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    Summary
    EudraCT Number:2010-022725-16
    Sponsor's Protocol Code Number:RE-0240/2010/EN
    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:2012-03-28
    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 number2010-022725-16
    A.3Full title of the trial
    INTRACORONARY ADMINISTRATION OF TENECTEPLASE VERSUS ABCIXIMAB AS ADJUNCTIVE TREATMENT DURING PRIMARY ANGIOPLASTY IN ACUTE MYOCARDIAL INFARCTION OF ANTERIOR LOCATION
    ADMINISTRACION INTRACORONARIA DE TENECTEPLASA FRENTE A ABCIXIMAB COMO TRATAMIENTO ADJUNTO DURANTE ANGIOPLASTIA PRIMARIA EN INFARTO AGUDO DE MIOCARDIO DE LOCALIZACION ANTERIOR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTRACORONARY ADMINISTRATION OF TENECTEPLASE VERSUS ABCIXIMAB AS ADJUNCTIVE TREATMENT DURING PRIMARY ANGIOPLASTY IN ACUTE MYOCARDIAL INFARCTION OF ANTERIOR LOCATION
    ADMINISTRACION INTRACORONARIA DE TENECTEPLASA FRENTE A ABCIXIMAB COMO TRATAMIENTO ADJUNTO DURANTE ANGIOPLASTIA PRIMARIA EN INFARTO AGUDO DE MIOCARDIO DE LOCALIZACION ANTERIOR
    A.3.2Name or abbreviated title of the trial where available
    INTRACORONARY TENECTEPLASE VERSUS ABCIXIMAB IN PRIMARY ANGIOPLASTY
    ADMINISTRACION INTRACORONARIA DE TENECTEPLASA FRENTE A ABCIXIMAB EN ANGIOPLASTIA PRIMARIA
    A.4.1Sponsor's protocol code numberRE-0240/2010/EN
    A.5.4Other Identifiers
    Name:COMITE ANDALUZ ENSAYOS CLINICOSNumber:0213/10
    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 SponsorFRANCISCO JOSE MORALES PONCE
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGRANT FROM: SUBVENCIONES PARA INVESTIGACION INDEPENDIENTE-DIRECCION GENERAL DE FARMACIA-ESPAÑA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION PARA LA GESTION DE LA INVESTIGACION BIOMEDICA DE CADIZ
    B.5.2Functional name of contact pointDIANA REGUEIRO
    B.5.3 Address:
    B.5.3.1Street AddressANA DE VIYA, 21-PLANTA 9
    B.5.3.2Town/ cityCADIZ
    B.5.3.3Post code11010
    B.5.3.4CountrySpain
    B.5.4Telephone number34956245019
    B.5.5Fax number34956245019
    B.5.6E-maildiana.regueiro@juntadeandalucia.es
    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 METALYSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENECTEPLASE
    D.3.9.1CAS number 191588-94-0
    D.3.9.4EV Substance CodeSUB04718MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 REOPRO
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor, B.V., Leiden, Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABCIXIMAB
    D.3.9.1CAS number 143653-53-6
    D.3.9.4EV Substance CodeSUB00233MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 REOPRO
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor, B.V., Leiden, Holanda
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABCIXIMAB
    D.3.9.1CAS number 143653-53-6
    D.3.9.4EV Substance CodeSUB00233MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Yes
    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
    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
    ACUTE MYOCARDIAL INFARCTION
    INFARTO AGUDO 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000894
    E.1.2Term Acute myocardial infarction, of anterolateral wall, initial episode of care
    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
    Primary angioplasty (primary PCI) is the preferred procedure to treat patients with ST- elevation acute myocardial infarction (STEMI). We sought to investigate whether, in patients with STEMI of anterior wall who are treated with standard pharmacological treatment (aspirin, a thienopiridine and heparin) and primary angioplasty, an intracoronary administration (instead of intravenous administration) of a fibrinolytic agent (tenecteplase) could be superior to that of the antiplatelet abciximab (a GP IIbIIIa platelet inhibitor) in the reduction of the final size of the myocardial infarction, on the basis of a higher efficacy of the fibrinolytic agent in the resolution of the macrovascular and microvascular obstruction by coronary thrombi
    La angioplastia primaria (ICP primaria) es el procedimiento de elección para tratar a los pacientes con infarto agudo de miocardio con elevación del ST (IAMEST). Nos proponemos investigar si, en pacientes con IAMEST de localización anterior tratados con la terapia farmacológica habitual (aspirina, una tienopiridina y heparina) que son sometidos a ICP primaria, la administración directa por vía intracoronaria (i.c.) de un fibrinolítico (tenecteplasa i.c.) (TNK i.c.) pueda ser superior a la terapia habitual con un antiagregante plaquetario inhibidor de la GP IIbIIIa (abciximab i.c.) en la reducción del tamaño final del infarto, a través de una mayor eficacia en la disminución de la obstrucción macro y microvascular por trombos intracoronarios.
    En definitiva, el objetivo primario del estudio es comprobar si hay diferencias entre ambos grupos de tratamiento en el tamaño final del infarto (valorado mediante angio-RMN a los 4 meses del IAMEST).
    E.2.2Secondary objectives of the trial
    -To assess which one of both antithrombotic treatments (tenecteplase vs abciximab) is more adequate to disolve coronary thrombus when administered during primary angioplasty in STEMI patients, and to improve myocardial perfusion
    -To analyze whether intracoronary tenecteplase reduces the final myocardial infarction more than the antiplatelet abciximab does (as assessed with both a cardiac magnetic resonance and the ROC curve of the release of myocardial damage biochemical markers)
    -To evaluate the effect of both drugs on the preservation of systolic and diastolic ventricular function
    -To evaluate which variables (including the study drugs) are predictive of ventricular remodeling
    - To identify which variables are predictive of adverse outcome in these patients
    -To evaluate the safety of the intracoronary administration of tenecteplase, compared with the safety of intracoronary abciximab
    -Averiguar el tipo de fármaco más apropiado (tenecteplasa vs abciximab) para disolver localmente el trombo coronario durante la angioplastia primaria del IAMEST, y mejorar la perfusión miocárdica.
    -Analizar si la fibrinolisis intracoronaria (TNK) reduce más el tamaño del infarto (mediante angio-RMN y mediante curva ROC de liberación de marcadores de daño miocárdico) que la habitual administración intracoronaria de un antiagregante potente (abciximab).
    -Evaluar el efecto de ambos fármacos sobre la preservación de la función ventricular (tanto sistólica como diastólica).
    -Indagar si el tipo de fármaco administrado, u otras variables (clínicas, ecocardiográficas angiográficas…), son predictoras de un remodelado ventricular adverso.
    -Identificar las variables predictoras de la evolución clínica de estos pacientes.
    -Comprobar la seguridad de la administración local (intracoronaria) de la tenecteplasa, y compararla con la del abciximab intracoronario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -ST-segment elevation acute myocardial infarction (STEMI) < 12 hours, with ST elevation ≥ 2mm in precordial leads in ECG (compatible with STEMI of anterior wall), or new-onset left-bundle branch block
    -Performance of urgent coronary angiography with evidence of a coronary flow limitant lesion in left-descending coronary artery (TIMI 0-2 flow) and intention to perform primary angioplasty
    -Written informed consent for study
    -Cuadro de IAMEST con evolución < 12 horas, junto a elevación del ST ≥ 2 mm en al menos 3 derivaciones precordiales contiguas compatible con IAMEST de localización anterior, o BCRIHH de nueva aparición.
    -Realización de coronariografía urgente con hallazgo de lesión responsable limitante al flujo en arteria coronaria descendente anterior (flujo TIMI 0-2), e intención de realizar angioplastia primaria.
    -Haber firmado el consentimiento informado al estudio
    E.4Principal exclusion criteria
    -Cardiogenic shock
    -Previous myocardial infarction (chronic)
    -Sever active bleeding
    -Contraindications for fibrinolytics or abciximab
    -Contraindicaction for cardiac magnetic resonance with contrast (angio-MNR), such as metallic intracraneal implants, pacemakers, moderate-to-severe renal insufficiency)
    -Age under 18
    -Pregnancy
    -Severe hepatic insufficiency
    -Severe diseases which can limit life expectancy under 12 months
    -Shock cardiogénico.
    -Infarto de miocardio previo.
    -Sangrado activo severo.
    -Contraindicación para fibrinolíticos o para abciximab.
    -Contraindicación para angio-RMN (implantes metálicos intracraneales, marcapasos, insuf renal moderada-severa).
    -Edad inferior a 18 años.
    -Embarazo.
    -Insuficiencia hepática severa.
    -Enfermedades severas con expectativa de vida < 12 meses.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between both treatment groups (intracoronary teneceplase group vs abciximab group) in final myocardial infarction size (as assessed with cardiac magnetic resonance with agent contrast -gadobutrol- performed 4 months after STEMI
    -Definition of final myocardial infarct size: mass of left ventricle which shows late enhancement with gadobutrol in the angio-MNR performed 4 months after STEMI (mass is expressed as grames and as percent of the whole mass of left ventricle), as assessed by an expertise radiologist who is unaware ot the study drug received by the patient during primary angioplasty
    Comparación entre ambos grupos de tratamiento en el tamaño final del infarto (valorados mediante angio-RMN con gadobutrol a los 4 meses del IAMEST).
    -Definición de tamaño final del infarto: Masa del VI que muestra realce tardío de gadobutrol en la angio-RMN realizada a los 4 meses del IAMEST (expresada tanto en gr como en porcentaje respecto a la masa total del VI), evaluado por un radiólogo experto que desconoce el fármaco asignado durante la angioplastia primaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cardiac magnetic resonance (with contrast agent) at four months after index event (STEMI)
    Angio-RMN: a los 4 meses del evento índice (IAMEST)
    E.5.2Secondary end point(s)
    ----Efficacy variables related to myocardial perfusion and ventricular function:
    -Electrocardiographic: Percent of ST segment elevation resolution in ECG performed 90 minutes after primary angioplasty (with respect to basal ECG, as expressed in mV and percent value)
    -Biochemical myocardial infarct size: Area under ROC curve of the release of CK and troponin
    -Angiographic: Corrected TIMI frame count, myocardial perfusion grade (myocardial blush grade, TMPG 0-3), left ventricle ejection fraction (%)
    -Echocardiographic (Doppler): deceleration time of mitral inflow, R/A ratio, E/E’ ratio, Tei index, end-systolic and end-diastolic left ventricle volumes, ejection fraction
    ---Safety variables: major cardiovascular events, and major bleeding events.
    -Definition of major cardiovascular events: death, new-onset myocardial infarction (chest pain plus new ST segment changes plus new CK-MB elevation), stroke or target-lesion revascularization during follow-up.
    -Definition of major bleeding events: those which result in death, a drop > 4 gr/dl in hemoglobin, intrapericardial effusion which results in cardiac tamponade, or any intracraneal bleeding
    ----Variables de eficacia relacionadas con la perfusión miocárdica y la función ventricular:
    -Electrocardiográficas: Porcentaje de resolución del ascenso del segmento ST a los 90 minutos de la angioplastia.
    -Tamaño enzimático del infarto: Area bajo la curva ROC de la liberación de CPK y troponina I.
    -Angiográficas: Flujo epicárdico (TIMI frame count corregido), perfusión miocárdica (grado de tatuaje miocárdico TMPG), y fracción de eyección (FE) del ventrículo izquierdo (VI).
    -Ecocardiográficas: tiempo desaceleración del llenado ventricular izquierdo, relación E/A de dicho llenado, cociente E/E’, índice Tei, volúmenes telediastólico y telesistólico del ventrículo izquierdo, fracción de eyección.
    ---Variables de seguridad: eventos cardiovasculares mayores, y hemorragias mayores.
    -Definición de eventos cardiovasculares mayores: muerte, reinfarto de miocardio (nuevo episodio de dolor torácico más nuevos cambios del segmento ST más nueva curva de elevación de CPK-MB), ictus, o necesidad de nueva revascularización de la lesión tratada durante la angioplastia primaria en el seguimiento.
    -Definición de hemorragias mayores: aquellas que provocan muerte, necesidad de transfusión, caída de la hemoglobina en más de 4 gr/dl, hemorragia intrapericárdica que provocase taponamiento cardiaco, o cualquier hemorragia intracraneal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ----Efficacy variables related to myocardial perfusion and ventricular function:
    -Electrocardiographic: At admission and 90 minutes after primary angioplasty
    -Biochemical myocardial infarct size: 72 hours after STEMI onset
    -Angiographic: Just after primary angioplasty, and 12-24 hours later (angiographic control 12-24 hours later)
    -Echocardiographic (Doppler): Basal and 6 months after STEMI
    ---Safety variables: major cardiovascular events, and major bleeding events: At 12-month follow-up
    ----Variables de eficacia relacionadas con la perfusión miocárdica y la función ventricular:
    -Electrocardiográficas: Al ingreso y a los 90 minutos de la angioplastia.
    -Tamaño enzimático del infarto: en las 72 horas siguientes al IAMEST.
    -Angiográficas: Justo tras la angioplastia, y a las 12-24 horas de la misma en nuevo control angiográfico.
    -Ecocardiográficas: En la primera semana del IAMEST (durante el ingreso) y a los 6 meses
    ---Variables de seguridad: eventos cardiovasculares mayores, y hemorragias mayores: en los primeros 12 meses de seguimiento
    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) Yes
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    AFTER RECRUITMENT OF 60 PATIENTS AND HAVING 12-MONTH FOLLOW-UP OF THEM
    TRAS INCLUIR 60 PACIENTES Y HABER COMPLETADO EL SEGUIMIENTO DE ELLOS AL AÑO DE SU INCLUSION
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state60
    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)
    THE EXPECTED FROM HIS CARDIAC DISEASE
    LA DERIVADA DE SU PATOLOGIA CARDIACA
    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 Decision2012-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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