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    Summary
    EudraCT Number:2019-001037-13
    Sponsor's Protocol Code Number:1245-0202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-001037-13
    A.3Full title of the trial
    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
    Ensayo de superioridad optimizado, multicéntrico, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo para evaluar el efecto de empagliflozina en la hospitalización por insuficiencia cardíaca y la mortalidad en pacientes con infarto agudo de miocardio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether empagliflozin can lower the risk of heart failure and death in people who had a heart attack (myocardial infarction)
    Estudio para comprobar si empagliflozina puede reducir el riesgo de insuficiencia cardíaca y muerte en personas que han tenido un ataque al corazón (infarto de miocardio)
    A.3.2Name or abbreviated title of the trial where available
    EMPACT-MI
    A.4.1Sponsor's protocol code number1245-0202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04509674
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Jardiance®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEmpagliflozin
    D.3.2Product code BI 10773
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeBI 10773
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocardial Infarction
    Infarto Agudo de Miocardio
    E.1.1.1Medical condition in easily understood language
    Heart attack (myocardial infarction)
    Ataque al corazón (infarto de miocardio)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this event-driven trial is to demonstrate the superiority of empagliflozin 10 mg once daily versus placebo, in addition to standard of care, for the reduction of the composite endpoint of time to first heart failure hospitalisation or all-cause mortality in high-risk patients hospitalised for acute MI.
    El objetivo principal de este ensayo motivado por los acontecimientos es demostrar la superioridad de 10 mg de empagliflozina una vez al día frente a placebo, además del tratamiento estándar, en la reducción del criterio de valoración compuesto del tiempo hasta la primera hospitalización por insuficiencia cardíaca o muerte por cualquier causa en pacientes con riesgo alto hospitalizados por IM agudo.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
    • Diagnosis of acute MI (type 1 per the Universal Definition of Myocardial Infarction [R20-0005]): STEMI or NSTEMI with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital MI as qualifying event, randomisation must still occur within 14 days of hospital admission.
    • High risk of HF, defined as EITHER
    a) 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 hospitalisation.
    OR
    b) Newly developed LVEF < 45% as measured by echocardiography, ventriculography, cardiac CT, 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
    - eGFR < 60 ml/min/1.73m2 (according to creatinine from most recent local lab during the index hospitalisation and calculated with the CKD-EPI formula)
    - Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI)
    - Type 2 diabetes mellitus (prior or new diagnosis)
    - NTproBNP >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; 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 >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)
    Criterios de inclusión principales:
    -Consentimiento informado por escrito firmado y fechado antes de la inscripción en el ensayo, de acuerdo con las BPC de la ICH y la legislación local.
    -Diagnóstico de IM agudo (tipo 1 según la Definición Universal del Infarto de Miocardio [R20-0005]): IMEST o IMSEST con la aleatorización realizada, como máximo, 14 días naturales después del ingreso hospitalario. En el caso de los pacientes con un IM intrahospitalario utilizado como el acontecimiento de cualificación, la aleatorización también deberá realizarse en los 14 días siguientes al ingreso hospitalario.
    -Riesgo alto de IC, definido como
    a) Síntomas (p. ej., disnea, disminución de la tolerancia al ejercicio, fatiga) o signos de congestión (p. ej., estertores pulmonares, crepitantes, presión venosa yugular elevada, congestión en la radiografía de tórax) que requieran tratamiento (p. ej., aumento o inicio de tratamiento diurético oral, tratamiento diurético i.v., agente vasoactivo i.v., intervención mecánica, etc.) en cualquier momento durante la hospitalización.
    O BIEN
    b) FEVI <45 % recién desarrollada, medida mediante ecocardiografía, ventriculografía, TAC, RM o gammagrafía cardíacas durante la hospitalización de referencia.
    Además, al menos uno de los siguientes factores de riesgo:
    -Edad ≥65 años.
    -FEVI <35 % recién desarrollada.
    -IM anterior (antes del IM de referencia) documentado en la historia clínica.
    -TFGe <60 ml/min/1,73m2 (según la creatinina del análisis del laboratorio local más reciente durante la hospitalización de referencia y calculada con la fórmula CKD-EPI).
    -Fibrilación auricular (persistente o permanente; si es paroxística, solo es válida si está asociada al IM de referencia).
    -Diabetes mellitus de tipo 2 (diagnóstico previo o nuevo).
    -NTproBNP >1400 pg/ml para pacientes en ritmo sinusal, >2800 pg/ml si hay fibrilación auricular; BNP >350 pg/ml para pacientes en ritmo sinusal, >700 pg/ml si hay fibrilación auricular, medidos en cualquier momento durante la hospitalización.
    -Ácido úrico >7,5 mg/dl (>446 μmol/l), medido en cualquier momento durante la hospitalización.
    -Presión sistólica de la arteria pulmonar >40 mmHg (no invasiva [normalmente obtenida de una ecocardiografía posterior al IM clínicamente indicada] o invasiva, en cualquier momento durante la hospitalización).
    -Paciente no revascularizado (y sin revascularización prevista) para el IM de referencia (incluye, por ejemplo, a pacientes en los que no se realiza angiografía, intentos de revascularización sin éxito, aterosclerosis difusa no susceptible de intervención, pero NO incluye casos en los que no se realizó la revascularización debido a arterias coronarias no obstructivas).
    -Enfermedad coronaria de 3 vasos en el momento del IM de referencia.
    -Diagnóstico de enfermedad arterial periférica (enfermedad vascular extracoronaria, p. ej., enfermedad arterial de las extremidades inferiores o enfermedad arterial carotídea).
    E.4Principal exclusion criteria
    • Diagnosis of chronic 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 hospitalisation) or on dialysis
    • Type I diabetes mellitus
    • History of ketoacidosis
    Criterios de exclusión principales:
    -Diagnóstico de IC crónica antes del IM de referencia.
    -Presión arterial sistólica >90 mmHg en la aleatorización.
    -Choque cardiogénico o uso de inotrópicos i.v. en las últimas 24 horas antes de la aleatorización.
    -Derivación aortocoronaria prevista en el momento de la aleatorización.
    -Diagnóstico actual de miocardiopatía de Takotsubo.
    -Cualquier valvulopatía grave (estenótica o regurgitante) en curso.
    -TFGe <20 ml/min/1,73m2 (usando la fórmula CKD-EPI con el valor de creatinina más reciente del laboratorio local durante la hospitalización) o en diálisis.
    -Diabetes mellitus de tipo 1.
    -Antecedentes de cetoacidosis.
    E.5 End points
    E.5.1Primary end point(s)
    • Composite of time to first HHF or all-cause mortality
    -Criterio compuesto del tiempo hasta la primera HIC o muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.
    Desde el día de la primera aleatorización hasta el número total de pacientes con criterios de valoración reportados por el investigador alcance un objetivo de 532.
    E.5.2Secondary end point(s)
    • Total number of HHF or all-cause mortality
    • Total number of non-elective CV hospitalization or all-cause mortality
    • Total number of non-elective all-cause hospitalisation or all-cause mortality
    • Total number of hospitalisation for MI or all-cause mortality
    -Número total de HIC o muertes por cualquier causa.
    -Número total de hospitalizaciones no programadas por causas CV o muertes por cualquier causa.
    -Número total de hospitalizaciones no programadas por cualquier causa o muertes por cualquier causa.
    -Número total de hospitalizaciones por IM o muertes por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.
    Desde el día de la primera aleatorización hasta el número total de pacientes con criterios de valoración reportados por el investigador alcance un objetivo de 532.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA152
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    India
    Israel
    Korea, Democratic People's Republic of
    Mexico
    Russian Federation
    Serbia
    Ukraine
    United States
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Netherlands
    Poland
    Romania
    Spain
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1325
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1987
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1182
    F.4.2.2In the whole clinical trial 3312
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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