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    Summary
    EudraCT Number:2006-002292-40
    Sponsor's Protocol Code Number:CV-149-16
    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:2006-06-08
    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 number2006-002292-40
    A.3Full title of the trial
    Análisis proteómico del plasma y plaquetas de pacientes con Diabetes tipo II con enfermedad arterial coronaria estabilizada. Modificación por el tratamiento con clopidogrel. Estudio piloto.
    A.3.2Name or abbreviated title of the trial where available
    CID
    A.4.1Sponsor's protocol code numberCV-149-16
    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 SponsorFundación para la Investigación y Desarrollo en el Área Cardiovascular (FIC)
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name ISCOVER
    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 nameIscover
    D.3.2Product code SR25990
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Diabetes Mellitus Tipo II con enfermedad coronaria estabilizada
    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
    Objetivo principal: Evaluar el efecto de una dosis diaria de 75 mg de clopidogrel sobre la expresión de proteínas asociadas con la activación plaquetaria en pacientes con diabetes mellitus tipo II con enfermedad coronaria estabilizada que reciben tratamiento de base que incluye AAS a dosis bajas.
    E.2.2Secondary objectives of the trial
    Objetivos secundarios:· Determinar si el tratamiento con AAS (Acido acetil salicilico) o una combinación de clopidogrel + AAS (Acido acetil salicilico) podría modificar el proteoma de las plaquetas.· Analizar si el tratamiento con clopidogrel favorece que las plaquetas de los pacientes diabéticos con isquemia miocárdica establecida sean más inactivas que las plaquetas de los pacientes tratados con AAS (Acido acetil salicilico).· Debido a que tanto el proteoma plasmático como el plaquetario no están completamente identificados, tanto las proteínas detectadas así como aquellas que resulten de interés científico debido a algún cambio inesperado, serán estudiadas mediante un segundo análisis por espectrometría de masas.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Sujetos con edad > 45 años y que cumplan todos los siguientes criterios:
    1. Pacientes con diabetes tipo II.
    2. HbA1c ≤10 % obtenida en el momento de la selección o durante las 4 semanas previas.
    3. 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.
    4. Historia de enfermedad arterial coronaria documentada definida como estenosis > 50% en ≥ 1 arteria coronaria principal, clínicamente estable durante al menos 6 meses.
    5. Pacientes que reciban hasta AAS 162 mg/día como tratamiento antiplaquetario durante al menos 3 meses.
    El paciente debe estar capacitado para dar su consentimiento informado que se obtendrá en la visita de selección, antes de iniciar cualquier procedimiento relacionado con el estudio. Tras su firma, se le entregará al paciente una fotocopia del mismo.
    E.4Principal exclusion criteria
    1) Mujeres en edad fértil que no utilizan un método anticonceptivo eficaz.
    2) Mujeres en estado de gestación o período de lactancia.
    3) 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.
    4) Diabetes tipo 2 sintomática con marcada poliuria y polidipsia con una pérdida de peso superior al 10% durante los últimos 3 meses.
    5) 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 6 meses.
    6) Revascularización coronaria en los 6 meses previos.

    Historia Médica previa:
    1) Presencia de enfermedades infecciosas o enfermedad tumoral.
    2) Pacientes con riesgo elevado de sangrado como insuficiencia hepática severa, úlcera péptica, retinopatía diabética proliferativa, historia de hemorragia sistémica grave ( ej: hemorragia gastrointestinal, hematuria grave, hemorragia intraocular, hemorragia intracraneal o ictus hemorrágico) en los últimos seis meses, u otra historia de diátesis hemorrágica o coagulopatía.
    3) Hipertensión no controlada definida como presión sistólica > 180 mmHg o presión diastólica > 110 mmHg en los tres meses previos a la inclusión en el estudio.
    4) Haber sufrido un trauma o proceso quirúrgico reciente (< 4 semanas), RCP prolongada (> 10 min).
    5) Procedimientos quirúrgicos programados durante el período de estudio.

    Variables de laboratorio:
    1) Insuficiencia hepática grave definida con valores de AST y/o ALT > 3x LSN y /o bilirrubina sérica total >2x LSN obtenido en el momento de inclusión o durante las 4 semanas previas a la inclusión en el estudio.
    2) Creatinina sérica > 1,5 mg/dl obtenida en el momento de inclusión o durante las 4 semanas previas a la inclusión en el estudio.
    3) Historia previa de trombocitopenia clínicamente significativa o persistente.
    4) Historia previa de neutropenia clínicamente significativa o persistente.
    5) HbA1c > 10% % obtenida en el momento de inclusión o durante las 4 semanas previas a la inclusión en el estudio.

    Alergia y reacciones adversas:
    1) Sensibilidad o contraindicación para el uso de AAS (Acido acetil salicilico) o clopidogrel o a componentes relacionados.

    Medicación/ terapia concomitante:
    1) Uso de anticoagulantes orales o dipiridamol o tienopiridinas (ticlopidina o clopidogrel)
    2) Tratamiento con clopidogrel o ticlopidina durante las dos semanas previas a la inclusión en el estudio.
    3) Uso de fármacos antiinflamatorios, fármacos anti-COX-2 o corticosteroides durante las dos semanas previas a la inclusión en el estudio.
    4) Uso de drogas inmunosupresoras durante el pasado año.

    Otros criterios de exclusión:
    1) Factores geográficos o sociales que en opinión del investigador hagan poco práctica la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    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
    Grupo Control
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    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 Decision2006-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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