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    The EU Clinical Trials Register currently displays   38451   clinical trials with a EudraCT protocol, of which   6312   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005568-40
    Sponsor's Protocol Code Number:LoDoCo2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-005568-40
    A.3Full title of the trial
    Low-dose colchicine for secondary prevention of cardiovascular disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low-dose colchicine for prevention of cardiovascular disease after a cardiovascular event
    A.3.2Name or abbreviated title of the trial where available
    LoDoCo2
    A.4.1Sponsor's protocol code numberLoDoCo2
    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 SponsorWerkgroep Cardiologische centra Nederland
    B.1.3.4CountryNetherlands
    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 supportWithering Stichting Nederland; ZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWerkgroep Cardiologische centra Nederland
    B.5.2Functional name of contact pointChair WCN
    B.5.3 Address:
    B.5.3.1Street AddressMoreelsepark 1
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3511 EP
    B.5.3.4CountryNetherlands
    B.5.6E-mailsecretariaat@wcnnet.nl
    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 Colchicine 0,5 mg Tiofarma, tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderTiofarma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    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
    cardiovascular disease
    E.1.1.1Medical condition in easily understood language
    Patients with stable coronary artery disease
    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.1.3Condition 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 evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven revascularization.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of
    1. Myocardial infarction
    2. Ischemia-driven revascularization
    3. Cardiovascular death or myocardial infarction
    4. Cardiovascular death
    5. Death from any cause
    6. the composite of sudden cardiac death, non-fatal out of hospital cardiac arrest, myocardial infarction or unstable angina irrespective of revascularization, or atherosclerotic ischemic stroke (the composite endpoint of the first LoDoCo trial),
    7. the composite of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke,
    8. Acute coronary syndromes related to stent or graft disease, irrespective of revascularization


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study title:
    Coronary artery inflammation measured with 68Ga-DOTATATE PET/CT in patients with stable coronary artery disease treated with low-dose colchicine
    version 1.0, August 2017

    Primary Objective:
    The aim of this study is to identify differences in coronary artery wall inflammation as assessed with 68G-DOTATATE in patients with stable coronary artery disease after treatment with colchicine 0.5 mg once daily.


    Protocol v2.6 dated 26 July 2019 included two substudie. One biobanking substudies for 2000 participants at selected trial sites and one imaging substudy for 200 participants at selected trial sites.
    E.3Principal inclusion criteria
    1. Age >35 and <82 years
    2. Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score >400). Individuals with a history of bypass surgery are only eligible if they have undergone coronary artery bypass surgery more than 10 years before, or have angiographic evidence of graft failure or have undergone percutaneous intervention since their bypass surgery
    3. Clinically stable for at least six months
    E.4Principal exclusion criteria
    1. Women who are pregnant, breast feeding or may be considering pregnancy during the study period
    2. Renal impairment as evidenced by a serum creatinine >150 µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
    3. Severe heart failure – systolic or diastolic New York Heart Association Functional classification 3 or 4
    4. Moderate or severe valvular heart disease considered likely to require intervention
    5. Dependency or frailty or an estimated life expectancy < 5 years
    6. Peripheral neuritis, myositis or marked myo-sensitivity to statins
    7. Requirement for long term colchicine therapy for any other reason
    8. Current enrollment in another trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven revascularization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    75% and 100% of necessary endpoints
    E.5.2Secondary end point(s)
    The secondary objectives of this study are to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of
    1. Myocardial infarction
    2. Ischemia-driven revascularization
    3. Cardiovascular death or myocardial infarction
    4. Cardiovascular death
    5. Death from any cause
    6. the composite of sudden cardiac death, non-fatal out of hospital cardiac arrest, myocardial infarction or unstable angina irrespective of revascularization, or atherosclerotic ischemic stroke (the composite endpoint of the first LoDoCo trial),
    7. the composite of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke,
    8. Acute coronary syndromes related to stent or graft disease, irrespective of revascularization

    E.5.2.1Timepoint(s) of evaluation of this end point
    at 100% of the expected events
    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 No
    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 concerned40
    E.8.5The trial involves multiple Member States No
    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
    Canada
    Netherlands
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 4023
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2030
    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 state3580
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3580
    F.4.2.2In the whole clinical trial 5447
    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)
    This study is designed to study colchicine on top of the standard of care. After the trial the standard of care therapy will continue. If the study is positive the route to registration for colchicine for this indication will be started.
    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 Decision2016-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-17
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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