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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2014-005172-28
    Sponsor's Protocol Code Number:MHIPS-003
    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:2017-10-20
    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 number2014-005172-28
    A.3Full title of the trial
    Colchicine Cardiovascular Outcomes Trial (COLCOT)
    ESTUDIO DE COLCHICINA EN EVENTOS CARDIOVASCULARES (COLCOT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Colchicine Cardiovascular Outcomes Trial
    Ensayo de resultados cardiovasculares de colchicina
    A.3.2Name or abbreviated title of the trial where available
    COLCOT
    A.4.1Sponsor's protocol code numberMHIPS-003
    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 SponsorMontreal Heart Institute
    B.1.3.4CountryCanada
    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 supportMontreal Heart Institute
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMontreal Health Innovations Coordinating Center, a division of Montreal Heart Institute
    B.5.2Functional name of contact pointMylene Provencher
    B.5.3 Address:
    B.5.3.1Street Address4100 Molson, suite 400
    B.5.3.2Town/ cityMontreal/Quebec
    B.5.3.3Post codeH1Y 3N1
    B.5.3.4CountryCanada
    B.5.4Telephone number514461-13002133
    B.5.5Fax number514461-1301
    B.5.6E-mailmylene.provencher@mhicc.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 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 namecolchicine
    D.3.4Pharmaceutical form Coated 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 INNCOLCHICINE
    D.3.9.1CAS number 64-86-8
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboCoated 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
    patients with atherosclerotic coronary artery disease (CAD)
    pacientes con enfermedad arterial coronaria aterosclerótica
    E.1.1.1Medical condition in easily understood language
    patient who have suffered a myocardial infarction
    paciente que ha sufrido un infarto de miocardio
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary objective of this study is to determine whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction (MI)
    El objetivo primario de este estudio es determinar si el tratamiento a largo plazo con colchicina reduce las tasas de eventos cardiovasculares en pacientes luego de un infarto de miocardio (IM).
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine the safety of long-term treatment with colchicine in this patient population.
    El objetivo secundario es determinar la seguridad del tratamiento a largo plazo con colchicina en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females, at least 18 years of age , capable and willing to provide informed
    consent;
     Patient must have suffered a documented acute MI within the last 30 days;
     Patient must be treated according to national guidelines (including anti-platelet therapy,
    statin, renin-angiotensin-aldosterone system (RAAS) inhibitor (preferably angiotensinconverting-
    enzyme (ACE) inhibitor) and beta-blocker when indicated);
     Patient must have completed any planned percutaneous revascularization procedures
    associated with his/her qualifying MI;
     Female patient is either not of childbearing potential, defined as postmenopausal for at
    least 1 year or surgically sterile, or is of childbearing potential and practicing at least one
    method of contraception and preferably two complementary forms of contraception
    including a barrier method (e.g. male or female condoms, spermicides, sponges, foams,
    jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after
    study completion;
    Patient is judged to be in good general health as determined by the principal investigator;
     Patient must be able and willing to comply with the requirements of this study protocol
    Hombres y mujeres, de al menos 18 años de edad, capaces y dispuestos a dar su consentimiento informado;
     El paciente debe haber experimentado un infarto agudo de miocardio documentado dentro de los últimos 30 días;
     El paciente debe estar recibiendo tratamiento de acuerdo a las guías nacionales (incluyendo terapia antiplaquetaria, estatinas, un inhibidor del sistema renina-angiotensina-aldosterona (SRAA), (preferentemente un inhibidor de la enzima convertidora de angiotensina (IECA) ) y betabloqueantes cuando estén indicados;
     El paciente debe haber completado cualquier procedimiento planeado de revascularización percutánea, relacionado con el infarto de miocardio calificante;
     Paciente de sexo femenino no fértil, lo que se define como posmenopáusica por al menos 1 año o esterilizada quirúrgicamente, o mujer en edad fértil que esté utilizando al menos un método anticonceptivo y preferentemente dos métodos complementarios de anticoncepción, incluyendo un método de barrera (por ejemplo: preservativos masculinos o femeninos, espermicidas, esponjas, espumas o geles anticonceptivos, diafragmas , dispositivo intrauterino (DIU)) a lo largo de todo el estudio y hasta 30 días después de la finalización del mismo;
     Paciente con buen estado general de salud según la evaluación del investigador principal;
     El paciente debe ser capaz y estar dispuesto a cumplir con los requerimientos del protocolo del estudio.
    E.4Principal exclusion criteria
    Patient with a poorly controlled medical condition, such as New York Heart Association
    Class III-IV heart failure, a left ventricular ejection fraction of less than 35%, recent
    stroke (within the past 3 months), or any other condition which, in the opinion of the
    investigator, would put the patient at risk if participating in the study
    Patient with a prior coronary artery bypass graft within the past 3 years, or planned;
     Patient currently in cardiogenic shock or with hemodynamic instability;
     Patient with a history of cancer or lymphoproliferative disease within the last 3 years,
    other than a successfully treated non-metastatic cutaneous squamous cell or basal cell
    carcinoma and/or localized carcinoma in situ of the cervix;
     Patient with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or patient
    with chronic diarrhea;
     Patient with pre-existent progressive neuromuscular disease or patient with CPK level > 3
    times the upper limit of normal (unless due to MI, which is allowed) as measured within
    the past 30 days and determined to be non-transient through repeat testing
    Patient with any of the following as measured within the past 30 days, and determined to
    be non-transient through repeat testing:
    - hemoglobin < 115g/L,
    - white blood cell count < 3.0 X 109/L,
    - platelet count <110 X 109/L,
    - ALT > 3 times the upper limit of normal (ULN),
    - total bilirubin > 2 times ULN (unless due to Gilbert syndrome, which is
    allowed)
    - Creatinine > 2 times ULN;
     Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
     Female patient who is pregnant, or breast-feeding or is considering becoming pregnant
    during the study or for 6 months after the last dose of study medication;
     Patient with a history of clinically significant drug or alcohol abuse in the last year;
     Patient is currently using or plans to begin chronic systemic steroid therapy (oral or
    intravenous) during the study (topical or inhaled steroids are allowed);
     Patient currently taking colchicine for other indications (mainly chronic indications
    represented by Familial Mediterranean Fever or gout). There is no wash-out period
    required for patients who have been treated with colchicine and stopped treatment prior
    to enrolment;
    Patient with a history of an allergic reaction or significant sensitivity to colchicine;
     Patient who has used an investigational chemical agent less than 30 days or 5 half-lives
    prior to the Screening visit (whichever is longer);
     Patient is considered by the investigator, for any reason, to be an unsuitable candidate for
    the study.
    Pacientes con una condición médica no controlada, como por ejemplo una insuficiencia cardíaca Clase III-IV de la NYHA, una fracción de eyección ventricular izquierda inferior al 35%, un accidente cerebrovascular reciente (dentro de los últimos 3 meses), o cualquier otra condición que a criterio del investigador pueda poner en riesgo al paciente si participa en el estudio;
     Pacientes con una cirugía de revascularización miocárdica previa realizada dentro de los últimos 3 años o programada;
     Paciente en actual estado de shock cardiogénico o con inestabilidad hemodinámica;
     Paciente con antecedentes de cáncer o enfermedad linfoproliferativa dentro de los últimos 3 años, que no sean carcinomas de células escamosas cutáneas no metastásicas tratadas con éxito, o carcinoma de células basales, y/o carcinomas in situ localizados en el cuello uterino;
     Paciente con enfermedad inflamatoria intestinal (enfermedad de Crohn o colitis ulcerosa) o paciente con diarrea crónica;
     Paciente con enfermedad neuromuscular progresiva preexistente o paciente con niveles de CPK 3 veces más alto que el límite mayor normal (a menos que se deba al IM, lo que está permitido), según medición realizada en los últimos 30 días y donde se haya determinado mediante la repetición de las pruebas que no son valores transitorios;
     Paciente con cualquiera de los siguientes valores determinados dentro de los últimos 30 días, y que se haya comprobado que no son valores transitorios mediante la repetición de las pruebas:
    - hemoglobina < 115g/L,
    - recuento de glóbulos blancos < 3,0 X 109/L,
    - recuento de plaquetas <110 X 109/L,
    - GPT > 3 veces el límite mayor normal (LMN),
    - Bilirrubina total > 2 veces el LMN (a menos que se deba al síndrome de Gilbert, lo que está permitido);
    - Creatinina> 2 veces el LMN;
     Pacientes con antecedentes de cirrosis, hepatitis crónica activa o enfermedad hepática severa;
     Paciente de sexo femenino cursando embarazo o en período de lactancia, o que está planeando un embarazo durante el estudio o en los 6 meses luego de la última dosis de la medicación del estudio;
     Paciente con antecedentes de abuso de drogas o alcohol, clínicamente significativosen el último año;
    Paciente que se encuentre realizando o planee realizar un tratamiento crónico con esteroides sistémicos (vía oral o intravenosa) durante el estudio (los corticoides tópicos o inhalados están permitidos);
     Paciente que se encuentre tomando colchicina para otras indicaciones (principalmente prescripciones crónicas para fiebre familiar del mediterráneo o gota). No se requerirá período de lavado de droga para pacientes que hayan sido tratados con colchicina y hayan dejado el tratamiento antes del enrolamiento.
     Pacientes con antecedentes de reacciones alérgicas o sensibilidad significativa a la colchicina;
     Paciente que haya utilizado algún agente químico en investigación dentro de los últimos 30 días o 5 vidas medias previos a la visita de Selección (el que sea mayor);
     Paciente que el investigador considere por cualquier motivo, que es un candidato inapropiado para el estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the time from randomization to the first event of cardiovascular death, resuscitated cardiac arrest, acute MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.
    La variable principal será el tiempo desde la aleatorización hasta el primero de los siguientes eventos: muerte cardiovascular, paro cardiaco resucitado, infarto agudo de miocardio, accidente cerebrovascular (ACV), u hospitalización de urgencia por angina que requiera revascularización coronaria
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) at 50% of primary endpoints ( interim analysis)
    2) at end of the study
    1) al 50% de la variable principal (análisis intermedio)
    2) al final del estudio
    E.5.2Secondary end point(s)
    The secondary endpoints will consist of times to total mortality to components of the primary endpoint, and to the composite of cardiovascular death, resuscitated cardiac arrest, acute MI, or stroke. Recurrent cardiovascular events will also be evaluated.
    Las variables secundarias consistirán en el tiempo hasta la mortalidad total, de los componentes de la variable principal y hasta el evento combinado compuesto por mortalidad cardiovascular, paro cardiaco resucitado, infarto agudo de miocardio o ACV. Eventos cardiovasculares recurrentes también serán evaluados
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at 50% of primary endpoints ( interim analysis)
    2) at end of the study
    1) al 50% de la variable principal (análisis intermedio)
    2) al final del estudio
    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 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Italy
    Lebanon
    Portugal
    Spain
    Tunisia
    United Kingdom
    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
    Since it is an event driven trial LVLS will be performed after obtaining 301 events.
    Como es un ensayo dirigido por eventos, la última visita del último paciente será realizada después de obtener 301 eventos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 3500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 4500
    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)
    None
    Ninguno.
    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 Decision2018-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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