Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-002747-16
    Sponsor's Protocol Code Number:AR1108888
    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:2008-09-30
    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 number2008-002747-16
    A.3Full title of the trial
    FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes (FUTURA)

    A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with UA/NSTEMI initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)


    Ensayo con fondaparinux y HNF durante la revascularización de síndromes coronarios agudos (FondaparinUx Trial with UHF during Revascularization in Acute Coronary Syndromes; FUTURA)

    Estudio prospectivo para evaluar la seguridad de dos pautas de heparina no fraccionada como tratamiento coadyuvante, durante la intervención coronaria percutánea en pacientes de alto riesgo con angina inestable/infarto de miocardio sin elevación del segmento ST, inicialmente tratados con Fondaparinux subcutáneo y remitidos para realización de angiografía coronaria precoz (OASIS 8).
    A.3.2Name or abbreviated title of the trial where available
    OASIS 8 (FUTURA)
    A.4.1Sponsor's protocol code numberAR1108888
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline SA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Arixtra 2.5 mg Injection
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFondaparinux sodium
    D.3.9.1CAS number 114870-03-0
    D.3.9.2Current sponsor codeGSK576428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg/ml
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Heparin Sodium Injection, ADD-Vantage Vial, 2000 USP Units per mL.
    D.2.1.1.2Name of the Marketing Authorisation holderHospira, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHeparin sodium
    D.3.9.1CAS number 9041-08-1
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Tratamiento de la angina inestable/infarto de miocardio sin elevación de ST
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.2Term Non ST segment elevation myocardial infarction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad de dos pautas de tratamiento de heparina no fraccionada intravenosa (HNF i.v.) como tratamiento adyuvante (dosis baja y dosis convencional) durante la intervención coronaria percutánea (ICP) de pacientes de alto riesgo con angina inestable/infarto de miocardio sin elevación del segmento ST (AI/IMSEST) nicialmente tratados con fondaparinux s.c. y remitidos para angiografía coronaria precoz.
    E.2.2Secondary objectives of the trial
    Evaluar el beneficio clínico neto de dos regímenes posológicos de HNF i.v. como tratamiento adyuvante (dosis baja y dosis convencional) durante la ICP de pacientes de alto riesgo con AI/IMSEST inicialmente tratados con fondaparinux subcutáneo y remitidos para angiografía coronaria precoz.

    Evaluar los resultados de eficacia relativa de dos regímenes de HNF i.v. como tratamiento adyuvante (dosis baja y dosis convencional) durante la ICP de pacientes de alto riesgo con AI/IMSEST inicialmente tratados con fondaparinux subcutáneo y remitidos para angiografía coronaria precoz.

    Evaluar si el sangrado y las complicaciones relacionadas con la intervención coronaria percutánea asociados a la HNF i.v. como tratamiento adyuvante durante la ICP en pacientes con AI/IMSEST tratados inicialmente con fondaparinux subcutáneo son comparables a los observados en el estudio OASIS 5, donde fondaparinux fue el único anticoagulante empleado durante la ICP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.- Estudio para comparar la estrategia de revascularización únicamente del vaso responsable versus la estrategia de revascularización completa mediante intervención coronaria percutánea (ICP), en pacientes con síndromes coronarios agudos sin elevación de ST (SCASEST)

    Objetivos:
    Determinar si la estrategia de revascularización completa mediante ICP es mejor que la ICP exclusiva del vaso responsable, en el sentido de reducir la tasa de muerte, reinfarto o isquemia refractaria al cabo de un año.


    2.- Estudio de coagulación

    Objetivos:

    -Examinar la asociación entre la intensidad de la coagulación durante el tratamiento con fondaparinux y el riesgo de infarto de miocardio, ictus o muerte.

    -Examinar la asociación entre la intensidad de la coagulación durante el tratamiento con fondaparinux y el riesgo de sangrado.

    -Examinar la asociación entre la inhibición de la activación por contacto y el riesgo de trombosis por catéter.
    E.3Principal inclusion criteria
    Los sujetos elegibles para el reclutamiento en el estudio de cohortes deberán cumplir todos estos criterios:

    Presentación o admisión en el hospital con síntomas sospechosos de AI o IMSEST, es decir, historia clínica compatible con dolor torácico característico de reciente comienzo o de naturaleza progresiva o síntomas isquémicos que aparezcan en reposo con una actividad mínima (duración mayor de 5 minutos o necesidad de nitroglicerina por vía sublingual para aliviar el dolor).

    Posibilidad de reclutamiento en las primeras 48 horas desde el inicio del episodio más reciente de síntomas.

    Angiografía coronaria planificada, con ICP si está indicado, dentro de las 72 horas después de la inclusión en el estudio cuando sea posible.

    Al menos, dos de los tres criterios adicionales siguientes:

    •Edad mayor o igual de 60 años
    •Troponina T o I o CK-MB por encima del límite superior normal
    •Cambios ECG compatibles con isquemia, es decir, depresión de ST de al menos 1 mm en 2 derivaciones contiguas o inversión de la onda T > 3 mm o cualquier desviación dinámica del segmento ST o elevación pasajera de ST.

    Consentimiento informado firmado y fechado.
    E.4Principal exclusion criteria
    Los sujetos que cumplan cualquiera de los siguientes criterios no podrán ser incluidos en el estudio:

    Menor de 21 años

    Cualquier contraindicación para la administración de HNF o de fondaparinux

    Contraindicación para la angiografía o la ICP en condiciones basales

    Necesidad urgente (<120 minutos) de angiografía coronaria debido a estos motivos:
    • angina refractaria o recurrente asociada a desviación dinámica de ST
    • insuficiencia cardíaca
    • arritmias potencialmente mortales
    • inestabilidad hemodinámica

    Sujetos que ya reciban tratamiento con enoxaparina (u otra HBPM), bivalirudina o HNF para tratar los eventos índice, salvo que la última dosis (i.v. o s.c.) se haya administrado:
    - ≥ 8 horas en el caso de HBPM
    - ≥60 minutos en el de bivalirudina
    - ≥90 minutos en el de HNF

    Ictus hemorrágico en los últimos 12 meses.

    Indicación para la anticoagulación distinta del SCA durante la hospitalización.

    Embarazo o mujer en edad fértil que no siga un método anticonceptivo eficaz.

    Enfermedad asociada con esperanzas de vida inferiores a 6 meses.

    Administración actual de un fármaco en fase de experimentación.

    Intervención revascularizadora ya aplicada al evento índice.

    Insuficiencia renal grave (es decir, aclaramiento estimado de creatinina <20 ml/min)
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal establecida es:

    Combinación de sangrado mayor, sangrado menor o complicaciones importantes de la vía de acceso vascular en el período peri-ICP*

    * El período peri-ICP se define como el comprendido entre la aleatorización y las 48 horas siguientes a la ICP.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    UFH low dose
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The trial will end when the last subject enrolled in the trial has completed their final visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1190
    F.4.2.2In the whole clinical trial 2000
    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 Decision2008-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-11
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 00:45:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA