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)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified November 2024 by Boehringer Ingelheim
Sponsor
Boehringer Ingelheim
Information Provided by (Responsible Party)
Boehringer Ingelheim
Clinicaltrials.gov Identifier
NCT04509674
Other Study ID Numbers:
1245-0202
First Submitted
August 9, 2020
First Posted
August 11, 2020
Results First Posted
November 3, 2024
Last Update Posted
January 6, 2025
Last Verified
November 2024

ClinicalTrials.gov processed this data on December 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Myocardial Infarction
Drug: EmpagliflozinDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment6522 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEMPACT-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
Study Start DateDecember 15, 2020
Actual Primary Completion DateNovember 4, 2023
Actual Study Completion DateNovember 4, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Empagliflozin 10 mg
Drug: Empagliflozin
Empagliflozin
Placebo
Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures
  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).
Secondary Outcome Measures
  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.
  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.
  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.
  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.
  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).

Eligibility Criteria

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

Contacts and Locations

Sponsors and CollaboratorsBoehringer Ingelheim
Locations
Advanced Cardiovascular LLC | Alexander City Alabama, United States, 35010Grandview Medical Center | Birmingham Alabama, United States, 35243Heart Center Research, LLC | Huntsville Alabama, United States, 35801Mercy Gilbert Medical Center | Gilbert Arizona, United States, 85297Arkansas Cardiology, PA | Little Rock Arkansas, United States, 72205Comprehensive Cardiovascular Medical Group | Bakersfield California, United States, 93309Valley Clinical Trials, Inc. | Covina California, United States, 91723Cardiovascular Innovation and Research Center | Long Beach California, United States, 90813University of California Los Angeles | Los Angeles California, United States, 90095InvivoCure | Mission Hills California, United States, 91346Valley Clinical Trials, Inc. | Northridge California, United States, 91325Valley Clinical Trials, Inc. | Pasadena California, United States, 91105Kaiser Permanente | San Diego California, United States, 92123San Diego Cardiac Center | San Diego California, United States, 92123The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance California, United States, 90502Interventional Cardiology Medical Group | West Hills California, United States, 91307George Washington University Medical Faculty Associates | Washington D.C. District of Columbia, United States, 20037Clearwater Cardiovascular Consultants | Clearwater Florida, United States, 33756Integrative Research Associates | Fort Lauderdale Florida, United States, 33312University of Florida Health Jacksonville | Jacksonville Florida, United States, 32209Cardiology Partners Clinical Research Institute | Palm Beach Gardens Florida, United States, 33410Charlotte Heart Group Research Center | Port Charlotte Florida, United States, 33952Grady Memorial Hospital | Atlanta Georgia, United States, 30303Cardiovascular Consultants of South Georgia, LLC | Thomasville Georgia, United States, 31792Atlanta Heart Specialists, LLC | Tucker Georgia, United States, 30084Advanced Heart Care, LLC, Medicoricum, LLC | Fairview Heights Illinois, United States, 62208Midwest Cardiovascular Research and Education Foundation | Elkhart Indiana, United States, 46514Cardiovascular Research of Northwest Indiana, LLC | Munster Indiana, United States, 46321Reid Physician Associates | Richmond Indiana, United States, 47374Midwest Heart and Vascular Specialists | Overland Park Kansas, United States, 66211University of Kentucky Medical Center | Lexington Kentucky, United States, 40536-0200University of Louisville | Louisville Kentucky, United States, 40202Eastern Maine Medical Center | Bangor Maine, United States, 04401Cardiovascular Specialists of Central Maryland | Columbia Maryland, United States, 21044Shady Grove Adventist Hospital | Rockville Maryland, United States, 20850Healthy Heart Cardiology | Grand Rapids Michigan, United States, 49546Western Michigan University | Kalamazoo Michigan, United States, 49009Mid Michigan Medical Center | Midland Michigan, United States, 48670Michigan Heart, PC | Ypsilanti Michigan, United States, 48197Minneapolis Heart Institute Foundation | Minneapolis Minnesota, United States, 55407Cardiology Associates Research, LLC | Tupelo Mississippi, United States, 38801Missouri Cardiovascular Specialists, LLP | Columbia Missouri, United States, 65201University of Missouri Health System | Columbia Missouri, United States, 65212North Kansas City Hospital | North Kansas City Missouri, United States, 64116Gateway Cardiology, PC | St Louis Missouri, United States, 63128St. Louis Heart and Vascular, P.C. | St Louis Missouri, United States, 63136Holy Name Medical Center | Hackensack New Jersey, United States, 07601AtlantiCare | Pomona New Jersey, United States, 08240The Heart House | Vineland New Jersey, United States, 08360SJH Cardiology Associates | Liverpool New York, United States, 13088Stony Brook University Hospital | Stony Brook New York, United States, 11794Asheville Cardiology Associates | Asheville North Carolina, United States, 28803The University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27517Duke University Medical Center | Durham North Carolina, United States, 27705Moses H. Cone Memorial Hospital | Greensboro North Carolina, United States, 27401Medication Management, LLC | Greensboro North Carolina, United States, 27405North Carolina Heart and Vascular | Raleigh North Carolina, United States, 27607Trinity Health Center Medical Arts | Minot North Dakota, United States, 58701Aultman Hospital | Canton Ohio, United States, 44710Cincinnati VA Medical Center | Cincinnati Ohio, United States, 45220Kettering Medical Center | Kettering Ohio, United States, 45429Oklahoma Heart Hospital Research Foundation, Incorporated | Oklahoma City Oklahoma, United States, 73120South Oklahoma Heart Research Group | Oklahoma City Oklahoma, United States, 73135Capital Area Research, LLC | Camp Hill Pennsylvania, United States, 17011Penn Presbyterian Medical Center | Philadelphia Pennsylvania, United States, 19104Guthrie Medical Group PC | Sayre Pennsylvania, United States, 18840Upstate Cardiology, PA | Greenville South Carolina, United States, 29607Carolina Heart Specialists, LLC | Lancaster South Carolina, United States, 29720Monument Health | Rapid City South Dakota, United States, 57701Centennial Heart Cardiovascular Consultants, LLC | Nashville Tennessee, United States, 37203Parkway Cardiology Associates | Oak Ridge Tennessee, United States, 37830Cardiovascular Research of Knoxville | Powell Tennessee, United States, 37849Texas Health Presbyterian Hospital Allen | Allen Texas, United States, 75013Amarillo Heart Clinical Research Institute, Incorporated | Amarillo Texas, United States, 79106Pharmatex Research | Amarillo Texas, United States, 79109Dallas VA Medical Center | Dallas Texas, United States, 75216Baylor Scott and White Health | Plano Texas, United States, 75093South Texas Cardiovascular Consultants | San Antonio Texas, United States, 78201Revival Research Institute, LLC. | Sherman Texas, United States, 75092Cardiovascular Associates of East Texas, PA | Tyler Texas, United States, 75701Carient Heart and Vascular | Manassas Virginia, United States, 20109Riverside Regional Medical Center | Newport News Virginia, United States, 23601Tidewater Physicians Multispecialty Group | Newport News Virginia, United States, 23606Sentara Hospitals | Norfolk Virginia, United States, 23507Roanoke Heart Institute PLC | Roanoke Virginia, United States, 24014Instituto Cardiovascular de Buenos Aires | Belgrano , Argentina, C1428ARTFundacion Sanatorio Güemes | Ciudad Autonoma Buenos Aires , Argentina, C1180 AAXCentro de Investigacion Clinica Coronel Suarez | Coronel Suárez , Argentina, B7540GHDInstituto de Cardiologia de Corrientes | Corrientes , Argentina, 3400Hospital Italiano de Córdoba | Córdoba , Argentina, X5000Sanatorio Allende | Córdoba , Argentina, X5000Centro Medico Luquez | Córdoba , Argentina, X5006CBIHospital Privado Centro Medico de Cordoba | Córdoba , Argentina, X5016KEHClinica Privada del Prado | Córdoba , Argentina, X5020AAAFundación Favaloro para la Docencia e Investigación Medica | Montserrat , Argentina, C1093AASSanatorio Modelo de Quilmes | Quilmes , Argentina, B1878GEGInstituto Cardiovascular de Rosario | Rosario , Argentina, S2000Sanatorio Delta | Rosario , Argentina, S2000Sanatorio Parque | Rosario , Argentina, S2000Corporacion Medica de Gral. San Martin S.A. | San Martin , Argentina, B1650CSPCentro Privado de Cardiologia | San Miguel de Tucumán , Argentina, 4000Clinica U.O.M. | San Nicolás , Argentina, 2900Sanatorio Diagnóstico | Santa Fe , Argentina, 3081Hospital "Dr. José Maria Cullen" | Santa Fe , Argentina, S3000EOZClinica Privada Fusavim SRL | Villa María , Argentina, 5900Concord Repatriation General Hospital | Concord New South Wales, Australia, 2139South Western Sydney Local Health District | Liverpool New South Wales, Australia, 2170Royal North Shore Hospital | St Leonards New South Wales, Australia, 2065Westmead Hospital | Westmead New South Wales, Australia, 2145The Prince Charles Hospital | Chermside Queensland, Australia, 4032Royal Brisbane and Women's Hospital | Herston Queensland, Australia, 4029Gold Coast University Hospital | Southport Queensland, Australia, 4215Alfred Hospital | Melbourne Victoria, Australia, 3004JMF Clinica Do Coracao LTDA | Aracaju - SE , Brazil, 49055-530Hospital Santa Isabel | Balneário Camboriú , Brazil, 88331-085Hospital Madre Teresa | Belo Horizonte , Brazil, 30441-070Hospital do Coracao do Brasil | Brasília , Brazil, 70390 700Hospital Angelina Caron | Campina Grande do Sul , Brazil, 83430-000Centro Especializado em Cardiol Loema Instituto de Pesq Clin | Campinas , Brazil, 13010-001IPECC - Instituto de Pesquisa Clínica de Campinas | Campinas , Brazil, 13060-080Hospital de Messejana Dr. Carlos Alberto Studart Gomes | Fortaleza , Brazil, 60840-285HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás | Goiânia , Brazil, 74605-020Hospital Regional Hans Dieter Schmidt | Joinville , Brazil, 89227-680Santa Casa de Misericórdia de Marília | Marília , Brazil, 17515-000Hospital São Vicente de Paulo | Passo Fundo , Brazil, 99010-080Hospital Sao Lucas da PUCRS | Porto Alegre , Brazil, 01046 010Instituto de Cardiologia Rio Grande do Sul | Porto Alegre , Brazil, 90620-001Hospital Nossa Senhora da Conceição | Porto Alegre , Brazil, 91350-200Hospital Agamenon Magalhaes | Recife , Brazil, 52051-380Fundacao de apoio ao ensino e assitencia HCFMRP | Ribeirão Preto , Brazil, 14051-140Hospital Copa D'or | Rio de Janeiro , Brazil, 22031-011Instituto de Ensino E Pesquisa Do Hospital Da Bahia | Salvador , Brazil, 41810-011CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo , Brazil, 09715-090Hospital de Base - Fac Med de Sao Jose do Rio Preto | São José do Rio Preto , Brazil, 15090-000Hospital Samaritano | São Paulo , Brazil, 01333-030Hospital Sao Luiz Jabaquara | São Paulo , Brazil, 04321-120Hospital Sao Luiz Morumbi | São Paulo , Brazil, 04544-000Hospital das Clínicas de Sao Paulo - INCOR | São Paulo , Brazil, 05403-000Santa Casa de Votuporanga | Votuporanga , Brazil, 15500-003Multiprofile Hospital For Active Treatment Pulse AD | Blagoevgrad , Bulgaria, 2700Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD | Gabrovo , Bulgaria, 5300Multiprofile Hospital for Active Treatment AD Haskovo | Haskovo , Bulgaria, 6304Multiprofile Hospital For Active Treatment - Pazardzhik AD | Pazardzhik , Bulgaria, 4400Specialized Hospital for Active Treatment Sv. Georgi - Pernik | Pernik , Bulgaria, 2300Medical Center Medconsult Pleven LTD | Pleven , Bulgaria, 5800Multiprofile Hospital for Active Treatment Heart and Brain EAD | Pleven , Bulgaria, 5804SHAT in Cardiology EAD, Pleven | Pleven , Bulgaria, 5804Hospital MHAT Plovdiv, AD | Plovdiv , Bulgaria, 4003National Heart Hospital, Sofia | Sofia , Bulgaria, 1309City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia | Sofia , Bulgaria, 1407University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD | Sofia , Bulgaria, 1431UMHAT "Tsaritsa Yoannalsul" | Sofia , Bulgaria, 1527Medical Military Academy MHAT Sofia | Sofia , Bulgaria, 1606Multiprofile Hospital MHATEM 'Pirogov', Sofia | Sofia , Bulgaria, 1606MHAT Sv.Anna, Clinic of Internal Diseases, Sofia | Sofia , Bulgaria, 1750Hospital Trakia Park | Stara Zagora , Bulgaria, 6004Heritage Medical Research Clinic | Calgary Alberta, Canada, T2N 4Z6Royal Alexandra Hospital | Edmonton Alberta, Canada, T5H 3V9University of Alberta Hospital (University of Alberta) | Edmonton Alberta, Canada, T6G 2B7Royal Inland Hospital | Kamloops British Columbia, Canada, V2C 2T1Surrey Memorial Hospital | Surrey British Columbia, Canada, V3V 0C6Vancouver General Hospital | Vancouver British Columbia, Canada, V5Z 1M9Victoria Heart Institute Foundation | Victoria British Columbia, Canada, V8R 1B2St. Boniface Hospital | Winnipeg Manitoba, Canada, R2H 2A6GA Research Associates Ltd. | Moncton New Brunswick, Canada, E1G 1A7QEII Health Sciences Centre | Halifax Nova Scotia, Canada, B3H 3A7William Osler Health Centre | Brampton Ontario, Canada, L6R 3J7Queen's University | Kingston Ontario, Canada, K7L 2V7One Heart Care Ventures | Mississauga Ontario, Canada, L4Y 1M3Southlake Regional Health Centre | Newmarket Ontario, Canada, L3Y 2P7Peterborough Regional Health Centre | Peterborough Ontario, Canada, K9J 7C6Heart Health Institute | Scarborough Village Ontario, Canada, M1B 4Z8Women's College Hospital | Toronto Ontario, Canada, M5S 1B2Montreal Heart Institute | Montreal Quebec, Canada, H1T 1C8Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal Quebec, Canada, H2X 0A9Montreal General Hospital - McGill University Health Centre | Montreal Quebec, Canada, H3G 1A4McGill University Health Centre (MUHC) | Montreal Quebec, Canada, H4A 3J1IUCPQ (Laval University) | Sainte-Foy Quebec, Canada, G1V 4G5CIUSSS de l Estrie-CHUS | Sherbrooke Quebec, Canada, J1H 5N4CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur | Terrebonne (Lachenaie) Quebec, Canada, J6V 2H2CIUSSS de la Mauricie-et-du-Centre-du-Quebec | Trois-Rivières Quebec, Canada, G8Z 3R9Prairie Vascular Research Inc. | Regina Saskatchewan, Canada, S4P 0W5Oakville Trafalgar Memorial Hospital | Oakville , Canada, L6M 0L8Beijing Chao-Yang Hospital | Beijing , China, 100020Chinese PLA General Hospital | Beijing , China, 100022China-Japan Friendship Hospital | Beijing , China, 100029Peking University First Hospital | Beijing , China, 100034Beijing Luhe Hospital Capital Medical University | Beijing , China, 101100Changsha Central Hospital | Changsha , China, 410007Xiangya Hospital, Central South University | Changsha , China, 410008Guangdong Provincial People's Hospital | Guangzhou , China, 510100The First Affiliated Hospital of Harbin Medical University | Haerbin , China, 150001Hainan General Hospital | Haikou , China, 570311Shulan(Hanghzhou) Hospital | Hangzhou , China, 310004Zhejiang Hospital | Hangzhou , China, 310013Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou , China, 310016The Second Affiliated Hospital of Lanzhou Medical University | Lanzhou , China, 730030Nanjing Drum Tower Hospital | Nanjing , China, 210008Zhongshan Hospital Affiliated to Fudan University | Shanghai , China, 200032People's Hospital of Liaoning Province | Shenyang , China, 110016Peking University Shenzhen Hospital | Shenzhen , China, 518036Renmin Hospital of Wuhan University | Wuhan , China, 430060Aalborg Universitetsshospital | Aalborg , Denmark, 9000Aarhus University Hospital | Aarhus N , Denmark, 8200Rigshospitalet | Copenhagen , Denmark, 2100Frederiksberg Hospital | Frederiksberg , Denmark, 2000Herlev and Gentofte Hospital | Herlev , Denmark, 2730Slagelse Sygehus | Slagelse , Denmark, 4200HOP Sud Francilien | Corbeil-Essonnes , France, 91106HOP CHU de Grenoble | Grenoble , France, 38043CHRU Lille | Lille , France, 59037Hospital de Saint Joseph et Saint Luc | Lyon , France, 69007HOP Bichat | Paris , France, 75018CHU Rouen | Rouen , France, 76031HOP Trousseau | Tours , France, 37044HOP Brabois | Vandœuvre-lès-Nancy , France, 54511SLK-Kliniken Heilbronn GmbH | Bad Friedrichshall , Germany, 74177Kerckhoff-Klinik, Bad Nauheim | Bad Nauheim , Germany, 61231Charité - Universitätsmedizin Berlin | Berlin , Germany, 12203Universitätsklinikum Bonn AöR | Bonn , Germany, 53127Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser | Bremen , Germany, 28277Klinikum Coburg gGmbH | Coburg , Germany, 96450St. Johannes Hospital Dortmund | Dortmund , Germany, 44137Städtisches Klinikum Dresden | Dresden , Germany, 01067Universitätsklinikum Frankfurt | Frankfurt am Main , Germany, 60596Klinikum Frankfurt Höchst GmbH | Frankfurt am Main , Germany, 65929Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH | Freiburg I. Breisgau , Germany, 79106Asklepios Kliniken GmbH & Co. KGaA | Hamburg , Germany, 22307Medizinische Hochschule Hannover | Hanover , Germany, 30625Ambulantes Herzzentrum Kassel | Kassel , Germany, 34121Universitätsklinikum Leipzig | Leipzig , Germany, 04103Katholisches Klinikum Mainz | Mainz , Germany, 55131Clemenshospital | Münster , Germany, 48153Kardiologische Praxis Papenburg | Papenburg , Germany, 26871Universitätsklinikum Regensburg | Regensburg , Germany, 93053Lausmed Kft. Outpatient Unit of Internal Medicine | Baja , Hungary, 6500Buda Hospital of the Hospitaller Order of Saint John of God | Budapest , Hungary, 1023Semmelweis University | Budapest , Hungary, 1085St. Imre Hospital, Budapest | Budapest , Hungary, 1115Semmelweis University | Budapest , Hungary, 1122Magyar Honvedseg Egeszsegugyi Kozpont | Budapest , Hungary, 1134Jahn Ferenc Del-Pest Hospital | Budapest , Hungary, 1204University Debrecen Hospital | Debrecen , Hungary, 4032Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako | Hódmezővásárhely , Hungary, 6800Somogy County Kaposi Mor Teaching Hospital | Kaposvár , Hungary, 7400Bacs-Kiskun Megyei Onkormanyzat Hospital | Kecskemét , Hungary, 6000Pest Megyei Flor Ferenc Hospital | Kistarcsa , Hungary, 2143University of Szeged | Szeged , Hungary, 6720Fejer County Saint George University Teaching Hospital | Székesfehérvár , Hungary, 8000Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet | Szolnok , Hungary, 5000Zala County Hospital, Zalaegerszeg | Zalaegerszeg , Hungary, 8900Kamalnayan Bajaj Hospital | Aurangabad , India, 431 010Sri Jayadeva Institute of Cardiovascular Sciences & Research | Bangalore , India, 560069Narayana Institute of Cardiac Sciences | Bangalore , India, 560099KLES Dr.Prabhakar Kore Hospital and Medical Research Centre | Belagavi , India, 590010Madras Medical Mission, | Chennai , India, 600037Eternal Heart Care Centre & Research Institute Pvt. Ltd. | Jaipur , India, 302017KEM Hospital and Seth G S Medical College | Mumbai , India, 400012Sion Hospital (Lokmanya Tilak Municipal Hospital) | Mumbai , India, 400022Government Medical College & Hospital | Nagpur , India, 440009GB Pant Institute of Post Graduate Medical Education and Research | New Delhi , India, 110002Max Superspeciality Hospital | New Delhi , India, 110017Sir Gangaram Hospital | New Delhi , India, 110060Sahyadri Speciality Hospital | Pune , India, 411004Haemek Medical Center | Afula , Israel, 18101Assuta Medical Center | Ashdod , Israel, 77000Barzilai Medical Center | Ashkelon , Israel, 78278Assaf Harofe Medical Center | Beer Yaacov , Israel, 70300Soroka Univ. Medical Center | Beersheba , Israel, 8410101Hillel Yaffe Medical Center, Hadera | Hadera , Israel, 38100Rambam Medical Center | Haifa , Israel, 31096Bnei Zion Medical Center, Haifa | Haifa , Israel, 33394Lady Davis Carmel Medical Center | Haifa , Israel, 34362Hadassah Medical Center, Ein-Karem | Jerusalem , Israel, 91000Shaare Zedek Medical Center, Jerusalem 91031 | Jerusalem , Israel, 9103102Hadassah Medical Center, Ein-Karem | Jerusalem , Israel, 91120Meir Medical Center | Kfar Saba , Israel, 44281West.Galilee Med.Cent.Naharia | Nahariya , Israel, 22100Rabin Medical Center Beilinson | Petah Tikva , Israel, 49100Rabin Medical Center Beilinson | Petah Tikva , Israel, 4941492The Chaim Sheba Medical Center Tel HaShomer | Ramat Gan , Israel, 52621Kaplan Medical Center | Rehovot , Israel, 76100Ziv Medical Center | Safed , Israel, 13100Sourasky Medical Center | Tel Aviv , Israel, 64239Baruch Padeh Medical Center | Tiberias , Israel, 15208Kasugai Municipal Hospital | Aichi, Kasugai , Japan, 486-8510Toyota Memorial Hospital | Aichi, Toyota , Japan, 471-8513Chibanishi General Hospital | Chiba, Matsudo , Japan, 270-2251Seikeikai New Tokyo Heart Clinic | Chiba, Matsudo , Japan, 271-0077Saiseikai Fukuoka General Hospital | Fukuoka, Fukuoka , Japan, 810-0001Gifu Prefectural General Medical Center | Gifu, Gifu , Japan, 500-8717Ogaki Municipal Hospital | Gifu, Ogaki , Japan, 503-8502Hiroshima General Hospital | Hatsukaichi , Japan, 738-8503Hiroshima Prefectural Hospital | Hiroshima, Hiroshima , Japan, 734-8530Hyogo Brain and Heart Center | Hyogo, Himeji , Japan, 670-0981Ibaraki Prefectural Central Hospital | Ibaraki, Kasama , Japan, 309-1793Tsuchiura Kyodo General Hospital | Ibaraki, Tsuchiura , Japan, 300-0028Ishikawa Prefectural Central Hospital | Ishikawa, Kanazawa , Japan, 920-8530Juntendo University Shizuoka Hospital | Izunokuni , Japan, 410-2295Tokai University Hospital | Kanagawa, Isehara , Japan, 259-1193Sagamihara Kyodo Hospital | Kanagawa, Sagamihara , Japan, 252-5188Yokohama City University Medical Center | Kanagawa, Yokohama , Japan, 232-0024Fukuoka Tokushukai Hospital | Kasuga , Japan, 816-0864Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto , Japan, 861-4193Japanese Red Cross Kumamoto Hospital | Kumamoto, Kumamoto , Japan, 861-8520Kusatsu General Hospital | Kusatsu , Japan, 525-8585Miyazaki Medical Association Hospital | Miyazaki , Japan, 880-2102Nagano Chuo Hospital | Nagano, Nagano , Japan, 380-0814Osaka Police Hospital | Osaka, Osaka , Japan, 543-0035Kagawa Prefectural Central Hospital | Takamatsu , Japan, 760-8557Tokushima Prefectural Central Hospital | Tokushima , Japan, 770-0042St. Luke's International Hospital | Tokyo, Chuo-ku , Japan, 104-8560Tokyo Bay Urayasu Ichikawa Medical Center | Urayasu , Japan, 279-0001Showa University Fujigaoka Hospital | Yokohama , Japan, 227-8501Jeroen Bosch Ziekenhuis-Hertogenbosch | 's-Hertogenbosch , Netherlands, 5223 GZNoordwest Ziekenhuisgroep | Alkmaar , Netherlands, 1815 JDMeander Medisch Centrum | Amersfoort , Netherlands, 3813 TZAmsterdam UMC Locatie VUMC | Amsterdam , Netherlands, 1081HVOnze Lieve Vrouwe Gasthuis | Amsterdam , Netherlands, 1091 HARijnstate Hospital | Arnhem , Netherlands, 6815 ADAmphia Ziekenhuis | Breda , Netherlands, 4819 EVIJsselland Ziekenhuis | Capelle aan den IJssel , Netherlands, 2906 ZCCatharina Ziekenhuis | Eindhoven , Netherlands, 5623 EJMedisch Spectrum Twente | Enschede , Netherlands, 7513 ERAdmiraal de Ruyter Ziekenhuis | Goes , Netherlands, 4462 RAUniversitair Medisch Centrum Groningen | Groningen , Netherlands, 9713 GZSpaarne Ziekenhuis | Haarlem , Netherlands, 2035 RCZuyderland Medisch Centrum | Heerlen , Netherlands, 6419 PCTergooi Ziekenhuis | Hilversum , Netherlands, 1213 XZVasculair Onderzoek Centrum | Hoorn , Netherlands, 1624 NPMedisch Centrum Leeuwarden | Leeuwarden , Netherlands, 8934 ADLeids Universitair Medisch Centrum (LUMC) | Leiden , Netherlands, 2300 RCAlrijne Ziekenhuis | Leiden , Netherlands, 2334 CKZiekenhuis Rivierenland | Tiel , Netherlands, 4002 WPTweesteden Ziekenhuis, locatie Tilburg | Tilburg , Netherlands, 5042 ADIsala Zwolle | Zwolle , Netherlands, 8025 ABAmerican Heart of Poland | Bełchatów , Poland, 97-400Univ. Clinic Hosp, Bialystok | Bialystok , Poland, 15-276American Heart of Poland Sp. z o.o. | Bielsko-Biala , Poland, 43-316American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre | Chorzów , Poland, 32-500American Heart of Poland Sp. z o.o. | Dąbrowa Górnicza , Poland, 41-300NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog. | Gdynia , Poland, 81-423Silesian Medical University in Katowice | Katowice , Poland, 40-635American Heart of Poland Sp. z o.o. | Kędzierzyn-Koźle , Poland, 47-200University Hospital in Krakow | Krakow , Poland, 30-688The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow | Krakow , Poland, 31-202Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag | Nowy Targ , Poland, 34-400Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego | Ostrołęka , Poland, 07-410Medicome Limited Liability Company | Oświęcim , Poland, 32-600Independent Public Healthcare, Dept. of Cardiology, Pulawy | Puławy , Poland, 24-100American Heart of Poland Sp. z o.o. | Sztum , Poland, 82-400American Heart of Poland Sp. z o.o. | Tychy , Poland, 43-100Central Hospital of Medical Academy, Warsaw | Warsaw , Poland, 02-097Instytut Kardiologii, Warszawa | Warsaw , Poland, 04-628Dr Alfred Sokołowski Specialist Hospital | Wałbrzych , Poland, 58-309Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw | Wroclaw , Poland, 50-5564. Military Clinical Hospital with Polyclinic SP ZOZ | Wroclaw , Poland, 50-981Emergency Clinical County Hospital, Baia Mare | Baia Mare , Romania, 430031Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu" | Baloteşti , Romania, 077016Spitalul Clinic Judetean de Urgenta Brasov | Brasov , Romania, 500326Spitalul Judetean de Urgenta Braila | Brăila , Romania, 810325Military Central Clinical Emergency Hospital | Bucharest , Romania, 010825Elias Emergency Hospital, Bucharest | Bucharest , Romania, 011461Prof.C.C.Iliescu Hospital, National Institute of Cardiology | Bucharest , Romania, 022328Emergency Clinical Hospital "Bagdasar-Arseni" | Bucharest , Romania, 041915Emergency University Hospital, Bucharest | Bucharest , Romania, 050098Heart Institute "Niculae Stancioiu", Cluj Napoca | Cluj-Napoca , Romania, 400001Clincal Reabilitation Hospital, Cluj Napoca | Cluj-Napoca , Romania, 400347Spitalul Clinic Judetean, Craiova | Craiova , Romania, 200642Cardiovascular Diseases Institute "Prof. Georgescu", Iasi | Iași , Romania, 700503SC Cardiomed SRL, Iasi | Iași , Romania, 700732SC Endodigest SRL | Oradea , Romania, 410151Sal Med Srl | Piteşti , Romania, 110424Emergency County Clinical Hospital, Sibiu | Sibiu , Romania, 550245Centrul Medical Cardiomed | Târgu Mureş , Romania, 540124Country Clinical Emergency Hospital, Targu-Mures | Târgu Mureş , Romania, 540136Cardiology and Cardiovascular Rehabilitation Clinic | Timișoara , Romania, 300310First City Clinical Hospital named after E. E. Volosevich | Arkhangelsk , Russia, 163001Regional Clinical Hospital, Kirov | Kirov , Russia, 610014Regional Clinical Hospital No.1 named after Professor. S.V. Ochapovskiy | Krasnodar , Russia, 350086State Healthcare Institution Clinical Hosp. No. 51, Moscow | Moscow , Russia, 121309Reg.Clin.Hosp.n.a.Semashko | Nizhny Novgorod , Russia, 603126Penza Regional Clinical Hospital named after N.N.Burdenko | Penza , Russia, 440026Republic Kareliya Republican Hosp. named after V.A. Baranov | Petrozavodsk , Russia, 185019GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan | Ryazan , Russia, 390039Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine | Saint Petersburg , Russia, 192242Medical Academy named after I. Mechnikov, St. Petersburg | Saint Petersburg , Russia, 195067Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept. | Samara , Russia, 443070Saratov State Med.Univ.n.a.Razumovskogo | Saratov , Russia, 410012Saratov Regional Cardiac Center | Saratov , Russia, 410039Komi Republican Cardiological Dispensary | Syktyvkar , Russia, 167981Regional clinical hospital, Tver | Tver' , Russia, 170036Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia | Tyumen , Russia, 625026State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr | Volgograd , Russia, 400062Institute for Cardiovascular diseases Dedinje | Belgrade , Serbia, 11000University Clinical Center of Serbia | Belgrade , Serbia, 11000Clinical Hospital Center Dr. Dragisa Misovic | Belgrade , Serbia, 11040Clinical Medical Center Zvezdara, Belgrade | Belgrade , Serbia, 11050Institute of Cardiovascular Diseases | Kamenitz , Serbia, 21204University Clinical Center of Kragujevac | Kragujevac , Serbia, 34000General Hospital Leskovac | Leskovac , Serbia, 16000University Clinical Center Nis | Niš , Serbia, 18000Institute for Treatment and Rehabilitation, Niska Banja | Niška Banja , Serbia, 18205General Hospital Pancevo | Pančevo , Serbia, 26101General Hospital Sremska Mitrovica | Sremska Mitrovica , Serbia, 22000General Hospital Subotica, Internal Medicine | Subotica , Serbia, 24107Health Center Uzice | Užice , Serbia, 31000Health Centre Zajecar | Zaječar , Serbia, 19000General Hospital - Djordje Joanovic | Zrenjanin , Serbia, 23101Bucheon Sejong Hospital | Bucheon-si , South Korea, 14754Pusan National Univ. Hosp | Busan , South Korea, 49241Chungbuk National University Hospital | Cheongiu , South Korea, 28644Chungnam National University Hospital | Daejoen , South Korea, 35015Chonnam National University Hospital | Gwangju , South Korea, 61469Seoul National University Bundang Hospital | Seongnam , South Korea, 13620Yonsei University Wonju Severance Christian Hospital | Wonju-si, Gangwon State , South Korea, 26426Hospital Germans Trias i Pujol | Badalona , Spain, 08916University Hospital of Bellvitge | Barcelona , Spain, 08907Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Universitari Joan XXIII | Tarragona , Spain, 43005Complejo Hospitalario Universitario de Vigo | Vigo , Spain, 36213Cherkasy Regional Cardiological Center | Cherkasy , Ukraine, 18009City Joint Emergency Hospital, Dnepropetrovsk | Dnipro , Ukraine, 49006Ivano-Frankivsk City Central Clinical Hospital | Ivano-Frankivsk , Ukraine, 76005Clinical Treatment and Diagnostic Center of the Limited Liability Company "SIMEDGROUP" | Ivano-Frankivsk , Ukraine, 76008L.T. Malaya Institute of Therapy AMS of Ukraine | Kharkiv , Ukraine, 61039Reg.Clin.Hosp.Non-Commercial Enterprise | Kharkiv , Ukraine, 61058CI of Healthcare Kharkiv CCH #8, Kharkiv | Kharkiv , Ukraine, 61176Khmelnytskyi Regional Hospital | Khmelnytskyi , Ukraine, 29007Kiev City Clinical Hospital No. 5 | Kiev , Ukraine, 03115SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv | Kiev , Ukraine, 03680City Clinical Hospital No. 1, Kiev | Kiev , Ukraine, 2091Kiev Emergency Care Hospital | Kiev , Ukraine, 2166Lutsk City Clinical Hospital | Lutsk , Ukraine, 43024Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital" | Lviv , Ukraine, 79015Odesa Regional Clinical Hospital | Odesa , Ukraine, 65025Regional Clinical Hospital, Ternopil | Ternopil , Ukraine, 46001Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Center of Cardiology and Cardiac Surgery" of Zakarpattia Regional Council | Uzhhorod , Ukraine, 88000Zhytomyr Regional Clinical Hospital, Dept. Endocrinology | Zhytomyr , Ukraine, 10002
Study Documents (Full Text)
Documents provided by Boehringer Ingelheim: Study Protocol  April 19, 2022Documents provided by Boehringer Ingelheim: Statistical Analysis Plan  May 25, 2023