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:2004-000120-32
    Sponsor's Protocol Code Number:P03684
    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:2010-04-15
    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 number2004-000120-32
    A.3Full title of the trial
    "Inhibición precoz de la glucoproteina IIb/IIIa en el síndrome coronario agudo sin elevación del segmento ST: ensayo aleatorizado y controlado con placebo para evaluar los efectos clínicos beneficiosos de eptifibátida precoz con carga anterior en el tratamiento de pacientes con síndrome coronario agudo sin elevación del segmento ST". (EARLY ACS).

    "Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome". (EARLY ACS)
    A.3.2Name or abbreviated title of the trial where available
    EARLY ACS
    A.4.1Sponsor's protocol code numberP03684
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorSchering-Plough Research Institute
    B.1.3.4CountryUnited States
    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 Integrilin 0.75 mg/ml Solución para perfusión.
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIntegrilin 0.75 mg/ml solución para perfusión
    D.3.4Pharmaceutical form Solution for infusion
    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 INNeptifibatide
    D.3.9.2Current sponsor codeSCH 60936
    D.3.9.3Other descriptive nameIntegrilin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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 Integrilin 2 mg/ml Solución para perfusión.
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIntegrilin 2 mg/ml solución para perfusión.
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeptifibatide
    D.3.9.2Current sponsor codeSCH 60936
    D.3.9.3Other descriptive nameIntegrilin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pacientes que presentan síndrome coronario agudo de alto riesgo sin elevación del segmento ST y en los que está previsto el tratamiento con una técnica invasora no antes del día siguiente a la aleatorización.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    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 de este estudio es demostrar la superioridad de eptifibátida precoz, administrada como embolada doble más infusión, comparada con placebo (con uso provisional de eptifibátida en el laboratorio de cateterismo) en cuanto a la reducción de la combinación de muerte, infarto de miocardio (IM), isquemia recurrente que requiere revascularización urgente (IR-RU) y obstrucción vascular (bail-out) trombótica (OVT) en las 96 horas posteriores a la aleatorización en pacientes con síndrome coronario agudo sin elevación del segmento ST (SCA SEST) de alto riesgo en los que está previsto el tratamiento con una técnica invasora no antes del día siguiente a la aleatorización.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son demostrar la superioridad del uso precoz de eptifibátida en comparación con placebo (con uso provisional de eptifibátida en el laboratorio de cateterismo) en este ámbito, en cuanto a la reducción de:

    - La combinación de muerte e IM en el plazo de 30 días
    - La combinación de muerte, IM e IR-RU en el plazo de 30 días
    - La combinación de muerte e IM en el plazo de 96 horas
    - La aparición de MI en el plazo de 96 horas
    - La aparición de muerte en el plazo de 30 días

    Además, se evaluará la aparición de muerte en el plazo de 6 meses y 1 año.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 años o más.
    2. Disposición y capacidad para otorgar el consentimiento informado. El paciente debe ser capaz de cumplir los procedimientos del estudio y el seguimiento durante 1 año.
    3. Presencia de síntomas de isquemia cardíaca en reposo (angina o equivalente anginoso) con episodios de una duración mínima de 10 minutos en el plazo de 24 horas desde la aleatorización, y al menos 2 de las características siguientes:
    - Cambios en el electrocardiograma: descenso del segmento ST nuevo o presumiblemente nuevo ≥ 0,1 mV (≥ 1mm) o ascenso transitorio (< 30 minutos del segmento ST ≥ 0,1 mV (≥ 1mm) al menos en 2 desviaciones contiguas.
    - Aumento en los niveles de troponina I o T por encima de los criterios establecidos en cada centro o nivel de la fracción MB de creatina cinasa (CK-MB) mayor que el límite superior de normalidad (LSN) del centro.
    - 60 años o más.
    O presentar los 3 siguientes:
    - Antecedentes de enfermedad cardiovascular (ej: previo IM, PCI, DAC, >50% estenosis arterial coronaria por angiografía, isquemia presente en es estudio de estrés físico o estrés farmacológico, enfermedad vascular periférica [PVD] con síntomas y evidencia objetiva [ej: índice de la presión braquial del tobillo {ABI}≤0.9], CVA no hemorrágica).
    - Aumento en los niveles de troponina I o T por encima de los criterios establecidos en cada centro o nivel de la fracción MB de creatina cinasa (CK-MB) mayor que el límite superior de normalidad (LSN) del centro.
    - 50-59 años.
    4. Posibilidad de aleatorización en el plazo de 12 horas desde la presentación.
    5. Previsión de ser sometido a una técnica invasora después de la administración del medicamento en estudio durante 12 a 96 horas.
    E.4Principal exclusion criteria
    1. Embarazo presunto o confirmado; las mujeres postmenopáusicas deben contar con un resultado negarivo confirmado en una prueba de embarazo en orina o suero antes de su inclusión en el estudio.
    2. Diálisis renal en los 30 días previos a la aleatorización.
    3. Otra enfermedad grave (p.ej. cáncer activo en los últimos 5 años, septicemia) o cualquier trastorno que el investigador considere que supondría un riesgo significativo para el paciente si se iniciara el tratamiento en investigación.
    4. Antecedentes de ictus hemorrágico en cualquier momento o de ictus no hemorrágico de cualquier etiología en los 7 días anteriores, lesión estructural del sistema nervioso central (SNC) (p.ej. neoplasia, aneurisma, cirujía intracraneal); cualquier traumatismo craneoencefálico o facial grave reciente.
    5. Antecedentes de diátesis hemorrágica, incluida hemorragia digestiva documentada o cualquier antecedente de hemorragia digestiva clínicamente significativa o datos de una hemorragia anormal activa en el plazo de 30 días antes de la aleatorización o un cociente internacional normalizado (CIN) >1,8 debido al tratamiento con un anticoagulante oral o una coagulopatía subyacente.
    6. Cirujía mayor, biópsia de un órgano parenquimatoso o traumatismo significativo en el plazo de 14 días antes de la aleatorización.
    7. Antecedentes de trombocitopenia inducida por heparina o eptifibátida o un recuento de plaquetas < 100.000/mm3. El recuento de plaquetas debe confirmarse extrayendo una muestra de sangre.
    8. Intención de utilizar un inhibidor directo de la protrombina (p.ej. bivalirudina [Angiomax®]), inhibidor del factor Xa (p.ej. fondaparinux [Arixtra®]), o cualquier otro anticoagulante diferente a HNF o heparinas de bajo peso molecular de acuerdo a las tratamientos habituales locales. (Excepción: se permite la administración de warfarina tras completar la infusión del fármaco del estudio a los pacientes que precisen anticoagulantes orales.)
    9. Tratamiento reciente con un inhibidor de la GP IIb/IIIa; abciximab en el plazo de 24 horas antes de la aleatorización, o eptifibátida, tirofibán u otro fármaco en el plazo de 4 horas antes de la aleatorización.
    10. Hipersensibilidad conocida a cualquier componente de los productos evaluados en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Seguridad: Se vigilarán todos los acontecimientos adversos graves (AAG) desde la aleatorización hasta el contacto de seguimiento que se efectuará a los 30 días. Además, se evaluarán los episodios clínicos y dos variables de seguridad importantes (en los pacientes sometidos a DAC): volumen de sangrado postoperatorio y necesidad de reexploración quirúrgica. La mortalidad se vigilará durante el año siguiete a la aleatorización.

    Eficacia: El criterio de vali¡oración principal de la eficacia es la combinación de muerte, IR-RU y TBO en el plazo de 96 horas. El criterio de valoración secundario clave de la eficacia es la combinación de muerte e IM en el plazo de 30 días. Todos los componentes de los criterios de valoración de la eficacia, excepto la muerte, serán valorados por un Comité de Episodios Clínicos.
    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 Yes
    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 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.8.5The trial involves multiple Member States Yes
    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
    1 año después de la llamada telefónica de seguimiento realizada al último paciente.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 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 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 state225
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 9500
    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)
    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 Decision2005-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-18
    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-Thu Apr 25 17:02:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA