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    Summary
    EudraCT Number:2017-001834-25
    Sponsor's Protocol Code Number:MasterDapt_Spain
    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:2017-10-10
    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 number2017-001834-25
    A.3Full title of the trial
    MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen – MASTER DAPT
    Gestión de pacientes con alto riesgo de hemorragia tras implantación de stent de polímero biodegradable con TAPD reducida frente a TADP prolongada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare two medication therapies to prevent thrombus (blood cloth) formation following the successful treatment of a coronary heart disease with expansion of coronary stent (metallic tube) covered with medication (Drug Eluting Stent-DES): a shortened versus a prolonged dual antiplatelet therapy (DAPT, drugs that inhibit bloodplatelets, blood cells involved in the thrombus formation process).
    Para comparar dos terapias medicamentosas para prevenir la formación de trombo (coágulo de sangre) seguido al tratamiento exitoso de una enfermedad coronaria con expansión del stent coronario (tubo metálico) cubierto con medicación (stent liberador de fármaco): una terapia antiplaquetaria doble acortada frente a una prolongada (DAPT, fármacos que inhiben las plaquetas sanguíneas, células sanguíneas implicadas en el proceso de la formación de trombos).
    A.3.2Name or abbreviated title of the trial where available
    MASTER DAPT
    A.4.1Sponsor's protocol code numberMasterDapt_Spain
    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 SponsorECRI-9
    B.1.3.4CountryNetherlands
    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 supportTerumo Europe NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationECRI-9
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressWestblaak 98
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3012 KM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031102062828
    B.5.5Fax number0031102062844
    B.5.6E-mailinfo@ecri-trials.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 ADIRO 100 mg comprimidos gastrorresistentes EFG Ácido acetilsalicílico
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA, S.L
    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.3.1Product nameADIRO
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 Brilique 60 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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.3.1Product nameBrilique
    D.3.4Pharmaceutical form 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 INNTicagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeTicagrelor
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 3
    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 Plavix 75 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Clir SNC
    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.3.1Product namePlavix
    D.3.4Pharmaceutical form 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 INNClopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.2Current sponsor codeClopidogrel
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High bleeding risk population represents a significant proportion of coronary artery disease (CAD) patients undergoing coronary stent implantation. Decisions regarding the duration of dual antiplatelet therapy (DAPT) after stent implantation are difficult, especially after implantation of newer generation drug eluting stents (DES) due to conflicting results from recent trials. High bleeding risk patients either male or female eligible for percutaneous coronary intervention will be included.
    La población con alto riesgo de sangrado representa una proporción significativa de pacientes con enfermedad coronaria sometidos a implante de stents coronarios. Las decisiones con respecto a la duración del DAPT después de la implantación del stent son difíciles, especialmente después de la implantación de la nueva generación de DES debido a los resultados contradictorios de los ensayos recientes. Se incluirán pacientes con alto riesgo de hemorragia (hombres o mujeres) elegibles para la ICP
    E.1.1.1Medical condition in easily understood language
    Patients with different levels of chest pain, due to poor blood flow to the heart, and an increased risk for bleeding. A stent is placed to reopen the artery followed by treatment with medicines.
    Pacientes con diferentes niveles de dolor torácico, debido al mal flujo sanguíneo al corazón, riesgo de sangrado. Se coloca un stent para reabrir la arteria seguido a un tratamiento con medicamentos.
    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 SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    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 objective is to compare, within current guidelines and instructions for use, an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting High Bleeding Risk features.
    En el marco de las guías actuales y de las instrucciones de uso, el objetivo es comparar una TAPD de duración reducida frente a una TAPD de duración prolongada tras la implantación de un stent liberador de sirolimus Ultimaster revestido de polímero biodegradable en pacientes con un alto riesgo de hemorragia (HBR).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met:
    1) At least one among the High Bleeding Risk (HBR) criteria (as defined below) is met.
    2) All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis <20% by visual estimation
    3) Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operator’s opinion.
    4) All stages of PCI are complete (if any) and no further PCI is planned.
    Inclusion criteria at one-month randomization visit
    At randomization visit (one month after index PCI), the following criteria must be met:
    1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
    2) Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
    3) If not on OAC,
    a.Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
    b.Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
    4)If on OAC
    a.Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
    b.Patient is on clopidogrel for at least 7 days
    Definition of HBR
    Post-PCI patients are at HBR if at least one of the following criteria applies:
    •Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
    •Recent (<12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
    •Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
    •Age equal or greater than 75 years
    •Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
    •Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion within 4 weeks before inclusion.
    •Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
    •Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
    •Stroke at any time or TIA in the previous 6 months
    •PRECISE DAPT score of 25 or greater
    Tras la ICP inicial, los pacientes a partir de 18 años son aptos para su inclusión en el estudio si se cumplen los siguientes criterios.
    1) Se cumple al menos uno de los criterios referentes al HBR (según se describe a continuación).
    2) Todas las lesiones se tratan satisfactoriamente con un stent Ultimaster en el contexto de la atención clínica de rutina, es decir, un diámetro de estenosis angiográfica posterior a la intervención de < 20 % mediante evaluación visual.
    3) Ausencia de complicaciones angiográficas que limiten el flujo (es decir, disección no tratada significativa u oclusión de ramal lateral importante), que requieran una TAPD de duración prolongada de acuerdo con la opinión del operador.
    4) Todas las fases de la ICP se han completado (si las hubiera) y no hay otras ICP previstas.


    Criterios de inclusión en la visita de aleatorización al cabo de un mes
    En la visita de aleatorización (un mes después de la ICP inicial), deben cumplirse los siguientes criterios:
    1) Se cumple al menos un criterio relativo al HBR (según se describe a continuación) o en lo referente al episodio hemorrágico relacionado con un sitio distinto al de acceso tras la ICP que requiere atención médica.
    2) Periodo clínico de 30 días sin problemas, es decir, sin infarto de miocardio espontáneo, reestenosis sintomática, trombosis del stent, ictus ni cualquier tipo de revascularización (coronaria y no coronaria) que requiera una TAPD prolongada.
    3) Si no se utilizan ACO:
    a. Paciente con una TAPD a base de aspirina más inhibidor del receptor P2Y12.
    b. Paciente con un tipo de inhibidor del receptor P2Y12 durante al menos 7 días (es decir, no se han alternado los inhibidores del receptor P2Y12 orales en los 7 días previos).
    4) Si se utilizan ACO:
    a. Paciente con el mismo tipo de ACO (por ejemplo, antagonista de la vitamina K o NACO) durante al menos 7 días.
    b. Paciente con clopidogrel durante al menos 7 días.
    Definición de HBR
    Los pacientes que han sido sometidos a una ICP presentan un alto riesgo de hemorragia (HBR) si se cumple al menos uno de los siguientes criterios:
    • Indicación clínica de tratamiento con anticoagulantes orales (ACO) durante al menos 12 meses.
    • Episodio(s) reciente(s) (<12 meses) de hemorragia en un sitio distinto al de acceso, que requiere(n) atención médica (es decir, hemorragia procesable).
    • Episodios de hemorragia anteriores que requirieron hospitalización si la causa subyacente no ha sido tratada definitivamente (es decir, extirpación quirúrgica de la causa de la hemorragia).
    • Edad de 75 años o más.
    • Condiciones sistémicas asociadas a un mayor riesgo de hemorragia (por ejemplo, trastornos hematológicos, incluido un historial de trombocitopenia o trombocitopenia actual definidos de acuerdo a un recuento de plaquetas <100.000/mm3 (<100 x 109/L), o cualquier trastorno de coagulación conocido asociado al aumento del riesgo de hemorragia.
    • Anemia documentada definida de acuerdo a niveles de hemoglobina repetidos <11 g/dl o transfusión en las 4 semanas antes de la aleatorización.
    • Necesidad de tratamiento crónico con esteroides o fármacos antiinflamatorios no esteroideos.
    • Neoplasia diagnosticada (distinta de la cutánea) que presenta un alto riesgo de hemorragia, incluyendo la neoplasia gastrointestinal, genitouretral/renal y pulmonar.
    • Ictus en cualquier momento o AIT en los 6 meses anteriores.
    • Puntuación en el índice PRECISE TAPD de 25 o superior
    E.4Principal exclusion criteria
    Patients are not eligible if any of the following applies
    1)Treated with stents other than Ultimaster stent within 6 months prior to index procedure
    2)Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
    3)Treated with a bioresorbable scaffold at any time prior to index procedure
    4)Cannot provide written informed consent
    5)Under judicial protection, tutorship or curatorship
    6)Unable to understand and follow study-related instructions or unable to comply with study protocol
    7)Active bleeding requiring medical attention (BARC≥2) on randomization visit
    8)Life expectancy less than one year
    9)Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
    10)Any planned and anticipated PCI
    11)Participation in another trial
    12)Pregnant or breast feeding women
    Paciente no apto si cumple alguno de los siguientes criterios:
    1) Tratado con stents distintos del Ultimaster en los 6 meses anteriores al procedimiento inicial.
    2) Tratado por reestenosis intra-stent o trombosis del stent en la ICP inicial o en los 6 meses anteriores.
    3) Tratado con un scaffold biodegradable en cualquier momento antes del procedimiento inicial.
    4) No puede facilitar el consentimiento informado por escrito.
    5) Bajo protección, tutela o cautela judicial.
    6) No puede comprender ni aplicar las instrucciones relativas al estudio o no puede cumplir con el protocolo del estudio.
    7) Hemorragia activa que requiere atención médica (BARC≥2) en la visita de aleatorización.
    8) Esperanza de vida inferior a un año.
    9) Hipersensibilidad conocida o alergia a la aspirina, al clopidogrel, al ticagrelor, al prasugrel, al cromo-cobalto o al sirolimus.
    10) Alguna ICP programada y prevista.
    11) Participación en otro ensayo.
    12) Mujer embarazada o amamantando.
    E.5 End points
    E.5.1Primary end point(s)
    This study has 3 primary endpoints:
    1)Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
    2)Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
    3)Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
    The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.
    Este estudio tiene 3 variables principales:
    1) Variables clínicas adversas netas (VCAN) definidos como una composición de muerte por cualquier causa, infarto de miocardio, ictus y hemorragias de tipo 3 o 5 según la clasificación BARC.
    2) Eventos adversos cardíacos y vasculares cerebrales mayores (MACCE, por sus siglas en inglés) definidos como una composición de muerte por cualquier causa, infarto de miocardio e ictus.
    3) Hemorragia mayor o no mayor pero clínicamente relevante (MCB, por sus siglas en inglés) definida como una composición de eventos hemorrágicos tipo 2, 3 y 5 según la clasificación BARC.
    Los principales análisis evalúan la aparición de las variables principales entre la aleatorización y los 11 meses posteriores. En análisis secundarios, se evalúa la aparición de las variables principales entre la aleatorización y los 15 meses posteriores a la ICP inicial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    11 and 15 months after randomization
    11 y 15 meses posteriores a la aleatorización
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are the following:
    1)The individual components of each primary endpoint
    2)The composite of cardiovascular death, MI, and stroke
    3)The composite of cardiovascular death, MI, and urgent revascularization
    4)The composite of cardiovascular death, MI, and any unplanned revascularization
    5)Death from cardiovascular causes
    6)The composite of definite or probable stent thrombosis
    7)Myocardial infarction
    8)Any target lesion revascularisation
    9)Urgent target lesion revascularization
    10)Any target vessel revascularization
    11)Urgent target vessel revascularization
    12)Any non-target vessel revascularization
    13)Any urgent non-target vessel revascularization
    14)Bleeding events according to the BARC, TIMI and GUSTO classification
    15)Transfusion rates both in patients with and/or without clinically detected over bleeding
    Las criterios variables secundarias del estudio son las siguientes:
    1) Los componentes individuales de cada composición de las variables principales.
    2) La composición de la muerte cardiovascular, infarto de miocardio e ictus.
    3) La composición de la muerte cardiovascular, infarto de miocardio y cualquier tipo de revascularización.
    4) Muerte por causas cardiovasculares.
    5) La composición de la trombosis del stent definitiva o probable.
    6) Infarto de miocardio.
    7) Cualquier revascularización del vaso tratado.
    8) Revascularización urgente del vaso objeto.
    9) Revascularización urgente del vaso no objeto.
    10) Revascularización clínicamente indicada del vaso no objeto.
    11) Hemorragias conforme a la clasificación BARC, TIMI y GUSTO.
    12) Tasas de transfusión en pacientes con o sin hemorragia evidente detectada clínicamente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    11 and 15 months after randomization
    11 y 15 meses posteriores a la aleatorización
    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) No
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Long term Dual Antiplatelet Therapy
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1215
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-10-10. Yes
    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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1350
    F.4.2.2In the whole clinical trial 1350
    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 Decision2017-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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