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    Summary
    EudraCT Number:2016-002586-64
    Sponsor's Protocol Code Number:ISS13616
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-23
    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 ConcernedGreece - EOF
    A.2EudraCT number2016-002586-64
    A.3Full title of the trial
    A randomized, pharmacodynamic study of cangrelor administration in STEMI patients loaded with ticagrelor
    Χορήγηση κανγκρελόρης μετά από φόρτιση με τικαγκρελόρη έναντι φόρτισης με τικαγκρελόρη μόνον σε ασθενείς με οξύ έμφραγμα του μυοκαρδίου με ανάσπαση του διαστήματος ST: Τυχαιοποιημένη, φαρμακοδυναμική μελέτη
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, pharmacodynamic study of cangrelor administration in STEMI patients loaded with ticagrelor
    Σε ασθενείς με οξύ έμφραγμα του μυοκαρδίου με ανάσπαση του διαστήματος ST που έχουν λάβει φόρτιση με τικαγκρελόρη, μετρούμε την αντιδραστικότητα των αιμοπεταλίων μετά από χορήγηση καγκρελόρης και τη συγκρίνουμε με την ομάδα ελέγχου (χωρίς κανγκρελόρη)
    A.4.1Sponsor's protocol code numberISS13616
    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 SponsorELKE University of Athens
    B.1.3.4CountryGreece
    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 supportELKE University of Athens
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationELKE University of Athens
    B.5.2Functional name of contact pointELKE University of Athens
    B.5.3 Address:
    B.5.3.1Street AddressCh. Lada 6
    B.5.3.2Town/ cityAthens
    B.5.3.4CountryGreece
    B.5.4Telephone number00302103889194
    B.5.5Fax number00302103889008
    B.5.6E-mailrc@elke.uoa.gr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Kengrexal
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCANGRELOR TETRASODIUM
    D.3.9.4EV Substance CodeSUB182388
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameTicagrelor
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients.
    Στην παρούσα μελέτη σε ασθενείς με STEMI που υποβάλλονται σε πρωτογενή αγγειοπλαστική, έχουμε ως στόχο να συγκρίνουμε την αναστολή των αιμοπεταλίων που επιτυγχάνεται από την χορήγηση της κανγκρελόρης (δόση εφόδου και στάγδην έγχυση) σε ασθενείς που έλαβαν φόρτιση με τικαγκρελόρη στην πρώτη ιατρική επαφή έναντι της χορήγησης τικαγρελόρης μόνο, χορηγούμενη επίσης στην πρώτη επαφή με ιατρό.
    E.1.1.1Medical condition in easily understood language
    STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor vs ticagrelor alone loaded patients.
    Ασθενείς με STEMI και αγγειοπλαστική συγκρίνουμε την αναστολή των αιμοπεταλίων από την χορήγηση της κανγκρελόρης σε ασθενείς που έλαβαν φόρτιση με τικαγκρελόρη έναντι της χορήγησης τικαγρελόρης μόνο
    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
    In the present study, in STEMI patients undergoing primary PCI we aim therefore to compare platelet inhibition achieved in patients loaded with ticagrelor followed by cangrelor (bolus plus infusion) vs ticagrelor alone loaded patients. We hypothesize a superior antiplatelet effect of a cangrelor strategy peri-interventionally and as early as within 15 min of cangrelor infusion.
    Ο σκοπός αυτής της µελέτης είναι η φαρµακοδυναµική σύγκριση της κανγκρελόρης bolus και συνεχούς ενδοφλέβιας έγχυσης σε ασθενείς που έλαβαν φόρτιση με τικαγκρελορη 180 mg έναντι της χορήγησης μόνο τικαγκρελορης 180 mg σε έναν πληθυσµό ασθενών με STEMI

    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For patients included in the study must meet the following criteria:
    1. Provide signed inform consent form for any procedure that involves the study
    2. Patients with STEMI (ST segment elevation in at least two leads,> 2mm the precordial or> 1mm in inferior leads and new or suspected new-onset LBBB) who are going to perform primary angioplasty
    3. Not receiving inhibitor of P2Y12 receptor
    Για συµπεριληφθούν οι ασθενείς στη µελετη οφείλουν να πληρούν τα εξής κριτήρια:
    1. Παροχή φόρµας συναίνεσης για οποιαδηποτε διαδικασία που αφορά τη µελέτη
    2. Ασθενείς με STEMI ( ανάσπαση του ST διαστήματος σε τουλάχιστον δύο απαγωγές, > 2mm στις προκάρδιες ή >1mm στις κατώτερες και νέο ή πιθανολογούμενο νέας εμφάνισης LBBB) και προσέρχονται για πρωτογενή αγγειοπλαστική
    3. Δεν ελάμβαναν αναστολέα του P2Y12 υποδοχέα
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they met any of you following exclusion criteria:

    1. Known hypersensitivity reaction to tikagkrelor or kangkrelor or to any of excipients.
    2. Haemorrhagic diathesis: active pathological bleeding, serious hemorrhagic disorder, history of stroke or intracranial hemorrhage, mass lesion of the CNS or intracranial vascular disorder. Also gastro-intestinal bleeding within the last 6 months or major surgery in the last 30 days
    3. Chronic anticoagulant therapy,
    4. Recent angioplasty or coronary bypass surgery <3 months, low platelet count <100 000 / L,
    5. Hematocrit <30%
    6. creatinine clearance <30mL / min,
    7. Severe hepatic dysfunction,
    8. Use of potent inhibitors (amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, conivaptan, clarithromycin, itraconazole, ketoconazole) or inducers of CYP3A (Carbamazepine, Dexamethasone, Glucocorticoids, Phenytoin Primidone, Progesterone, Phenobarbital, Sulfinpyrazone, Troglitazone)
    9. Increased risk of bradycardia (eg, sick sinus syndrome or third degree atrioventricular block or documented preceding syncope probably due to bradycardia unless treated with pacemaker implantation).
    10. Severe chronic obstructive pulmonary disease,
    11. Peri-procedural administration IIb / IIIa inhibitors.
    12. patient anable to attend the required follow-up or any other cause or condition makes the researcher to believe that the initiation of therapy under study would put the patient at increased risk
    Οι ασθενείς θα αποκλείονται από τη µελέτη εάν πληρούν κάποια από θα παρακάτω κριτήρια αποκλεισµού:
    1. Γνωστή αντίδραση υπερευαισθησία στην τικαγκρελόρη ή στην κανγκρελόρη ή σε κάποιο έκδοχό τους.
    2. Αιμορραγική διάθεση : ενεργός παθολογική αιµορραγία, σοβαρής αιµοραγική διαταραχή, ιστορικό αγγειακού εγκεφαλικού επεισοδίου ή ενδοκράνιας αιµορραγίας, χωροκατακτητική εργασία του ΚΝΣ ή ενδοκράνια αγγειακή διαταραχή. Επίσης αιµορραγία του γαστεντερικού κατά τη διάρκεια των τελευταίων 6µηνών ή µείζονα χειρουργική επέµβαση τις τελευταίες 30 ηµέρες
    3. Χρόνια θεραπεία με αντιπηκτικά,
    4. Πρόσφατη αγγειοπλαστική ή χειρουργείο αορτοστεφανιαίας παράκαμψης <3 μήνες, χαμηλός αριθμός αιμοπεταλίων <100 000/μL,
    5. Αιματοκρίτης <30%,
    6. Κάθαρση κρεατινίνης <30mL/min,
    7. Σοβαρή ηπατική δυσλειτουργία,
    8. Χρήση ισχυρών αναστολέων (amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, conivaptan, clarithromycin, itraconazole, ketoconazole) ή ευοδοτών του CYP3A (Carbamazepine, Dexamethasone , Glucocorticoids, Phenytoin Primidone , Progesterone ,Phenobarbital, Sulfinpyrazone, Troglitazone)
    9. Αυξημένος κίνδυνος για βραδυκαρδία, (π.χ σύνδροµο νοσούντος φλεβοκόµβου ή τρίτου βαθµού κολποκοιλιακού αποκλεισµού ή τεκµηριωµένο προηγηθέν συγκοπτικό επεισόδιο που πιθανόν οφείλεται σε βραδυκαρδία εκτός αν έχει αντιµετωπιστεί µε εµφύτευση βηµατοδότη).
    10. Σοβαρή χρόνια αποφρακτική πνευμονοπάθεια,
    11. Περιεπεμβατική χορήγηση αναστολέων IIb/IIIa.
    12. Αδυναµία του ασθενούς να ανταποκριθεί στα απαιτούµενα follow-up ή οποιοδήποτε άλλο λόγο ή συνθήκη κάνει τον ερευνητή να πιστεύει ότι η έναρξη της υπό µελέτη θεραπείας θα έθετε τον ασθενή σε αυξηµένο κίνδυνο
     
    E.5 End points
    E.5.1Primary end point(s)
    the primary end point of the study is the platelet reactivity between the two study groups in 15 minutes and will be measured in P2Y12 reaction units(PRU)
    Το πρωτεύον καταληκτικό σημείο της μελέτης θα είναι η αντιδραστικότητα των αιμοπεταλίων ανάμεσα στις δύο ομάδες στα 15 λεπτά µετρούµενη σε µονάδες αντιδραστικότητας P2Y12 reaction units (PRU)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day
    E.5.2Secondary end point(s)
    Secondary end point will be the Platelet reactivity between the two groups in 1, 2, and 4 hours, and the percentange of HPR in 15 minutes, 1, 2, 4 hours
    Δευτερογενή καταληκτικά σημεία θα είναι η αντιδραστικότητα των αιμοπεταλίων ανάμεσα στις δύο ομάδες την 1, 2 και 4 ώρα, όπως και το ποσοστό HPR στά 15 λεπτά, 1, 2 και 4 ώρα
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 day
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ticagrelor used as standard therapy
    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 concerned3
    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 No
    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 years1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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