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    The EU Clinical Trials Register currently displays   43857   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).

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    Summary
    EudraCT Number:2006-003622-29
    Sponsor's Protocol Code Number:BAY e 4465/ IMPACT 12198
    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:2007-07-05
    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 number2006-003622-29
    A.3Full title of the trial
    Estudio ARRIVE (Aspirin to Reduce Risk of Initial Vascular Events, aspirina para reducir el riesgo de accidentes vasculares iniciales) – Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico y de grupos paralelos para evaluar la eficacia (reducción de los acontecimientos de enfermedad cardiovascular) y la seguridad de 100 mg ácido de acetilsalicílico con recubrimiento entérico en pacientes con riesgo moderado de sufrir enfermedad cardiovascular.
    A.3.2Name or abbreviated title of the trial where available
    ARRIVE
    A.4.1Sponsor's protocol code numberBAY e 4465/ IMPACT 12198
    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 SponsorBayer HealhCare AG
    B.1.3.4CountrySwitzerland
    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 Aspirina con recubrimiento entérico, 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namecomprimidos de 100 mg de ácido acetilsalicílico con recubrimiento entérico
    D.3.4Pharmaceutical form Film-coated 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 INNacido acetilsalicilico
    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) 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pacientes con riesgo moderado de sufrir acontecimientos importantes de CI (riesgo a los 10 años: 10% al 20%; riesgo de ECV a los 10 años: aproximadamente 20% al 30%).

    Código de clasificación del MedDRA :
    Versión, Nivel, Código, Término:
    9.1, LLT, 10028596, Infarto de miocardio
    9.1 LLT, 10042244, Infarto
    9.1, PT, 10049993, Fallo cardiaco
    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: El principal objetivo de este estudio es evaluar los efectos clínicos de una dosis de 100 mg/día de ácido acetilsalicílico con recubrimiento entérico en comparación con placebo en la reducción de los acontecimientos de ECV en pacientes con riesgo moderado de sufrir acontecimientos importantes de CI (riesgo a los 10 años: 10% al 20%; riesgo de ECV a los 10 años: aproximadamente 20% al 30%).
    E.2.2Secondary objectives of the trial
    El objetivo secundario es evaluar la seguridad y la tolerabilidad de la dosis de 100 mg/día de ácido acetilsalicílico con recubrimiento entérico en comparación con placebo en la misma población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Edad
    • Elevación del colesterol
    • Fumador en la actualidad
    • Colesterol HDL bajo (HDL<40 mg/dl; medido en la selección).
    • Elevación de la presión arterial (PAS>140 mm Hg, medida en la selección).
    • En tratamiento con cualquier antihipertensivo en la actualidad.
    • Antecedentes familiares positivos de CI precoz
    E.4Principal exclusion criteria
    • Antecedentes clínicos de ECV, IAM, ictus, angioplastia o implantación de endoprótesis vascular en las coronarias, injerto de derivación de la arteria coronaria, arritmias de interés o insuficiencia cardiaca congestiva.
    • Pacientes con diabetes de tipo I o II que reciben tratamiento activo con fármacos).
    • Mujeres en período de lactancia o en edad fértil.
    • Esofagitis por reflujo, conocida o diagnosticada.
    • Alteración moderada de la función renal, según el juicio clínico del investigador.
    • Enfermedad o lesión hepática intensa, según el juicio clínico del investigador.
    • Antecedentes de asma inducida por la administración de salicilatos o sustancias con acción similar, sobre todo los AINE.
    • Indicación clara para el tratamiento con ácido acetilsalicílico, con otros antiplaquetarios o con anticoagulantes, en opinión del médico.
    • Uso crónico y frecuente (> 5 días/mes) de AINE, de inhibidores de la COX 2 o de metamizol (se podrá utilizar paracetamol y otros analgésicos no AINE).
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de la eficacia será una variable compuesta, y consistirá en el primer episodio de muerte de origen cardiovascular, IAM o ictus.
    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 Yes
    E.6.3Therapy Information not present in EudraCT
    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) 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned100
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA400
    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
    El estudio se llevará a cabo de forma dirigida y terminará cuando 1488 pacientes hayan alcanzado la variable principal de eficacia o cuando todos los pacientes hayan completado al menos 5 años de seguimiento, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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 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 state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10000
    F.4.2.2In the whole clinical trial 12000
    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 Decision2007-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-15
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