0 0
Poland
State/province [220] 0 0
Chorzow
Country [221] 0 0
Poland
State/province [221] 0 0
Dabrowa Gornicza
Country [222] 0 0
Poland
State/province [222] 0 0
Gdynia
Country [223] 0 0
Poland
State/province [223] 0 0
Katowice
Country [224] 0 0
Poland
State/province [224] 0 0
Kedzierzyn-Kozle
Country [225] 0 0
Poland
State/province [225] 0 0
Krakow
Country [226] 0 0
Poland
State/province [226] 0 0
Nowy Targ
Country [227] 0 0
Poland
State/province [227] 0 0
Ostroleka
Country [228] 0 0
Poland
State/province [228] 0 0
Oswiecim
Country [229] 0 0
Poland
State/province [229] 0 0
Pulawy
Country [230] 0 0
Poland
State/province [230] 0 0
Sztum
Country [231] 0 0
Poland
State/province [231] 0 0
Tychy
Country [232] 0 0
Poland
State/province [232] 0 0
Walbrzych
Country [233] 0 0
Poland
State/province [233] 0 0
Warsaw
Country [234] 0 0
Poland
State/province [234] 0 0
Wroclaw
Country [235] 0 0
Romania
State/province [235] 0 0
Baia Mare
Country [236] 0 0
Romania
State/province [236] 0 0
Balotesti
Country [237] 0 0
Romania
State/province [237] 0 0
Braila
Country [238] 0 0
Romania
State/province [238] 0 0
Brasov
Country [239] 0 0
Romania
State/province [239] 0 0
Bucharest
Country [240] 0 0
Romania
State/province [240] 0 0
Cluj Napoca
Country [241] 0 0
Romania
State/province [241] 0 0
Craiova
Country [242] 0 0
Romania
State/province [242] 0 0
Iasi
Country [243] 0 0
Romania
State/province [243] 0 0
Oradea
Country [244] 0 0
Romania
State/province [244] 0 0
Pitesti
Country [245] 0 0
Romania
State/province [245] 0 0
Sibiu
Country [246] 0 0
Romania
State/province [246] 0 0
Targu-Mures
Country [247] 0 0
Romania
State/province [247] 0 0
Timisoara
Country [248] 0 0
Russian Federation
State/province [248] 0 0
Arkhangelsk
Country [249] 0 0
Russian Federation
State/province [249] 0 0
Kirov
Country [250] 0 0
Russian Federation
State/province [250] 0 0
Krasnodar
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Moscow
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Nizhniy Novgorod
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Penza
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Petrozavodsk
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Ryazan
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Samara
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Saratov
Country [258] 0 0
Russian Federation
State/province [258] 0 0
St. Petersburg
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Syktyvkar
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Tver
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Tyumen
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Volgograd
Country [263] 0 0
Serbia
State/province [263] 0 0
Belgrade
Country [264] 0 0
Serbia
State/province [264] 0 0
Kragujevac
Country [265] 0 0
Serbia
State/province [265] 0 0
Leskovac
Country [266] 0 0
Serbia
State/province [266] 0 0
Niska Banja
Country [267] 0 0
Serbia
State/province [267] 0 0
Nis
Country [268] 0 0
Serbia
State/province [268] 0 0
Pancevo
Country [269] 0 0
Serbia
State/province [269] 0 0
Sremska Kamenica
Country [270] 0 0
Serbia
State/province [270] 0 0
Sremska Mitrovica
Country [271] 0 0
Serbia
State/province [271] 0 0
Subotica
Country [272] 0 0
Serbia
State/province [272] 0 0
Uzice
Country [273] 0 0
Serbia
State/province [273] 0 0
Zajecar
Country [274] 0 0
Serbia
State/province [274] 0 0
Zrenjanin
Country [275] 0 0
Spain
State/province [275] 0 0
Badalona
Country [276] 0 0
Spain
State/province [276] 0 0
Barcelona
Country [277] 0 0
Spain
State/province [277] 0 0
Madrid
Country [278] 0 0
Spain
State/province [278] 0 0
Tarragona
Country [279] 0 0
Spain
State/province [279] 0 0
Vigo
Country [280] 0 0
Ukraine
State/province [280] 0 0
Cherkasy
Country [281] 0 0
Ukraine
State/province [281] 0 0
Dnepropetrovsk
Country [282] 0 0
Ukraine
State/province [282] 0 0
Ivano-Frankivsk
Country [283] 0 0
Ukraine
State/province [283] 0 0
Kharkiv
Country [284] 0 0
Ukraine
State/province [284] 0 0
Khmelnytskyi
Country [285] 0 0
Ukraine
State/province [285] 0 0
Kiev
Country [286] 0 0
Ukraine
State/province [286] 0 0
Lutsk
Country [287] 0 0
Ukraine
State/province [287] 0 0
Lviv
Country [288] 0 0
Ukraine
State/province [288] 0 0
Odesa
Country [289] 0 0
Ukraine
State/province [289] 0 0
Ternopil
Country [290] 0 0
Ukraine
State/province [290] 0 0
Uzhgorod
Country [291] 0 0
Ukraine
State/province [291] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.

People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.

Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.
Trial website
https://clinicaltrials.gov/study/NCT04509674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04509674