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    Summary
    EudraCT Number:2009-013713-99
    Sponsor's Protocol Code Number:2009.559
    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:2012-07-26
    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 number2009-013713-99
    A.3Full title of the trial
    Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients (CIRCUS study)
    ¿Mejora la ciclosporina la evolución en los pacientes con infarto agudo de miocardio con elevación del ST? (ensayo CIRCUS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients (CIRCUS study)
    ¿Mejora la ciclosporina la evolución en los pacientes con infarto agudo de miocardio con elevación del ST? (ensayo CIRCUS)
    A.3.2Name or abbreviated title of the trial where available
    CIRCUS
    A.4.1Sponsor's protocol code number2009.559
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportNeuroVive
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d?Hebron
    B.5.2Functional name of contact pointDavid Garcia-Dorado
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d?Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.6E-maildgdorado@vhebron.net
    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 No
    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 nameCicloMulsion
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion for infusion
    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
    acute myocardial infarction
    infarto agudo de miocardio
    E.1.1.1Medical condition in easily understood language
    acute myocardial infarction
    infarto agudo de miocardio
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to determine whether Cyclosporine A, administered immediately prior to PCI reperfusion improves clinical outcomes in AMI patients
    El objetivo del presente estudio es determinar si la ciclosporina A puede mejorar el resultado clínico de los pacientes con IAMEST.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    - to determine whether cyclosporine A, administered immediately prior to PCI reperfusion has an effect on:
    1) Mortality events following AMI (at 30 days and 1 year)
    2) Cardiac and vascular events following AMI
    3) Cardiac prognostic factors

    - to describe the tolerance of medicinal investigational products.
    Determinar si la administración intracoronaria de ciclosporina A antes de la reperfusión tiene efecto sobre
    1) la mortalidad post IAM (a los 30 días y 1 año)
    2) eventos cardíacos y vasculares post IAM
    3) factores de prognóstico cardíaco.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The principal investigators of each of these sub-studies will have to develop a specific sub-study protocol and submit it first to approval to the Steering Committee, and afterwards to approval of local authorities and the IEC (independent ethic committee).
    The main sub-studies that were already submitted and approved by the Steering Committee are listed below:

    1/ study of adiponectin (Principal Investigator: Dr. Marc Claeys, belgium)
    Adiponectin will be measured in an estimated number of 256 patients in the control group in order to assess relation between adiponectin levels and occurrence of reperfusion injury. Comparisons will be made between an estimated 64 patients in the low quartile of adiponectin vs. the others, as well as interaction with the study treatment. This sub-study will be linked to the bio-bank.

    2/ MRI substudy
    Assessment of the effect of cyclosporine treatment of infarct size and microvascular obstruction (MVO: no reflow) by MRI.

    3/ cyclophilin D (Principal Investigator: Dr. Michel Ovize, France)
    Objective: to determine whether circulating cypD may be a marker that may predict infarct size. This sub-study will be linked to the bio-bank

    4/ genetic association study
    Centralised genetic samples will be collected in an ancillary study.
    E.3Principal inclusion criteria
    1. All (male and female) patients, aged over 18, without any legal protection measure
    2. Having a health coverage
    3. Presenting within 12 hours of the onset of chest pain,
    4. Who have ST segment elevation > 0.2 mV in two contiguous leads,
    5. For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
    And (further inclusion criteria to be confirmed by the admission coronary-angiography)
    6. The culprit coronary artery has to be the LAD
    7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
    8. Preliminary oral informed consent followed by signed informed consent as soon as possible.
    Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
    Pacientes (mujeres y hombres), mayores de 18 años, con cobertura médica, que se presenten en las primeras 12 horas tras el inicio de dolor torácico y con elevación de ST > 0.2 mV en dos derivaciones consecutivas y que sean tratados con angioplastia.
    La arteria coronaria responsable debe ser la descendente anterior (DA) y debe estar ocluida (TIMI 0-1) en el momento de realizar la primera inyección angiográfica. Tanto los pacientes que reciban angioplastia primaria como de rescate se pueden incluir en el estudio
    E.4Principal exclusion criteria
    1. Patients with loss of consciousness or confused
    2. Patients with cardiogenic shock
    3. Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region
    4. Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
    5. Patients with
    - known hypersensitivity to cyclosporine
    - known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
    - known liver insufficiency
    - uncontrolled (treated or untreated) hypertension (> 180/110 mmHg)
    6. Patients treated with
    - any compound containing Hypericum perforatum (St.-John?s-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
    - an active treatment that might modify blood concentration of Cyclosporine (diltiazem, vérapamil?)
    7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
    8. Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation
    - cancer, lymphoma
    - known positive serology for HIV, or hepatitis
    Pacientes con pérdida de conocimiento o confusos. Pacientes en situación de shock cardiogénico; pacients cuya arteria responsable sea Circunfleja (CF) o derecha (CD) o que presenten evidencia de circulación colateral en la zona de riesgo, arteria responsable abierta (TIMI > 1 en DA en la primera inyección angiográfica); pacientes con hipersensibilidad conocida a la Ciclosporina A, huevo, frutos secos, proteínas de soja, o con insuficiencia renal conocida (aclaramiento de creatinina documentado previamente < 30 ml/min/1.73m² o que reciben atención médica por insuficiencia renal severa, insuficiencia hepática conocida, hipertensión no controlado (> 180/110 mmHg), tratada o sin tratar; pacientes tratados con cualquier compuesto que contenga Hypericum perforatum ( Hierba de San Juan ) o Estiripentol o Aliskiren o Bosentan o Rosuvastatina o con un tratamiento activo que puede modificar la concentración en sangre de Ciclosporina A ( diltiazem , verapamilo?); mujeres embarazadas o en edad fértil que no usen métodos anticonceptivos; Pacientes con cualquier alteración del sistema inmunitario en los 6 meses previos al inicio del estudio: cáncer, linfoma, serología positiva para VIH o hepatitis.
    E.5 End points
    E.5.1Primary end point(s)
    Combined incidence of [total mortality; hospitalization for heart failure; LV remodelling (increase of LV end-diastolic volume >15%)] at one year post-AMI
    Incidencia combinada de [mortalidad total, hospitalización por insuficiencia cardíaca, remodelado ventricular (aumento del volumen telediastólico vetricular izquierdo >15%)] al cabo de año del IAMEST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year post AMI
    un año post-IAM
    E.5.2Secondary end point(s)
    - Mortality events :
    1. All causes of mortality
    2. Cardiovascular deaths

    - Cardiac and vascular events :
    1. Heart failure: 1) in-hospital worsening of heart failure after reperfusion, 2) re-hospitalization for: a) worsening of a heart failure existing at admission, b) appearance of ?new? heart failure
    2. Myocardial infarction
    3. Unstable angina
    4. Stroke
    5. LV remodelling

    - Cardiac prognostic factors :
    1. Infarct size: peak Troponin (T or I)
    2. LV function at one year
    3. Microvascular obstruction (no reflow)

    - Tolerance to medicinal investigational products
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 30 days and 1 year for mortality events
    - 1 year for other end points
    Valorados a los 12 meses.
    1) mortalidad total,
    2) mortalidad de causa cardiovascular,
    -Eventos cardíacos y vasculares [empeoramiento de la insuficiencia cardiaca después de la reperfusión durante el ingreso, o re-hospitalización por: 1) empeoramiento de la insuficiencia cardiaca ya presente en el momento del ingreso, 2) nueva aparición de la insuficiencia cardiaca]
    2)infarto de miocardio,
    3)angina inestable,
    4)Accidente vascular cerebral (AVC)
    5)remodelado ventricular
    Factores de interés pronóstico cardíaco:
    1. Tamaño del infarto: Pico de troponinas (To I)
    2. Función Ventrículo Izquierdo a un año
    3. Obstrucción microvascular (No reflow)
    Tolerancia a los productos medicos investigados
    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.8.2.4Number 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 Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Last patient's last visit
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    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 months6
    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: 972
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 972
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with a condition which makes them incapable of giving written consent personally and who need urgent care
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 972
    F.4.2.2In the whole clinical trial 972
    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)
    Nothing different from the expected normal treatment of that 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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-28
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    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
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