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    Summary
    EudraCT Number:2014-002142-50
    Sponsor's Protocol Code Number:POPCABG03
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-11-19
    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 number2014-002142-50
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery.
    Een gerandomiseerd, dubbel-blind, placebo-gecontroleerd onderzoek naar het effect van ticagrelor op de doorgankelijkheid van veneuze omleidingen in patiënten die coronaire bypass chirurgie ondergaan.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery.
    Een gerandomiseerd, dubbel-blind, placebo-gecontroleerd onderzoek naar het effect van ticagrelor op de doorgankelijkheid van veneuze omleidingen in patiënten die coronaire bypass chirurgie ondergaan.
    A.3.2Name or abbreviated title of the trial where available
    POPular CABG
    POPular CABG
    A.4.1Sponsor's protocol code numberPOPCABG03
    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 SponsorSt. Antonius Hospital
    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 supportAstraZeneca
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportStichting St. Antonius Hartennzorg
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Antonius Hospital
    B.5.2Functional name of contact pointDienstsein Plaatjesfunctiegroep
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310883209679
    B.5.6E-mailcardiologie-onderzoek@antoniusziekenhuis.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 Brillique
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral 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
    Coronary artery bypass grafting surgery with the use of one or more saphenous vein grafts.
    Coronaire bypass operatie met gebruik van een of meerdere venengrafts.
    E.1.1.1Medical condition in easily understood language
    Coronary artery bypass grafting surgery with the use of one or more saphenous vein grafts.
    Coronaire bypass operatie met gebruik van een of meerdere venengrafts.
    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
    To test the hypothesis that a combination of ticagrelor 90mg twice daily and acetylsalicylic acid 80mg once daily is superior to acetylsalicylic acid 80mg once daily alone in reducing the rate of saphenous vein graft occlusion in patients who underwent coronary artery bypass grafting with use of one or more saphenous vein grafts, as assessed with coronary computed tomography angiography at 1 year after randomization
    Het testen van de hypothese dat een combinatie van ticagrelor 90mg tweemaal daags en acetylsalicylzuur 80mg eenmaal daags superieur is ten opzichte van alleen acetylsalicylzuur 80mg eenmaal daags in het reduceren van veneuze graft occlusie in patiënten die een coronaire bypass operatie hebben ondergaan met gebruik van een of meerdere veneuze grafts, zoals beoordeeld met coronaire computed tomography angiografie 1 jaar na randomisatie
    E.2.2Secondary objectives of the trial
    To test the hypothesis that a combination of ticagrelor 90mg twice daily and ASA 80mg once daily is superior to ASA 80mg once daily alone in:
    • reducing the incidence of SVG failure at 1 year
    • reducing the rates of significant SVG stenosis, arterial graft occlusion, and significant arterial graft stenosis as assessed with CCTA at 1 year

    To describe the rate of bleeding events in patients in the intervention and control group:
    • the rate of Bleeding Academic Research Consortium (BARC) minor (type 1 or 2) and major (type 3, 4 or 5) bleeding at 30 days and 1 year
    • the rate of TIMI minimal, minor and major bleeding at 30 days and 1 year
    • the rate of PLATO minimal, minor and major bleeding at 30 days and 1 year

    To determine the value and optimal timing of platelet function tests in predicting thrombotice events.

    To determine in how many patients and for what reason the antiplatelet drugs or study drug are prematurely discontinued or switched to other antiplatelet drugs.
    Testen of een combinatie van ticagrelor 90mg tweemaal daags en ASA 80mg eenmaal daags superieur is ten opzichte van ASA 80mg eenmaal daags in:
    • reduceren van de incidentie van SVG failure op 1 jaar
    • reduceren van de incidentie van significante SVG stenose, arteriële graft occlusie en significante arteriële graft stenose zoals beoordeeld met CCTA op 1 jaar

    Beschrijven van bloedingen bij patiënten in de interventie- en controlegroep:
    • incidentie van Bleeding Academic Research Consortium (BARC) minor (type 1 or 2) en major (type 3, 4 or 5) bloedingen op 30 dagen en 1 jaar
    • incidentie van TIMI minimal, minor en major bloedingen op 30 dagen en 1 jaar
    • incidentie van PLATO minimal, minor en major bloedingen op 30 dagen en 1 jaar

    De waarde en optimale timing van plaatjesfunctietesten bepalen in het voorspellen van thrombotische events

    Bepalen in hoeveel patiënten en om welke reden plaatjesremmende medicatie of studiemedicatie vroegtijdig gestopt of geswitcht wordt
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: The GDF-15 substudy
    Date: 04-08-2014
    Version: 4.0
    Objectives:
    To determine if GDF-15 levels are influenced by the performance of a CABG procedure (substudy).
    To determine if GDF-15 levels can independently predict the occurrence of SVG occlusion, SVG failure, significant SVG stenosis, arterial graft occlusion, and significant arterial graft stenosis at 1 year after CABG in both treatment groups and for the entire study population (substudy).
    Titel: The GDF-15 substudy
    Datum: 04-08-2014
    Versie: 4.0
    Doelen:
    Bepalen of GDF-15 levels beïnvloedt worden door het uitvoeren van een coronaire bypassoperatie (substudie).
    Bepalen of GDF-15 levels onafhankelijk het optreden van veneuze graft occlusie, veneuze graft falen, significante veneuze graft stenose, arteriële graft occlusie en significante arteriële graft stenose op 1 jaar na CABG kunnen voorspellen in beide behandelgroepen en in de totale studiepopulatie (substudie).
    E.3Principal inclusion criteria
    1) More than 21 years of age
    2) Planned CABG with the use of 1 or more SVGs
    1) Meer dan 21 jaar oud
    2) Geplande CABG met gebruik van 1 of meer veneuze grafts
    E.4Principal exclusion criteria
    1) Unable to give informed consent or a life expectancy of less than 1 year

    2) Concomitant valve (excluding aortic valve bioprothesis), aorta or rhythm surgery during the same session

    3) Inability to undergo CCTA, in the investigator’s opinion, for instance due to severe claustrophobia or contrast allergy

    4) Use of oral anticoagulants (acenocoumarol, fenprocoumon, NOACs) and a contraindication for discontinuation of this medication or the expectation that the patient will have an indication for the use of these drugs after surgery

    5) Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG

    6) Use of other antiplatelet drugs than ASA (clopidogrel, prasugrel, ticagrelor, dypiridamol, etc.) and a contraindication for discontinuation of this medication after CABG, according to the treating physician or the investigator

    7) Women who are known to be pregnant, who have given birth within the past 90 days or who are breastfeeding

    8) Pre-menopausal women without adequate contraception

    9) Severe renal function impairment requiring dialysis

    10) Moderate or severe hepatic impairment

    11) Active malignancy with increase in bleeding risk, in the investigator’s opinion

    12) Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, claritromycin, nefazodone, ritonavir, atazanavir)

    13) Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator’s opinion.

    14) Contraindication for the use of ticagrelor or ASA (i.e. history of intracranial bleeding, high bleeding risk, previous allergic reaction), in the investigator’s opinion

    15) Previous randomization in this study
    1) Niet mogelijk om informed consentte geven of een levensverwachting minder dan 1 jaar

    2) Gelijktijdige klep- (met uizondering van biologische aortakleppen), aorta- of ritmechirurgie

    3) Niet mogelijk om CCTA te ondergaan volgens de onderzoeker bijv. door ernstige claustrofobie of contrastallergie

    4) Gebruik van orale anticoagulantia (acenocoumarol, fenprocoumon, NOACs) en een contra-indicatie voor stoppen van deze medicatie of de verwachting dat de patiënt een indicatie voor deze medicatie zal hebben na chirurgie

    5) Plaatsing van een drug-eluting stent in een coronair of hersenarterie in de 6 maanden voor CABG of plaatsing van een bare-metal stent in een coronair of hersenarterie inde maand voor CABG

    6) Gebruik van andere plaatjesremmende medicatie dan acetylsalicylzuur (clopidogrel, prasugrel, ticagrelor, dypiridamol, etc.) en een contra-indicatie voor het stoppen van deze medicatie na de CABG volgens de behandeld arts of de onderzoeker

    7) Vrouwen waarvan bekend is dat zij zwanger zijn, vrouwen die de afgelopen 90 dagen bevallen hebben of die borstvoeding geven

    8) Pre-menopausale vrouwen zonder adequate vorm van anticonceptie

    9) Ernstige nierfunctiestoornissen waarvoor dialyse nodig is

    10) Matige of ernstige leverfunctiestoornissen

    11) Actieve maligniteit met verhoogd bloedingsrisico volgens de onderzoeker

    12) Gebruik van sterke inhibitoren van CYP3A4 (e.g. ketaconazole, claritromycin, nefazodone, ritonavir, atazanavir)

    13) Thrombocytengetal of hemoglobine dat bij screening klinisch significant afwijkend is volgens de onderzoeker

    14) Contra-indicatie voor het gebruik van ticagrelor of acetylsalicylzuur volgens de onderzoeker (bijv. intracraniële bloeding in de voorgeschiedenis, hoog bloedingsrisico, eerdere allergische reactie)

    15) Eerder randomisatie binnen deze studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the SVG occlusion rate at 1 year after randomization as assessed with CCTA.
    Het primaire eindpunt is de rate van veneuze graft occlusie op 1 jaar na randomisatie zoals beoordeeld met CCTA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 1 year after randomization.
    Op 1 jaar na randomisatie.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoint is SVG failure at 1 year after randomization.

    Secondary endpoints are significant SVG stenosis, arterial graft occlusion, and significant arterial graft stenosis as assessed with CCTA at 1 year after randomization, and combinations of these endpoints.

    Secondary safety endpoint is BARC minor (type 1 or 2) and major (type 3, 4 and 5) bleeding at 30 days and 1 year after randomization.

    Secondary safety endpoint is TIMI minimal, minor and major bleeding at 30 days and 1 year after randomization.

    Secondary safety endpoint is PLATO minimal, minor and major bleeding at 30 days and 1 year after randomization.

    Secondary endpoint is the level of platelet reactivity, as assessed with platelet function tests pre-operative and 3 days and 1 year after randomization.

    Secondary endpoint is high on treatment platelet reactivity as assessed with different platelet function tests pre-operative and 3 days and 1 year after randomization.

    Secondary endpoint is the level of GDF-15, as assessed pre-operatively and 3 days and 1 year after randomization (substudy).

    Secondary endpoint is the premature discontinuation of antiplatelet drugs or the study drug and the switch of antiplatelet drugs or the study drug to other antiplatelet drugs during the study period and the reason for these decisions.
    Secundair efficacy eindpunt is "SVG failure" op 1 jaar na randomisatie.

    Secundair eindpunten zijn significante veneuze graft stenose, arterële graft occlusie en significante arteriële graft stenose zoals beoordeeld met CCTA op 1 jaar na randomisatie en combinaties van deze eindpunten.

    Secundair veiligheidseindpunt is BARC minor (type 1 or 2) en major (type 3, 4 and 5) bloeding op 30 dagen en 1 jaar na randomisatie.

    Secundair veiligheidseindpunt is TIMI minimal, minor en major bloeding op 30 dagen en 1 jaar na randomisatie.

    Secundair veiligheidseindpunt is PLATO minimal, minor en major bloeding op 30 dagen en 1 jaar na randomisatie.

    Secundair eindpunt is het niveau van plaatjesreactiviteit zoals beoordeeld met plaatjesfunctietesten pre-operatief en 3 dagen en 1 jaar na randomisatie.

    Secundair eindpunt is "high on treatment platelet reactivity" zoals beoordeeld met verschillende plaatjesfunctietesten pre-operatief en 3 dagen en 1 jaar na randomisatie.

    Secundair eindpunt is het niveau van GDF-15 zoals pre-operatief en 3 dagen en 1 jaar na randomisatie gemeten (substudy).

    Secundair eindpunt is het prematuur stoppen van plaatjesremmende medicatie of studiemedicatie en het switchen van plaatjesremmende medicatie of studiemedicatie naar andere plaatjesremmende medicatie gedurende de studieperiode en de reden hiervoor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As indicated under E5.2, most endpoints are assessed up to 1 year after randomization.
    Zoals beschreven bij E5.2 worden de meeste eindpunten tot 1 jaar na randomisatie beoordeeld.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned4
    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 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
    LVLS
    Laatste visite van de laatst geïncludeerde studiepatiënt
    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 months0
    E.8.9.1In the Member State concerned 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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state720
    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
    None
    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 Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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