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    Summary
    EudraCT Number:2014-003064-21
    Sponsor's Protocol Code Number:AAS
    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:2014-09-22
    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 number2014-003064-21
    A.3Full title of the trial
    THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES
    USO DE LA ASPIRINA COMO PREVENCIÓN PRIMARIA EN PACIENTES CON DIABETES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES
    USO DE LA ASPIRINA COMO PREVENCIÓN PRIMARIA EN PACIENTES CON DIABETES
    A.3.2Name or abbreviated title of the trial where available
    ASPIRIN PROTOCOL
    PROTOCOLO ASPIRINA
    A.4.1Sponsor's protocol code numberAAS
    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 Universitari de Girona Dr. Josep Trueta
    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 supportHospital Universitari de Girona Dr.Josep Trueta
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Girona Dr. Josep Trueta
    B.5.2Functional name of contact pointCristina Martinez
    B.5.3 Address:
    B.5.3.1Street AddressAvda França s/n, Planta 9,desapcho 912
    B.5.3.2Town/ cityGirona
    B.5.3.3Post code17007
    B.5.3.4CountrySpain
    B.5.4Telephone number00349729402002343
    B.5.5Fax number0034972227443
    B.5.6E-mailcmartinez@idibgi.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.2.1.1.1Trade name ACYD ACETIL SALYCILIC
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS CINFA, S.A.
    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 nameacyd acetil salycilic
    D.3.4Pharmaceutical form Gastro-resistant 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 INNASPIRINE
    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 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.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
    cardiovascular prevention in patients diagnosed in diabetes mellitus
    prevención cardiovascular en pacientes con diabetes
    E.1.1.1Medical condition in easily understood language
    cardiovascular prevention in patients diagnosed in diabetes mellitus
    prevención cardiovascular en pacientes con diabetes
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10012602
    E.1.2Term Diabetes mellitus (incl subtypes)
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare platelet reactivity in different subgroups of diabetic population without prior vascular disease (such as diabetes 1 and type 2 diabetics) with and without metabolic syndrome criteria on what happens in the general healthy population.
    Comparar la reactividad plaquetaria en diferentes subgrupos de población diabética sin patología vascular previa (tan diabéticos tipo 1 como diabéticos tipo 2) con y sin criterios de síndrome metabólico respecto a lo que sucede en la población general sana.
    E.2.2Secondary objectives of the trial
    1. Define the phenotypic characteristics of individuals according to their platelet reactivity
    2.Compare the effectiveness of different treatment regimens with aspirin in these subgroups of patients versus the general healthy population.
    3. Assess endothelial dysfunction
    4. Assess the status/level of inflammation
    1. Definir las características fenotípicas de los individuos según la reactividad plaquetaria que presenten.
    2. Comparar la eficacia de diferentes pautas de tratamiento con aspirina en estos subgrupos de pacientes respecto a lo que sucede en la población general sana.
    3. Valorar la disfunción endotelial de los pacientes a estudio mediante parámetros de laboratorio.
    4. Valorar el grado de inflamación de los pacientes a estudio mediante parámetros de laboratorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria CASES:
    1. Patients of both sexes aged between 18 and 40.
    2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) diagnosed with type 1/2 diabetes for at least 1 year of evolution.
    3.patients with diabetes mellitus (as type 1 and type 2) who meet the criteria for metabolic syndrome defined as:
    - Central obesity (BMI> 30kg/m2) HIGH-LIMIT <39.9 kg/m2
    - Waist circumference (in Europe): Men> or => 94 cm and women> or => 80 cm
    - More than two of any of the following factors:
    o Increased triglycerides:> 150 mg / dl or specific treatment for this lipid abnormality.
    or decrease in HDL-C <40 mg / dl (men) or <50mg/dL (women) or specific treatment for this lipid abnormality.
    o Increased systolic blood pressure> 130 mmHg or diastolic> 85 mm Hg or specific treatment of previously diagnosed hypertension.
    o Increased blood glucose:
    ? fasting blood glucose> 100 mg / dl or
    ? previously diagnosed type 2 diabetes.
    4. Affects type 1/2 patients who met diagnostic criteria for NO metabolic syndrome (as defined in paragraph 3) diabetes.
    5. Signed informed consent priot to participation in the study.

    - Inclusion criteria CONTROLS:
    1. Patients of both sexes aged between 18 and 40.
    2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) fulfilling diagnostic criteria for metabolic syndrome that are NOT diabetic.
    3. Volunteers Healthy individuals without a diagnosis of diabetes or who meet diagnostic criteria for metabolic syndrome.
    4. Signed informed consent prior to participation in the study.
    Criterios de inclusión CASOS:
    1.Pacientes de ambos sexos con edad entre 18 y 40 años.
    2.Pacientes ambulatorios visitados regularmente en nuestro centro o pacientes ambulatorios del área de referencia de la Unidad de Diabetes Endocrinología y Nutrición Territorial de Girona (UDENTG) con diagnóstico de diabetes tipo 1/2 de al menos 1 año de evolución.
    3.Pacientes afectos de diabetes mellitus (tan tipo 1 como tipo 2) que cumplen los criterios que definen el síndrome metabólico como:
    - Obesidad central (IMC> 30kg/m2)-LÍMITE ALTO <39.9 kg/m2
    - Perímetro de la cintura (en europeos): Hombres> o => 94 cm y mujeres> o => 80 cm
    - Más de dos de cualquiera de los siguientes factores:
    o Aumento de los triglicéridos:> 150 mg / dl o tratamiento específico de esta alteración lipídica.
    o Disminución del cHDL <40 mg / dl (hombres) o <50mg/dl (mujeres) o tratamiento específico de esta alteración lipídica.
    o Aumento de la presión arterial sistólica> 130 mmHg o diastólica> 85 mm Hg o tratamiento específico de hipertensión diagnosticada previamente.
    o Incremento de la glucemia:
    ? glucemia en ayunas >100 mg/dl o bien
    ? diabetes tipo 2 diagnosticada previamente.
    4. Pacientes afectos de diabetes tipo 1 que NO cumplen criterios diagnósticos de síndrome metabólico (definidos en el apartado 3).
    5. Firma del consentimiento informado para la participación en el estudio.


    - Criterios de inclusión CONTROLES:
    1. Pacientes de ambos sexos con edad entre 18 y 40 años.
    2. Pacientes ambulatorios visitados regularmente en nuestro centro o pacientes ambulatorios del área de referencia de la Unidad de Diabetes Endocrinología y Nutrición Territorial de Girona (UDENTG) que cumplan criterios diagnósticos del síndrome metabólico que NO sean diabéticos.
    3. Individuos sanos voluntarios sin diagnóstico de diabetes ni que cumplan criterios diagnósticos de síndrome metabólico.
    4. Firma del consentimiento informado para la participación en el estudio.
    E.4Principal exclusion criteria
    1. History of previous cardiovascular disease, uncontrolled hypertension, ischemic or hemorrhagic gastrointestinal disease and asthma stroke.
    2. Severe systemic disease unrelated to diabetes and cancer, severe liver or renal disease.
    3. Previous use of chronic treatment with aspirin or any other antiplatelet drug (in the two weeks prior to baseline).
    4. Hematologic or coagulation Pathology.
    5. Hypersensitivity to aspirin.
    6. Treatment that could interact with AAS as acetazolamide, anticoagulants, antineoplastic agents, alcohol, antacids, corticosteroids, other NSAIDs, methotrexate, niacin, anticonvulsants, and antidepressants alendròmic acid.
    7. Recent vaccination (less than 2 months).
    8. Pregnancy and lactation.
    9. Persons released on legal or administrative requirement.
    10. Symptoms and clinical signs of infection in the month prior to recruitment.
    11. History of major psychiatric at the discretion of the investigator
    1. Antecedente de enfermedad cardiovascular previa, HTA no controlada, infarto cerebral isquémico o hemorrágico y patología digestiva y asma .
    2. Enfermedad sistémica grave no relacionada con la diabetes como cáncer, patología renal o hepática grave.
    3. Uso previo de tratamiento crónico con aspirina o cualquier otro fármaco antiagregante (en las dos semanas anteriores al inicio del estudio).
    4. Patología hematológica o de la coagulación.
    5. Hipersensibilidad al ácido acetilsalicílico.
    6.Toma de fármacos que interfierenn con la acción del AAS : acetazolazida , anticoagulantes, antineoplásicos, alcohol, antiácidos, corticoides, otros AINEs, metotrexato, niacina, anticonvulsivantes , ácido alendròmic y antidepresivos.
    7.Vacunación reciente (menos de 2 meses) .
    8.Embarazo y lactancia.
    9.Personas con libertad bajo requerimiento legal o administrativo.
    10.Síntomas y signos clínicos de infección en el mes anterior al reclutamiento.
    11.Antecedentes psiquiátricos de importancia a criterio del investigador
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of our study is the degree of antiplatelet therapy in different population groups.
    La variable principal de nuestro estudio es el grado de antiagregación plaquetaria en los diferentes grupos de población.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at day 0 and 7
    Antes del inicio y tras los 7 días de tratamiento
    E.5.2Secondary end point(s)
    Demographyc and clinical data
    Medical history
    cormobidities
    Concomitant medication
    Complete physical examination
    Blood sample
    Datos clínicos y demográficos
    Antecedenets patologicos
    Cormoibilidades
    Meidicación concomitante
    Examen físico compelto
    Analisis clínicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last day of study
    Ultimo dia del estudio
    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 No
    E.6.4Safety No
    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 Yes
    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 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 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
    Last visit of the clinical study
    Ultima visita del estudio
    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
    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: 180
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state180
    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)
    normal treatment
    tratamiento habitual
    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 Decision2015-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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