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    Summary
    EudraCT Number:2018-001013-32
    Sponsor's Protocol Code Number:CV-185-685
    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:2018-08-10
    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 number2018-001013-32
    A.3Full title of the trial
    ANTITHROMBOTIC THERAPY AFTER LEFT ATRIAL APPENDAGE OCCLUSION: DOUBLE ANTIPLATELET THERAPY VS. APIXABAN
    TRATAMIENTO ANTITROMBÓTICO POSTERIOR AL CIERRE PERCUTÁNEO DE OREJUELA IZQUIERDA: APIXABAN VERSUS DOBLE ANTIAGREGACIÓN.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ADALA
    ADALA
    A.3.2Name or abbreviated title of the trial where available
    ADALA
    ADALA
    A.4.1Sponsor's protocol code numberCV-185-685
    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 SponsorHOSPITAL CLÍNIC BARCELONA
    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 supportBRISTOL MYERS SQUIBB
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLÍNIC BARCELONA
    B.5.2Functional name of contact pointANNA CAMPOS
    B.5.3 Address:
    B.5.3.1Street AddressVILLARROEL 170
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34934518746
    B.5.6E-mailacampos@clinic.cat
    D. IMP Identification
    D.IMP: 1
    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 ELIQUIS
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    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 nameAPIXABAN
    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 INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codePF-0465257/BMS-562247-01
    D.3.9.3Other descriptive nameApixaban
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    ATRIAL FIBRILLATION IN PATIENTS AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC)
    FIBRILACIÓN AURICULAR EN PACIENTES DESPUÉS DEL CIERRE DE OREJUELA IZQUIERDA
    E.1.1.1Medical condition in easily understood language
    ATRIAL FIBRILLATION
    FIBRILACIÓN AURICULAR
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TO DEMONSTRATE SUPERIORITY OF A STRATEGY OF ANTICOAGULATION WITH APIXABAN 5 MG/2.5 MG BID AS COMPARED WITH THE CURRENT STANDARD OF CARE (DUAL ANTIPLATELET THERAPY) AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC) IN PATIENTS WITH ATRIAL FIBRILLATION
    EL OBJETIVO DEL ESTUDIO ES DETERMINAR CUÁL ES EL MEJOR TRATAMIENTO MÉDICO TRAS EL IMPLANTE DE UN DISPOSITIVO DE CIERRE DE OREJUELA TIPO AMULET. EL TRATAMIENTO TRAS EL CIERRE DE OREJUELA EN PACIENTES EN LOS QUE LA INDICACIÓN DE CIERRE HA SIDO UN EVENTO HEMORRÁGICO NO HA SIDO ADECUADAMENTE ESTUDIADA Y NO EXISTEN EN LA ACTUALIDAD DATOS SUFICIENTES PARA ESTABLECER CUAL ES EL TRATMIENTO QUE HAN DE RECIBIR ESTOS PACIENTES. POR ELLO EN EL ESTUDIO ADALA SE COMPARAN EL TRATAMIENTO QUE SE PAUTABA HABITUALMENTE (DOBLE ANTIAGREGACIÓN CON ASPIRINA Y CLOPIDOGREL) FRENTE A UN ANTICOAGULANTE ORAL DE NUEVA GENERACIÓN A DOSIS REDUCIDA (APIXABAN)
    E.2.2Secondary objectives of the trial
    TO DEMONSTRATE SUPERIORITY OF A STRATEGY OF ANTICOAGULATION WITH APIXABAN 5 MG/2.5 MG BID AS COMPARED WITH THE CURRENT STANDARD OF CARE (DUAL ANTIPLATELET THERAPY) AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC) IN PATIENTS WITH ATRIAL FIBRILLATION
    TO DEMONSTRATE SUPERIORITY OF A STRATEGY OF ANTICOAGULATION WITH APIXABAN 5 MG/2.5 MG BID AS COMPARED WITH THE CURRENT STANDARD OF CARE (DUAL ANTIPLATELET THERAPY) AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC) IN PATIENTS WITH ATRIAL FIBRILLATION
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age> 18 years
    • NVAF (paroxysmal, persistent or permanent)
    • CHADS2 score ≥1 or CHA2DS2-VASc score ≥2
    * Adequate anatomy for LAA closure and contraindication for OAC (absolute or relative).
    • Able to give informed consent and to be followed-up (phone and clinical visit)
    • Edad> 18 años
    • FANV (paroxística, persistente o permanente)
    • Escala CHADS2 ≥ 1 o Escala CHA2DS2-VASc ≥ 2
    • Adecuada anatomía para cierre de orejuela izquierda LAA y contraindicación para ACO (absoluta o relativa)
    • Estar capacitado para dar el consentimiento informado y realizar los seguimientos telefónicos y las visitas clínicas.
    E.4Principal exclusion criteria
    • Patients with mechanical prostheses, evidence of thrombus, complex aortic atheroma or symptomatic carotid disease
    • Contraindication for TEE studies
    • Platelets <40000
    • Absolute contraindication to Apixaban for 3 months (severe renal failure with Cl. creat <15 ml / h or severe liver disease Child B or C) or allergy to the drug.
    Contraindication to any form of anticoagulation or antiplatelet therapy.
    • Patients with a history of drug or alcohol abuse, or psychosocial reasons that preclude the follow-up of the patient.
    •Women of childbearing potential (WOCB)
    • Pacientes con prótesis mecánicas, evidencia de trombo intracavitario, ateroma aórtico complicado o enfermedad carotídea sintomática
    • Contraindicación para la realización de eTE seriados
    • Plaquetas <40000
    • Contraindicación absoluta para el tratamiento con apixaban durante tres meses (insuficiencia renal severa con CICreat<10 ml/h o hepatopatía severa Child B o C) o alergia a algunos de los fármacos.
    • Contraindicación a cualquier forma de terapia anticoagulante o antiplaquetaria
    • Pacientes con historial de abuso de drogas o alcohol, o características psicológicas que impidan el seguimiento del paciente
    • Mujeres con potencial de quedarse embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    COMBINED OF EFFICACY (THROMBOEMBOLIC EVENTS PREVENTION AND DEVICE THROMBOIS) AND SAFETY (MAJOR BLEEDING INCIDENCE) AT 3 MONTHS WITH BOTH STRATEGIES.
    COMBINADO DE EFICACIA ( PARA LA PREVENCIÓN DE EVENTOS TROMBOEMBÓLICOS CLÍNICOS Y TROMBOSIS DE DISPOSITIVO) Y SEGURIDAD (PARA LA INCIDENCIA DE SANGRADOS MAYORES) A LOS TRES MESES ENTRE LAS DOS ESTRATEGIAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 MONTHS
    3 MESES
    E.5.2Secondary end point(s)
    12 MONTHS
    12 MESES
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MESES
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    THERAPEUTIC
    TERAPEUTICO
    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
    ASPIRINA Y CLOPIDOGREL
    AAS AND CLOPIDOGREL
    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 concerned3
    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
    LVSL
    ÚLTIMA VISITA DEL ÚLTIMO PACIENTE
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 136
    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 No
    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 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 state160
    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)
    Clinical follow-up will be performed at 1, 3, 6 and 12 months with a clinical visit and physical examination.
    At 3 and 12 months we will also collect general laboratory tests including hemoglobin, platelet count, coagulation status and renal function.
    Imaging follow-up will include serial TEE or CT scan 1, 3 and 12 months after the index procedure in order to increase the sensitivity of device thrombosis detection.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation HOSPITAL CLÍNIC BARCELONA - PHARMACY SERVICE
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation HOSPITAL CLÍNIC BARCELONA - CARDIOLOGY SERVICE
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
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