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   43873   clinical trials with a EudraCT protocol, of which   7292   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:2011-000619-16
    Sponsor's Protocol Code Number:EC10-060
    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:2011-11-02
    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 number2011-000619-16
    A.3Full title of the trial
    Identification of the effect of allopurinol treatment on platelets from diabetic patients with stable coronary ischemic disease and aspirin resistance. XUE Study.

    Estudio cruzado para valorar el efecto sobre las plaquetas del tratamiento con Alopurinol en pacientes diabéticos con enfermedad isquémica establecida y resistencia plaquetaria a la Aspirina: Estudio XUE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio para valorar el efecto sobre las plaquetas del tratamiento con Alopurinol en pacientes diabéticos
    A.3.2Name or abbreviated title of the trial where available
    XUE
    A.4.1Sponsor's protocol code numberEC10-060
    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 SponsorFundación Investigación Biomedica. Hospital Clinico San Carlos
    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 supportFundación Investigación Biomedica. Hospital Clinico San Carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Investigación Biomedica. Hospital Clinico San Carlos
    B.5.2Functional name of contact pointFundación Investigación Biomedica
    B.5.3 Address:
    B.5.3.1Street AddressProf Martin Lagos
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913303793
    B.5.5Fax number+34913303515
    B.5.6E-mailfuinvest.hcsc@salud.madrid.org
    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.2.1.2Country 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 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 INNALOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.3Other descriptive nameALLOPURINOL
    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.2.1.2Country 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 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 INNALOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.3Other descriptive nameALLOPURINOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.2.1.2Country 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 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 INNALOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.3Other descriptive nameALLOPURINOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Hipótesis: el tratamiento con alopurinol (600 mg/día) en pacientes diabéticos resistentes a aspirina con enfermedad coronaria establecida podría favorecer el efecto antiplaquetario de la aspirina e inducir cambios en el perfil de expresión proteico de estas células

    Hypothesis: treatment with allopurinol (600 mg/day) in diabetic patients resistant to aspirin with established coronary disease could enhance the antiplatelet effect of aspirin and induce changes in its protein expression profile
    E.1.1.1Medical condition in easily understood language
    El tratamiento con el fármaco alopurinol en pacientes diabéticos podría favorecer el efecto de la aspirina al producir cambios en las plaquetas (células de la sangre)
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    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
    El objetivo principal del presente estudio es analizar, en pacientes diabéticos con enfermedad coronaria establecida de más de un año de evolución resistentes a la acción antiplaquetaria de la aspirina, si el tratamiento con alopurinol favorece el efecto antiplaquetario de la aspirina desde el punto de vista de su funcionalidad. Para ello, se analizará al inicio y al final del tratamiento con alopurinol la funcionalidad de las plaquetas de estos pacientes mediante el Sistema PFA-100.

    The main objective of this study is to analyze, in diabetic patients with established coronary heart disease over a year of evolution resistant to aspirin's antiplatelet action, whether treatment with allopurinol favors the antiplatelet effect of aspirin from the point of view functionality. To do this, an analysis at the beginning and end of treatment with allopurinol the functionality of platelets in these patients using the PFA-100 system
    E.2.2Secondary objectives of the trial
    -Analizar el efecto del alopurinol sobre el mapa de expresión proteico plaquetario en pacientes diabéticos con enfermedad coronaria establecida resistentes a la aspirina
    -Determinar si el alopurinol modifica el secretoma de las plaquetas obtenidas de los pacientes incluidos en el estudio
    -Analizar si el tratamiento con alopurinol modifica el sistema NO/GMP cíclico en las plaquetas de los pacientes incluidos en el estudio
    -Analizar a nivel sistémico si el alopurinol ejerce efectos anti-inflamatorios beneficiosos para el paciente

    -To analyzethe effect of allopurinol on the platelet proteome in diabetic patients with stable coronary ischemic disease that are resistant to aspirin
    -To determine whether allopurinol modifies the platelet secretome of the included patients
    -To analyze whether allopurinol modifies the NO/cGMP system in platelets from the included patients
    -To analyze whether allopurinol exerts beneficial systemic anti-inflammatory effects in the studied patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pacientes con diabetes tipo II.
    -Pacientes con valores de PFA-100 ? 193 segundos.
    -HbA1c ?10 % obtenida en el momento de la selección o durante las 4 semanas previas.
    -AST/ALT < LSN (límite superior de la normalidad) x 3 obtenido en el momento de la visita de selección de pacientes o durante las 4 semanas previas.
    -Aclaramiento de creatinina >30 ml/min (MDRD)
    -Historia de enfermedad arterial coronaria documentada definida como estenosis > 50% en ? 1 arteria coronaria principal, clínicamente estable durante al menos 1 año.
    -Pacientes que reciban hasta 162 mg/día de AAS como tratamiento antiplaquetario durante al menos 12 meses y haber tomado la última dosis al menos 24 horas antes de su inclusión en el estudio.
    -Firma del consentimiento informado

    -Patients with type II diabetes.
    -Patients with values of PFA-100 ? 193 seconds.
    -HbA1c ? 10% obtained at the time of selection or during the previous 4 weeks.
    -AST/ALT <ULN (upper limit of normality) x 3 obtained when the patient screening visit or during the previous 4 weeks.
    -Creatinine clearance> 30 ml / min (MDRD)
    -History of documented coronary artery disease defined as> 50% stenosis in ? 1 major coronary artery, clinically stable for at least 1 year.
    -Patients who received up to 162 mg / day of aspirin as antiplatelet therapy for at least 12 months after the last dose at least 24 hours before inclusion in the study.
    -Signed informed consent
    E.4Principal exclusion criteria
    -Pacientes con valores de PFA-100 > 193 segundos.
    -Diabetes tipo 2 sintomática con marcada poliuria y polidipsia con una pérdida de peso superior al 10% durante los últimos 3 meses.
    -Aclaramiento de creatinina <30 ml/min (MDRD)
    -Enfermedad coronaria sintomática con al menos un episodio de dolor coronario típico y alteración del segmento ST y/o cambio en las enzimas cardiacas en los últimos 12 meses.
    -Revascularización coronaria en los 12 meses previos.
    -Pacientes que hayan recibido o estén recibiendo otros tratamientos antitrombóticos además de la aspirina en el mes previo.
    -Pacientes con enfermedad infecciosa, inflamatoria, o neoplásica conocidas.
    -Pacientes que hayan recibido cualquier tratamiento antiinflamatorio en el último mes, u otras medicaciones fuera de las propias utilizadas para su enfermedad coronaria.
    -Uso de drogas inmunosupresoras durante los últimos 12 meses.
    -Procedimientos quirúrgicos programados durante el período de estudio
    -Mujeres en estado de gestación o período de lactancia.
    -Mujeres que en el momento de inclusión en el estudio o bien justo antes del momento de la administración de los fármacos den positivo al test de embarazo.
    -Pacientes que no firmen el consentimiento informado

    -Patients with PFA-100 values> 193 seconds.
    -Symptomatic type 2 diabetes with marked polyuria and polydipsia with weight loss exceeding 10% during the last 3 months.
    -Creatinine clearance < 30 ml /min (MDRD)
    -Symptomatic coronary disease with at least one episode of pain and impaired coronary typical ST segment and / or cardiac enzyme changes in the last 12 months.
    -Coronary revascularization in the previous 12 months.
    -Patients who have received or are receiving other antithrombotic treatments in addition to aspirin in the previous month.
    -Patients with infectious disease, inflammatory, or neoplastic known.
    -Patients who have received any anti-inflammatory therapy in the last month, or other medications out of their own used for coronary artery disease.
    -Use of immunosuppressive drugs during the past 12 months.
    -Surgical procedures scheduled during the study period
    -Pregnant women or breastfeeding.
    -Women who at the time of inclusion in the study or just before the time of administration of drugs have a positive pregnancy test.
    -Patients who do not sign the informed consent
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el estudio de los posibles cambios en la funcionalidad plaquetaria tras el tratamiento con dosis altas de alopurinol mediante el empleo del sistema PFA-100.

    The main end point is the study of possible changes in platelet function after treatment with high doses of allopurinol by the use of the PFA-100 system.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A las 6 semanas de tratamiento con alopurinol

    After 6 weeks with allopurinol treatment
    E.5.2Secondary end point(s)
    Variables secundarias
    -Análisis de los cambios plasmáticos inducidos en diferentes marcadores inflamatorios tras el tratamiento con alopurinol (Proteína C reactiva de alta sensibilidad, IL-6,IL-10,IL-8,IL-12).
    -Análisis de los cambios inducidos en el proteoma plaquetario tras el tratamiento con dosis altas de alopurinol.
    -Análisis de los cambios inducidos en las proteínas liberadas al medio por las plaquetas (secretoma) tras el tratamiento con dosis altas de alopurinol.
    -Análisis del sistema NO/GMPC plaquetario en las plaquetas resistentes a aspirina antes y después del tratamiento con alopurinol.


    Secondary end points
    -Analysis of plasma changes induced in various inflammatory markers following treatment with allopurinol (Protein C reactive protein, IL-6, IL-10, IL-8, IL-12).
    -Analysis of induced changes in the platelet proteome after treatment with high doses of allopurinol.
    -Analysis of induced changes in proteins released into the medium by platelets (secretome) after treatment with high doses of allopurinol.
    -Analysis of the NO / platelet GMPC in platelets resistant to aspirin before and after treatment with allopurinol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A las 6 semanas de tratamiento con alopurinol

    After 6 weeks with allopurinol treatment
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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
    no tratamiento
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Se considerará que el ensayo ha finalizado una vez que el último paciente incluido en el estudio realice la última visita.
    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 years3
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 2011-11-02. 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 state68
    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)
    Los pacientes seguirán con su tratamiento médico habitual

    Patients will follow standard treatment for their clinical condition

    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Mon May 06 15:52:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA