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    Summary
    EudraCT Number:2019-001285-15
    Sponsor's Protocol Code Number:KOIIM-2019-1
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2019-001285-15
    A.3Full title of the trial
    Platelet inhibition with cangrelor in comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention
    Inhibicija trombocitov s kangrelorjem pri komatoznih bolnikih po izvenbolnišničnem srčnem zastoju in primarni perkutani koronarni intervenciji
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platelet inhibition with cangrelor in unconcious survivors of out-of-hospital cardiac arrest undergoing cardiac artery stent implantation
    Zaviranje delovanja trombocitov s kangrelorjem pri nezavestnih bolnikih po izvenbolnišničnem srčnem zastoju in razrešitvi zožitve na venčni arteriji z znotrajžilno opornico
    A.4.1Sponsor's protocol code numberKOIIM-2019-1
    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 SponsorUniversity Medical Centre Ljubljana
    B.1.3.4CountrySlovenia
    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 supportChiesi Slovenija
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Ljubljana
    B.5.2Functional name of contact pointMarko Noc
    B.5.3 Address:
    B.5.3.1Street AddressZaloska cesta 7
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number+38615222296
    B.5.6E-mailmarko.noc@mf.uni-lj.si
    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 kangrelor 50 mg (Kangrexal)
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 nameKangrexal
    D.3.2Product code 1045926
    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
    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
    Comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention
    Komatozni bolniki po izvenbolnišničnem srčnem zastoju in primarni perkutani koronarni intervenciji
    E.1.1.1Medical condition in easily understood language
    Unconscious survivors of out-of-hospital cardiac arrest undergoing cardiac artery stent implantation
    Nezavestni bolniki po izvenbolnišničnem srčnem zastoju in razrešitvi zožitve na venčni arteriji z znotrajžilno opornico
    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 main objective of the trial is to find out if 4-hour continuous infusion of parenteral P2Y12 inhibitor cangrelor at the start of primary percutaneous coronary intervention immediately and effectively suppresses platelet activity in comatose survivors of out-of-hospital cardiac arrest. Treatment with cangrelor is thereby supposed to bridge the gap of suboptimal platelet inhibition after administration of crushed and dissolved ticagrelor tablets via nasogastric or orogastric tube.
    Namen naše raziskave je preučiti ali štiriurna infuzija intravenskega inhibitorja P2Y12 kangrelorja ob začetku primarne perkutane koronarne intervencije takoj in ustrezno zavre trombocite pri komatonih bolnikih po izvenbolnišničnem srčnem zastoju. Aplikacija kangrelorja naj bi premostila obdobje do zadostnega antiagregacijskega učinka zdrobljenih tablet tikagrelorja, apliciranih po nazogastrični ali orogastrični sondi.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 18 to 70 years
    - comatose survivors of out-of-hospital cardiac arrest undergoing primary percutaneous coronary intervention
    - treatment with induced therapeutic hypothermia
    - no contraindication for dual antiplatelet therapy
    - starost 18 do 70 let
    - komatozni bolniki po izvenbolnišničnem srčnem zastoju z namenom opravljanja primarne perkutane koronarne intervencije
    - zdravljenje s terapevtsko hipotermijo
    - brez kontraindikacije za dvojno antiagregacijsko zdravljenje
    E.4Principal exclusion criteria
    - pregnancy
    - patients without return of spontaneous circulation or patients on ECMO
    - history of recent P2Y12 use (last 7 days)
    - history of recent vitamin K antagonist or NOAC use (last 14 days)
    - active bleeding
    - history of transient ischemic attack or cerebral vascular insult
    - strong bleeding tendency (Child C liver cirrhosis, stage IV-V chronic renal disease)
    - history of allergic reactions to acetylsalicylic acid, heparin or P2Y12 inhibitors
    - terminal disease or life expectancy less than 1 year
    - nosečnice
    - bolniki brez povrnitve spontanega krvnega obtoka, bolniki na izventelesnem krvnem obtoku
    - anamneza nedavnega jemanja inhibitorja P2Y12 (v zadnjh 7 dneh)
    - anamneza nedavnega jemanja antagonistov vitamina K ali novih antikoagulantnih zdravil (v zadnjih 14 dneh)
    - aktivna krvavitev
    - anamneza predhodne ishemične možganske kapi ali tranzitornega ishemičnega napada,
    - pomembna nagnjenost h krvavitvam (jetrna ciroza Child C, kronična ledvična odpoved 4.-5. stopnje)
    - anamneza alergične reakcije na acetilsalicilno kislino, heparin ali inhibitorje P2Y12
    - terminalna bolezen ali pričakovana življenjska doba manj kot 1 leto
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Platelet inhibition measured by VerifyNow and Multiplate 1, 3 and 5 hours after the start of cangrelor infusion
    Primary safety endpoint: Bleeding (BARC score), need for discontinuation of cangrelor infusion due to significant bleeding
    Primarni cilj učinkovitosti: Inhibicija trombocitov glede na VerifyNow in Multiplate metodo 1, 3 in 5 ur po začetku infuzije kangrelorja
    Primarni cilj varnosti: Krvavitve (BARC točkovnik), potreba po ukinitvi infuzije kangrelorja zaradi pomembne krvavitve
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the start of the primary percutaneous coronary intervention cangrelor infusion will be started and 1, 3 and 5 hours after initiating the infusion blood samples will be drawn to determine platelet inhibition with VerifyNow and Multiplate methods. Safety profile will be closelly followed until the infusion will be stopped and patients will be monitored in the intensive therapy unit.
    Ob začetku primarne perkutane koronarne intervencije bomo pričeli s kontinuirano infuzijo kangrelorja ter 1, 3 in 5 ure za tem odvzeli kri za določitev zavore trombocitov po metodah VerifyNow in Multiplate. Varnostni profil bomo spremljali ves čas do zaključka infuzije kangrelorja, saj bodo bolniki monitorizirani v sobi intenzivne terapije.
    E.5.2Secondary end point(s)
    Secondary endpoints: Final angiographic result as evaluated by independent blinded interventional cardiologist, probable/definite stent thrombosis during hospital stay, hospital survival, hospital survival with good neurological outcome (CPC 1-2)
    Sekundarni cilji: Končni angiografski rezultat ocenjen s strani neodvisnega interventnega kardiologa, verjetna/gotova stent tromboza med hospitalizacijo, preživetje v bolnišnici, preživetje v bolnišnici z dobrim nevrološkim izhodom (CPC 1-2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final angiographic result will be evaluated on the following working day after primary percutaneous coronary intervention. All other secondary endpoints will be evaluated for the time of hospital stay.
    Končni angiografski rezultat bo ocenjen naslednji delovni dan po primarni perkutani koronarni intervenciji. Ostali sekundarni cilji bodo spremljani za čas hospitalizacije.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Established care with ticagrelor crushed and dissolved tablets via nasogastric or orogastric tube
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    End of trial after 30 enrolled patients (15 test, 15 standard care), block randomization.
    Zaključek raziskave po 30 vključenih bolnikih (15 zdravilo, 15 standardna terapija), "block" randomizacija.
    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 months6
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-03-25. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Comatose patients following cardiac arrest, not able giving consent
    Komatozni bolniki po srčnem zastoju nezmožni podati soglasje
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Cardiac arrest patients (comatose)
    Bolniki po srčnem zastoju (komatozni)
    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 Decision2019-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-21
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