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    Summary
    EudraCT Number:2014-005172-28
    Sponsor's Protocol Code Number:MHIPS-003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005172-28
    A.3Full title of the trial
    COLCHICINE CARDIOVASCULAR OUTCOMES TRIAL (COLCOT)
    COLCHICINE CARDIOVASCULAR OUTCOMES TRIAL (COLCOT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COLCOT Study
    Studio COLCOT
    A.3.2Name or abbreviated title of the trial where available
    COLCOT
    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 codeH1Y3N1
    B.5.3.4CountryCanada
    B.5.4Telephone number00151446113002133
    B.5.5Fax number0015144611301
    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 nameColchicina
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Modified-release 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 INNCOLCHICINA
    D.3.9.1CAS number 64-86-8
    D.3.9.2Current sponsor code-
    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 number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboModified-release 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)
    Pazienti con malattia aterosclerotica coronarica
    E.1.1.1Medical condition in easily understood language
    Patient who have suffered a myocardial infarction
    Pazienti che hanno avuto un infarto miocardico
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10011082
    E.1.2Term Coronary artery disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10011085
    E.1.2Term Ischaemic coronary artery disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028595
    E.1.2Term Myocardial infarct
    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 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)
    L'obiettivo principale dello studio è di determinare se un trattamento a lungo termine con colchicina riduce la frequenza di eventi cardiovascolari in pazienti dopo un infarto miocardico.
    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
    L’obiettivo secondario è verificare il profilo di sicurezza di un trattamento a lungo termine con colchicina in questa tipologia di pazienti
    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
    Maschi e femmine di età =18 anni, in grado di fornire il consenso informato;
    IM nel corso degli ultimi 30 giorni; Trattamento in accordo alle linee guida nazionali (inclusi antiaggreganti piastrinici, statine, inibitori del sistema renina-angiotensina-aldosterone (preferibilmente angiotensin converting enzyme (ACE) inibitori) e beta bloccanti se indicati; Procedure di rivascolarizzazione miocardica dovute all’IM completate; Donne non in età fertile, definite come in menopausa da almeno un anno o sterili chirurgicamente, oppure donne in età fertile che facciano uso di almeno un metodo contraccettivo e preferibilmente due forme complementari di contraccezione comprendenti metodi di barriera (per esempio: profilttici maschili o femminili, spermicidi, spugne, schiuma spermicida, gel spermicida, diaframma, e dispositivi intrauterini (IUD)) durante lo studio e per i 30 giorni successivi alla fine dello studio
    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 type II index MI (secondary to ischemic imbalance); 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 parameters 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
    Pazienti in condizioni cliniche scadenti, come scompenso cardiaco in classe NYHA IV, una frazione di eiezione <35%, un recente ictus (negli ultimi 3 mesi), o qualsiasi altra condizione che, a giudizio dello sperimentatore, potrebbe mettere a rischio il paziente in caso di partecipazione allo studio; Pazienti con IM indice di tipo II secondario a ischemia dovuta ad uno squilibrio tra richiesta e offerta di ossigeno; Pazienti che hanno effettuato un by pass aortocoronarico nei 3 anni precedenti o che lo hanno programmato; Pazienti in shock cardiogeno o emodinamicamente instabili; Pazienti con storia di cancro o malattia linfoproliferativa negli ultimi 3 anni escluso i tumori cutanei squamo o basocellulari ed i carcinomi in situ del collo dell’utero trattati con successo; Pazienti con malattie infiammatorie intestinali (Crohn o colite ulcerosa) o pazienti con diarrea cronica; Pazienti con malattia neuromuscolare nota o con livelli di CPK > 3 volte il limite superiore di normalità riscontrati negli ultimi 30 giorni e ritenuti non transitori; Pazienti con una delle seguenti alterazioni riscontrate negli ultimi 30 giorni e ritenuti non transitori:
    Emoglobina <115g/L, Globuli bianchi <3.0x109/L, Piastrine <110x109/L, ALT > 3 volte il limite di normalità, Bilirubina totale> 2 volte il limite di normalità (è permessa la Sindrome di Gilbert), Creatinina> 2 volte il limite di normalità;
    Pazienti con storia di cirrosi epatica, epatite cronica attiva o disfunzione epatica grave;
    Donne in gravidanza o allattamento o che lo possono diventare nel corso dello studio o nei 6 mesi dopo l’ultima assunzione del farmaco;
    Pazienti con storia significativa di abuso di alcool o droga nel corso dell’ultimo anno;
    Pazienti che stanno attualmente utilizzando o prevedono di iniziare una terapia steroidea sistemica cronica (orale o endovenosa) durante lo studio (sono consentiti steroidi topici o inalatori);
    Pazienti che assumono colchicina per altre indicazioni (principalmente per motivi cronici quali gotta o febbre mediterranea familiare) Non è necessario un periodo di wash-out per i pazienti che sono stati trattati con colchicina e hanno interrotto il trattamento prima dell'arruolamento;
    Allergia o ipersensibilità alla colchicina;
    Uso di farmaci sperimentali negli ultimi 30 giorni o 5 emivite prima della visita di Screening (a seconda di quale è più lungo); Pazienti considerati dallo sperimentatore, per qualsiasi motivo, candidati inadatti per lo studio;
    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
    L’end point primario è il tempo dalla randomizzazione al primo evento di morte cardiovascolare, arresto cardiaco rianimato, IM acuto, stroke, ricovero urgente per angina che richiede rivascolarizzazione
    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% degli endpoint primari (analisi ad interim) 2) a fine studio
    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
    L'endpoint secondario è costituito dal tempo alla mortalità totale e ai componenti dell'endpoint primario e ad un combinato di morte cardiovascolare arresto cardiaco rianimato infarto miocardico acuto o stroke. Saranno anche valutati tutti gli eventi cardiovascolari.
    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% degli endpoint primari (analisi ad interim) 2) a fine studio
    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 Yes
    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 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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Argentina
    Brazil
    Canada
    Chile
    France
    Germany
    Italy
    Lebanon
    Poland
    Portugal
    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
    Event Driven
    Al raggiungimento di 301 eventi end point (si veda protocollo)
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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 state750
    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
    Non sono previsti programmi specifici
    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 Decision2016-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
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