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    Summary
    EudraCT Number:2014-001675-32
    Sponsor's Protocol Code Number:ARTE
    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:2014-07-22
    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 number2014-001675-32
    A.3Full title of the trial
    Aspirin versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation with the
    Edwards Valve. A Randomized Study (the ARTE trial).
    Estudio randomizado piloto de aspirina frente aspirina + clopidogrel como terapia antitrombótica tras el implante percutáneo de prótesis aórtica (IPPVA) con la válvula Edwards
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin and clopidogrel versus aspirin alone for the prevention of blood clots following transcatheter aortic valve Implantation.
    Aspirina y clopidogrel versus aspirina sola para la prevención de trombos tras la implantación de una valvula aórtica transcateter.
    A.3.2Name or abbreviated title of the trial where available
    ARTE
    ARTE
    A.4.1Sponsor's protocol code numberARTE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01559298
    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 SponsorIUCPQ
    B.1.3.4CountryCanada
    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 supportIUCPQ
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportEdwards Lifesciences SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinico San Carlos
    B.5.2Functional name of contact pointHemodinámica
    B.5.3 Address:
    B.5.3.1Street AddressPso Profesor Martin lagos s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number349133030003438
    B.5.5Fax number349133035153515
    B.5.6E-mailmelanie.cote@criucpq.ulaval.ca
    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 Clopidogrel
    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.3.4Pharmaceutical form
    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.3.9.3Other 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.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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HELLAS ABEE
    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
    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.3.9.3Other 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 typerange
    D.3.10.3Concentration number80 to 325
    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
    Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.
    Incidencia de muerte, infarto de miocardio, accidente cerebrovascular isquémico, ataque isquemico transitorio o riesgo para la salud y sangrado.
    E.1.1.1Medical condition in easily understood language
    Risk of death, heart attack, cerebrovascular accident or bleeding.
    Time Frame: 3-month follow-up after transcatheter aortic valve implantation.
    Incidencia de muerte, infarto de miocardio, accidente cerebrovascular isquémico, ataque isquemico transitorio o riesgo para la salud y sangrado.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10013118
    E.1.2Term Diseases of aortic valve
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic stroke) or death without increasing the risk of major bleeding events.
    Comparar la terapia antiagregante de aspirina + clopidogrel frente aspirina solo tras la IPPVA para la prevención de eventos isquémicos mayores (infarto e ictus isquémico) o muerte y el riesgo de eventos hemorrágicos mayores.
    E.2.2Secondary objectives of the trial
    Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.
    Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days
    Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up
    Incidence of MI or ischemic stroke at 30 days and at 12-month follow-up
    Incidence of major bleeding at 30 days and at 12-month follow-up
    Cardiovascular death at 30 days and at 12-month follow-up
    Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI
    Rate of minor bleeding at 30 days and at 12-month follow-up
    Incidencia de mortalidad, infarto de miocardio, ictus isquémico/accidente isquémico transitorio (AIT) o hemorragia mayor/amenazante para la vida durante los primeros 3 meses tras la intervención.
    Incidencia de muerte, infarto de miocardio, ictus isquémico/AIT, o hemorragia mayor/amenazante para la vida en los primeros 30 días.
    Incidencia de infarto de miocardio o ictus isquémico a 30 días y 1 año de seguimiento.
    Incidencia de hemorragia mayor a 30 días y 1 año de seguimiento.
    Muerte cardiovascular a 30 días y 1 año de seguimiento.
    Coste efectividad del clopidogrel asociado a la aspirina tras la IPPVA.
    Tasa de hemorragia menor a 30 días y 1 año de seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing a TAVI procedure with the Edwards valve.
    Pacientes sometidos a IPPVA con válvula Edwards (tanto por vía transfemoral, transapical u otros accesos).
    E.4Principal exclusion criteria
    -Need for chronic anticoagulation treatment
    -Major bleeding within the 3 months prior to the TAVI procedure
    -Prior intracranial bleeding
    -Drug-eluting stent implantation within the year prior to the TAVI procedure
    -Allergy to clopidogrel and/or aspirin/acetylsalicylic acid
    Necesidad de anticoagulación crónica.
    Hemorragia mayor en los 3 meses previos a la IPPVA
    Hemorragia intracraneal previa.
    Stent farmacoactivo en el último año previo al procedimiento.
    Alergia a la aspirina y/o clopidogrel
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding
    Incidencia de mortalidad, infarto de miocardio, ictus isquémico/accidente isquémico transitorio (AIT) o hemorragia mayor/amenazante para la vida
    E.5.1.1Timepoint(s) of evaluation of this end point
    3-month follow-up
    a los 3 meses
    E.5.2Secondary end point(s)
    -Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding
    -Incidence of MI or ischemic stroke
    -Incidence of major bleeding
    -Cardiovascular death
    -Cost-effectiveness of clopidogrel on top of aspirin following TAVI
    -Rate of minor bleeding
    Incidencia de muerte, infarto de miocardio, ictus isquémico/AIT, o hemorragia mayor/.
    Incidencia de hemorragia mayor
    Muerte cardiovascular
    Coste efectividad del clopidogrel asociado a la aspirina tras la IPPVA.
    Tasa de hemorragia menor
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 days and at 12-month follow-up
    Al mes y al año
    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 No
    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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Chile
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 300
    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
    no aplica
    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 Decision2014-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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