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    Summary
    EudraCT Number:2013-001657-28
    Sponsor's Protocol Code Number:CTHC002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-28
    Trial results View 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 number2013-001657-28
    A.3Full title of the trial
    Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban: Prospective Management Trial (HoT-PE)
    Tratamiento domiciliario de pacientes con embolia pulmonar de bajo riesgo con el inhibidor oral del factor Xa rivaroxabán: un estudio prospectivo de gestión
    (HoT-PE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Home Treatment of Patients with Low-Risk Pulmonary Embolism with Rivaroxaban
    Tratamiento domiciliario de pacientes con embolia pulmonar de bajo riesgo con Rivaroxaban
    A.3.2Name or abbreviated title of the trial where available
    HoT-PE
    A.4.1Sponsor's protocol code numberCTHC002
    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 SponsorUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.1.3.4CountryGermany
    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 supportBayer Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg University Mainz
    B.5.2Functional name of contact pointProf. Dr. S. Konstantinides
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post codeD-55131
    B.5.3.4CountryGermany
    B.5.4Telephone number00496131178382
    B.5.5Fax number00496131178461
    B.5.6E-mailstavros.konstantinides@unimedizin-mainz.de
    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 Xarelto 15 mg Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameXarelto 15 mg Film-coated tablets
    D.3.2Product code B01AF01
    D.3.4Pharmaceutical form 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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Xarelto 20 mg Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameXarelto 20 mg Film-coated tablets
    D.3.2Product code B01AF01
    D.3.4Pharmaceutical form 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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Acute low-risk pulmonary embolism (PE)
    Embolia pulmonar aguda de bajo riesgo
    E.1.1.1Medical condition in easily understood language
    Acute low-risk pulmonary embolism
    Embolia pulmonar aguda de bajo riesgo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10037379
    E.1.2Term Pulmonary embolism and thrombosis
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether early discharge and out-of-hospital treatment of patients with low-risk acute PE (as defined by the inclusion and exclusion criteria) with the new oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe.
    Determinar si el alta temprana y el tratamiento fuera del hospital de los pacientes con EP aguda de bajo riesgo (según la definición de los criterios de inclusión y exclusión) con el nuevo inhibidor oral del factor Xa rivaroxabán son viables, eficaces y seguros.
    E.2.2Secondary objectives of the trial
    -To determine whether early discharge and out-of-hospital treatment of low-risk acute PE with the new oral factor Xa inhibitor rivaroxaban can result in good quality of life and patient satisfaction
    -To obtain valid health economic variables as a basis for description of resource utilization, including validation of a disease-specific quality of life questionnaire, and of existing Markov models.
    - Determinar si el alta temprana y el tratamiento fuera del hospital de los pacientes con EP aguda de bajo riesgo con el nuevo inhibidor oral del factor Xa rivaroxabán puede resultar en una buena calidad de vida y la satisfacción del paciente, y
    - Obtener variables económicas de salud válidas como base para la descripción de la utilización de los recursos, incluida la validación de un cuestionario sobre la calidad de vida específico de la enfermedad y de los modelos de Markov existentes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥18 years;
    2) Ability of subject to understand character and individual consequences of clinical trial;
    3) Signed and dated informed consent of the subject available before the start of any specific trial procedures;
    4) Women of childbearing potential have to practice a medically accepted contraception (non-hormonal intrauterine device, two independent barriers, female or male surgical sterilization, or two years postmeno-pausal) during the trial, and a negative pregnancy test (serum or urine) should be available before inclusion in the trial;
    5) Objectively confirmed diagnosis of acute PE by multidetector computed tomographic (CT) pulmonary angiography, pulmonary angiography, or V/Q lung scan according to established diagnostic criteria, with or without symptomatic deep vein thrombosis;
    6) Absence of right ventricular (RV) enlargement or dysfunction, and of free floating thrombi
    in the right atrium or right ventricle on echocardiography or computed tomography.
    On echocardiography, RV enlargement/dysfunction is absent when both criteria listed
    below are met:
    - Right/left ventricular end-diastolic diameter ratio < 0.9 (apical or subcostal 4-chamber
    view)
    - No paradoxical motion of the interventricular septum
    On CT angiography, RV enlargement/dysfunction is absent when the following criterion is
    met:
    - Right/left short-axis diameter ratio < 0.9 (transverse plane)
    1) Edad ≥18 años.
    2) Sujetos con capacidad para comprender el carácter y las consecuencias individuales del estudio clínico.
    3) Consentimiento informado firmado y fechado del sujeto disponible antes del inicio de cualquier procedimiento específico del estudio.
    4) Las mujeres en edad fértil deberán usar métodos anticonceptivos aceptables desde el punto de vista médico (dispositivo intrauterino no hormonal, dos barreras independientes, esterilización quirúrgica femenina o masculina, o menopausia desde hace dos años); también deberán disponer de una prueba de embarazo negativa (en suero u orina) antes de la inclusión en el estudio.
    5) Diagnóstico de EP aguda confirmado de manera objetiva por angiografía pulmonar mediante tomografía axial computarizada (TAC) multidetectora, angiografía pulmonar o gammagrafía pulmonar V/Q de acuerdo con los criterios de diagnóstico establecidos, con o sin trombosis venosa profunda sintomática.
    6) Ausencia de agrandamiento o disfunción del ventrículo derecho (VD), así como de trombos de flotación libre en la aurícula derecha o el ventrículo derecho en el ecocardiograma o la tomografía axial computarizada.
    El ecocardiograma no muestra ningún agrandamiento/disfunción del VD cuando se cumplen los dos criterios que aparecen a continuación:
    - Diámetro final diastólico ventricular derecho/izquierdo ≤ 0,9 (vista apical o subcostal de las cuatro cavidades)
    - Ausencia de movimiento paradójico del septo interventricular
    En la angiografía TAC, ausencia de agrandamiento/disfunción del VD cuando se cumple el siguiente criterio:
    - Diámetro del eje corto derecho/izquierdo <0,9 (plano transversal)
    E.4Principal exclusion criteria
    -Hemodynamic instability at presentation, indicated by at least one of the following: (i) systolic blood pressure (SBP) < 100 mm Hg, or heart rate >100 beats per minute, or SBP drop by > 40 mm Hg, for > 15 min; (ii) need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of >100 mm Hg; (iii) need for cardiopulmonary resuscitation;
    -Right ventricular (RV) enlargement or dysfunction, or free floating thrombi in the right atrium or right ventricle, detected by echocardiography or computed tomography;
    -Treatment with low-molecular-weight heparin, fondaparinux, or unfractionated heparin for more than 48 hours, or more than a single dose of a vitamin K antagonist prior to inclusion in the study;
    -Treatment with rivaroxaban, dabigatran, apixaban, edoxaban or any other new generation antithrombotics on admission;
    -Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
    - Need for supplemental oxygen administration to maintain oxygen saturation >90%;
    -Pain requiring parenteral administration of analgesic agents;
    -Other medical conditions/comorbidities requiring hospitalization;
    - Acute PE diagnosed in a patient already hospitalized for another condition;
    - Pregnancy or lactation;
    - Active bleeding or known significant bleeding risk;
    -Severe renal insufficiency (estimated GFR <15 ml/min/1.73m2) or end-stage renal disease;
    -Severe hepatic failure;
    -Known allergy or intolerance to rivaroxaban;
    -Concomitant administration of strong inhibitors of P-gp and CYP3A4 such as azole antimycotic agents or HIV protease inhibitors;
    -Need for long-term treatment vitamin K antagonists, or for antiplatelet agents except acetylsalicylic acid at a dosage <100 mg/day;
    -Non-compliance or inability to adhere to treatment or to the follow-up visits; or lack of a family environment or support system for home treatment;
    -Life expectancy less than 3 months.
    1) Embarazo o lactancia.
    2) Antecedentes de hipersensibilidad al producto en fase de investigación clínica, a cualquier fármaco con estructura química similar o a cualquier excipiente presente en la forma farmacéutica del producto en fase de investigación clínica.
    3) Participación en otros estudios clínicos durante el estudio clínico actual o en los últimos seis meses.
    4) Condición médica o psicológica que no permita la finalización del estudio o firmar el consentimiento informado.
    5) Inestabilidad hemodinámica en la presentación, indicada por al menos uno de los siguientes: (i) presión arterial sistólica (PAS) < 100 mm Hg, frecuencia cardíaca >100 latidos por minuto o disminución de la PAS un > 40 mm Hg durante > 15 minutos; (ii) necesidad de catecolaminas para mantener una perfusión adecuada de los órganos y una presión arterial sistólica de >100 mm Hg; (iii) necesidad de reanimación cardiopulmonar.
    6) Tratamiento del episodio agudo (índice) con heparina no fraccionada, heparina de bajo peso molecular, fondaparinux o un anticoagulante oral nuevo durante más de 48 horas, o con más de una dosis única de un antagonista de la vitamina K antes de la inclusión en el estudio.
    7) Tratamiento crónico con un antagonista de la vitamina K, rivaroxabán o cualquier otro fármaco anticoagulante oral o parenteral.
    8) Uso de un agente fibrinolítico, trombectomía quirúrgica, aspiración intervencionista de trombos (transcatéter) o lisis, o uso de un filtro en la vena cava para tratar el episodio índice de EP.
    9) Necesidad de administración de oxígeno suplementario para mantener una saturación de oxígeno >90 %.
    10) Dolor que requiere administración parenteral de agentes analgésicos.
    11) Otras condiciones médicas/enfermedades concomitantes que requieren hospitalización.
    12) EP aguda diagnosticada en un paciente hospitalizado por otra enfermedad.
    13) Hemorragia activa o riesgo importante conocido de hemorragia.
    14) Insuficiencia renal grave (tasa de filtración glomerular estimada <15 ml/min/1,73m2 según la fórmula MDRD) o insuficiencia renal en etapa terminal.
    15) Insuficiencia hepática grave.
    16) Administración concomitante de inhibidores potentes de P-gp y CYP3A4 tales como agentes antimicóticos azoles o inhibidores de la proteasa del VIH.
    17) Necesidad de un tratamiento a largo plazo con antagonistas de la vitamina K o de agentes antiplaquetarios, con excepción del ácido acetilsalicílico a una dosis <100 mg/día.
    18) Incumplimiento o imposibilidad de adherirse al tratamiento o las visitas de seguimiento; falta de un entorno familiar o sistema de apoyo para el tratamiento domiciliario.
    19) Esperanza de vida inferior a 3 meses.
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic recurrent venous thromboembolism (VTE) or death related to pulmonary embolism
    Tromboembolismo venoso recurrente (TEV) sintomático o muerte relacionada con una embolia pulmonar en los tres meses siguientes a la inclusión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 3 months after enrolment
    en los 3 meses siguientes después del reclutamiento
    E.5.2Secondary end point(s)
    - All-cause mortality within 7 days;
    - All-cause mortality within 3 weeks;
    - All-cause mortality within 3 months;
    - Overall duration of hospital stay (index event and repeated hospitalizations due to PE
    [index or recurrent event] or to a bleeding event) within 3 months;
    - Rehospitalization due to PE (index or recurrent event) or to a bleeding event within 3
    months;
    - Generic and disease-specific quality of life at baseline, 1 week, 3 weeks, and 3 months;
    - Treatment satisfaction at 3 weeks and 3 months;
    - Utilization of health care resources at 3 weeks and 3 months;
    - All-cause mortality at one year.
    Safety outcomes:
    - Major bleeding, based on the ISTH definition, within 7 days, 3 weeks, and 3 months;
    - Clinically relevant bleeding, defined as a composite of major or clinically relevant non-
    major bleeding, within 7 days, 3 weeks, and 3 months;
    - Serious adverse events (SAE) within 7 days, 3 weeks, and 3 months.
    1) Mortalidad por cualquier causa en los 7 días siguientes.
    2) Mortalidad por cualquier causa en las 3 semanas siguientes.
    3) Mortalidad por cualquier causa en los 3 meses siguientes.
    4) Duración total de la estancia hospitalaria (episodio índice y hospitalizaciones repetidas por la EP [episodio índice o recurrente] o un episodio hemorrágico) en los 3 meses siguientes.
    5) Rehospitalización debido a la EP (episodio índice o recurrente) o a un episodio hemorrágico en los 3 meses siguientes.
    6) Calidad de vida general y específica de la enfermedad al inicio del estudio, 1 semana, 3 semanas y 3 meses después.
    7) Satisfacción con el tratamiento 3 semanas y 3 meses después.
    8) Utilización de recursos sanitarios 3 semanas y 3 meses después.
    9) Mortalidad por cualquier causa un año después.
    Variables de seguridad:
    1) Hemorragias importantes, con base a la definición de ISTH, en los 7 días, 3 semanas y 3 meses siguientes.
    2) Hemorragia clínicamente relevante, definida como un conjunto de hemorragia importante o menor de importancia clínica, en los 7 días, 3 semanas y 3 meses siguientes.
    3) Acontecimientos adversos graves (AAG) en los 7 días, 3 semanas y 3 meses siguientes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days, 3 weeks, and 3 months
    7 días, 3 semanas y 3 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1100
    F.4.2.2In the whole clinical trial 1100
    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)
    Rivaroxaban as study medication will be taken for a period of 3 months. After that period continuation of anticoagulation and the anticoagulant drug to be used will be at the discretion of the patient’s physician.
    Rivaroxabán se tomará durante un total de al menos tres meses. Tras ese período, la decisión sobre la continuación de la anticoagulación y del fármaco anticoagulante quedará a discreción del médico del paciente.
    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 Decision2016-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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