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    Summary
    EudraCT Number:2013-001636-22
    Sponsor's Protocol Code Number:TROPICALACS
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-07
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-001636-22
    A.3Full title of the trial
    A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrome patients undergoing coronary stenting
    Prospektív, randomizált, párhuzamos, nyílt, multicentrikus non-inferiority tanulmány a rövid-idejű, trombocita funkció mérés alapján irányított és a standard, 12 hónapos prasugrel kezelés összevetéséről akut koronária szindróma miatt koronária-intervención átesett betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of a 12 month vs. a short-term therapy with prasugrel in patients with acute heart attack undergoing coronary stenting
    A 12 hónapos és a vérlemezke mérés által irányított rövid-távú prasugrel kezelés összevetése szívinfarktuson átesett betegek körében
    A.3.2Name or abbreviated title of the trial where available
    TROPICAL-ACS
    TROPICAL-ACS
    A.4.1Sponsor's protocol code numberTROPICALACS
    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 SponsorHospital of the University of Munich, Grosshadern
    B.1.3.4CountryGermany
    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 supportRoche Diagnostics International AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of the University of Munich, Grosshadern
    B.5.2Functional name of contact pointI. Med. Klinik und Poliklinik
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989440072371
    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.2.1.2Country which granted the Marketing AuthorisationHungary
    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 Film-coated 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 INNClopidogrel
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Troponin positive acute coronary syndrome after successful percutaneous coronary intervention with an indication for a standard treatment of 12 month with prasugrel
    Troponin pozitív akut koronária szindróma miatt sikeres perkután koronária intervención átesett betegek, akiknél 12 hónapos prasugrel kezelés javallt
    E.1.1.1Medical condition in easily understood language
    Troponin positive acute heart attack after successful cardiac catheter treatment with an indication for a standard treatment of 12 month with prasugrel
    Szívinfarktus miatt koszorúér tágításon átesett betegek, akiknél egy évig vérlemezke gátló kezelés javasolt
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    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
    A Platelet function testing guided approach with a short-term (1 week) post hospital discharge prasugrel maintenance dose treatment and a switch-over to clopidogrel treatment in adequate responders to the drug is non-inferior to the currently recommended long-term (12 month) treatment with prasugrel in ACS patients undergoing PCI.
    Akut koronária szindróma miatt koronária-intervención átesett betegeknél a trombocita-funckió mérés alapján irányított, rövid (egy hetes) prasugrel kezelés és hatékony clopidogrel terápia esetén clopidogrelre történő átállás nem rosszabb (non-inferior) a standard 12 hónapos prasugrel kezeléshez képest.
    E.2.2Secondary objectives of the trial
    - Bleeding events with a grade >= 2 defined according to BARC criteria
    - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria
    - Incidence of death from any cause
    - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients
    - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TROPICAL-ACS - PLATELET FUNCTION SUBSTUDY

    Related study site: Heart Center Balatonfüred

    Aim: Among participants enrolled into the TROPICAL-ACS clinical trial, we aim to perform a platelet function substudy (TROPICAL-ACS PFT substudy) to explore the pharmacodynamic effect of prasugrel and clopidogrel at various time points. Assessment of the achieved level of platelet reactivity in the two randomized arms of the TROPCAL-ACS trial is of great importance to better understand the mechanisms of action of the study drugs, development of adverse events and to corroborate clinical findings.

    Methods: In one of the participating Hungarian interventional cardiology centers of the TROPICAL-ACS trial (Heart Center Balatonfüred, Balatonfüred, Hungary), we aim to serially measure the level of platelet reactivity with standardized platelet function assays, such as the Multiplate and the VerifyNow devices at various time points after the index acute PCI.
    Since most patients with ACS who reach the cathlab are pretreated with clopidogrel in Hungary, the following time points for sampling are planned: time point 1 (T1): 6-48 hours after clopidogrel 600 mg loading dose; time point 2 (T2): at discharge, on prasugrel therapy; time point 3 (T3): at day 14, when all patients are returned to a protocol-dirven testing; and time point 4 (T4): 30-60 days after PCI, on chronic prasugrel or clopidogrel treatment (See Figure 1).
    The selected platelet function assays in the substudy include the VerifyNow P2Y12 assay and the Multiplate analyzer with ADP and ASPI test.

    Endpoints: The primary goal of the platelet function substudy is to compare P2Y12-related platelet reactivity in the MONITORING and the CONTROL treatment groups at all respective time points. The parameters of interest are the follows: (1) ADP-dependent platelet reactivity with Multiplate ADP-test and VerifyNow P2Y12 kit; (2) Arachidonic acid-dependent platelet reactivity with Multiplate ASPI-test, (3) proportion of patients with low (LPR), optimal (OPR) and high platelet reactivity (HPR) according to Multiplate ADP-test and VerifyNow P2Y12 kit. LPR-OPR-HPR categories are defined according to a recent consensus paper in JACC (PMID: 24076493, Table 1.).

    Statistical analysis and sample size calculation: The final strategy of P2Y12- inhibition in the MONITORING arm will be selected on the basis of platelet testing at day 14. Therefore, the primary endpoint aims to compare platelet reactivity with Multiplate at T4, when the antiplatelet regimen is fixed in both groups. By hypothesizing a mean AUC value of 25±15 U in the CONTROL arm and 35±15 U in the MONITORING arm, 96 patients is required to be able to demonstrate a significant difference at a two-sided alpha level of 0.05 with 90% power. Therefore, we aim to recruit 100 patients (50 patients in each group) in the platelet function substudy.
    TROPICAL-ACS - TROMBOCITA FUNKCIÓS ALVIZSGÁLAT

    Vizsgálati bevonásban részt vevő centrum: Állami Szívkórház Balatonfüred

    Célkitűzés: A TROPICAL-ACS klinikai vizsgálatba bevont betegek körében tervezzük egy trombocita funkciós alvizsgálat létrehozását (TROPICAL-ACS PLT substudy), hogy megvizsgáljuk a tanulmányban adott clopidogrel és prasugrel gyógyszerek farmakodinámiás hatását a bevonástól számított különböző időpontokban. A trombocita funkciós vizsgálatok a randomizált vizsgálat két vizsgálati csoportjában igen nagy jelentőségűek a két csoportban alkamazott P2Y12-receptor gátló kezelés hatékonyságának elemzéséhez, az esetlegesen bekövetkező klinikai események megértéséhez és hogy laboratóriumi szinten is alátámasszuk a klinikai végpontokban esetlegesen észlelt eltéréseket.
    Módszerek: A TROPICAL-ACS vizsgálat egyik magyar vizsgálati centrumában (Állami Szívkórház, Balatonfüred) a TROPICAL-ACS vizsgálatba bevont betegek körében tervezzük az alvizsgálat megvalósítását, mely során akut PCI utáni különböző időpontokban meghatározzuk a vizsgálati gyógyszerek vérlemezke- gátló hatását. Mivel a magyar vizsgálati centrumokban bevont beteg a PCI előtt túlnyomó többségben clopidogrel előkezelést kapnak, a következő trombocita funkciós mérési időpontokat tervezzük: 1. időpont (T1): 6-48 órával a 600 mg-os clopidogrel telítőadag után; 2. időpont (T2): hazabocsátáskor, már stabil prasugrel kezelés mellett; 3. időpont (T3): a 14. napon a PCI után, amikor is a fő vizsgálatban is trombocita funkciós vizsgálat van előírva; és 1-2 hónappal a PCI után (T4): a véglegesen kiválasztott clopidogrel vagy prasugrel kezelés mellett. (1. ábra)
    Az alvizsgálatban használt trombocita-funkciós eszközök közé tartozik a VerifyNow P2Y12 módszer és a Multipalte eszköz ADP és ASPI teszttel.
    Végpontok: A vizsgálat célja, hogy összehasonlítsa az elért P2Y12-receptor gátló hatást a MONITOROZOTT és a KONTROLL csoport között. A vizsgált végpontok a következők: (1) ADP-függő trombocita aggregáció Multiplate és VerifyNow módszerrel; (2) Arachidon-sav idukált trmbocita aggregáció mérése Multiplate módszerrel; (3) a Multiplate és a Verifynow módszerek által alacsony (LPR),

    optimális (OPR) vagy magas (HPR) trombocita-reaktivitással biró egyének elkülönítése a vizsgált csoportokban. Az LPR, OPR és HPR kategóriák meghatázotása egy nemrégiben publikált konszenzus dokumentum ajánlását veszi alapul (PMID: 24076493, Table 2).
    Statisztikai elemzés és minta elemszám kalkuláció:
    A végleges P2Y12-receptor gátló gyógyszer a TROPICAL-ACS vizsgálat MONITOROZOTT ágában a PCI utáni 14. napon (T3) fog eldőlni, a trombocita funkciós eredmény alapján. Emiatt a trombocita funkciós alvizsgálat elsődleges végpontja a T4 időpontban mért trombocita reaktivitás összevetése lesz a két vizsgálati csoportban, Multiplate módszerrel mérve. A prasugrel kezelés mellett a KONTROLL csoportban 25±15 U-os trombocita reaktivitási értéket, míg a MONITOROZOTT csoportban 35±15 U-os aggregációs értéket feltételezve 96 beteg szükséges ahhoz, hogy 90%-os statisztikai erővel ezt a különbséget egy két oldalú t-próbával 0,05-ös szignifikancia szint mellett igazolni lehessen. Emiatt a trombocita funkciós alvizsgálatba 100 beteg (csoportonként 50 fő) bevonását tervezzük.
    E.3Principal inclusion criteria
    - Patients with troponin positive ACS
    - Successful PCI (defined as a post PCI diameter stenosis <20% and TIMI flow >=2)
    - A planned treatment of prasugrel for 12 month after the procedure
    - Written informed consent
    - troponin-pozitív ACS-ben szenvedő betegek
    - akiknél sikeres koronária-intervenció történik (PCI-t követő <20% átmérő-szűkület és TIMI áramlás ≥ 2)
    - prasugrel terápia javasolható a műtét után 12 hónapig
    - írásos beteghozzájárulás
    E.4Principal exclusion criteria
    - Age < 18 years and > 80 years
    - Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
    - Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke
    - Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to the beginning of this clinical trial. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamines) for ≥7 days.
    - Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
    - Indication for major surgery (per decision of the treating physician) for the planned duration of the study
    - Simultaneous participation in another clinical trial that involves the administration of an investigational medicinal drug within 30 days prior to the beginning of this clinical trial.
    - Known or persistent abuse of medication, drugs or alcohol
    - Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator`s opinion
    - Evidence of significant active neuropsychiatric disease, in the investigator´s opinion
    • 18 évesnél fiatalabb vagy 80 évesnél idősebb beteg

    • a clopidogrelre vonatkozóan ellenjavallattal bíró betegek: a vizsgálati szer hatóanyagával vagy valamelyik összetevőjével szembeni intolerancia esetén, vagy aktív vérzéses esemény (fekélyvérzés, agyvérzés) fennállása esetén

    • a prasugrelre vonatkozóan ellenjavallattal bíró betegek: a vizsgálati szer hatóanyagával vagy valamelyik összetevőjével szembeni intolerancia esetén, aktív vérzéses esemény (fekélyvérzés, agyvérzés), valamint a kórelőzményben szereplő TIA vagy stroke fennállása esetén.


    • olyan egyének, akiknél két héttel a vizsgálat beleegyezés előtt szövődményes vagy tartós kardiogén sokk alakult ki. A szövődményes vagy tartós kardiogén sokk tekintendő minden olyan kardiogén sokk, ami 7 vagy több napig tartó gépi lélegeztetést és mechanikus keringéstámogatást igényel.


    • olyan betegek, akik tartós orális véralvadásgátló kezelést igényelnek (K-vitamin antagonistákkal vagy új orális véralvadásgátlókkal, mint pl. a rivaroxaban, dabigatran vagy apixaban)

    • nagy műtét javallata (a kezelőorvos megítélése szerint) a tanulmány tervezett időtartama alatt

    • egy másik klinikai tanulmányban való egyidejű részvétel vagy részvétel egy olyan klinikai tanulmányban, amelynek során a tanulmány kezdete előtt 30 napon belül vizsgálati gyógyszert kapott a beteg

    • ismert vagy hosszabb ideje tartó alkohol-, gyógyszer- vagy drogfüggőség

    • terhes nők vagy olyan nők, akik terhességet terveznek; szoptató nők; olyan nők, akik 90 napon belül szültek; fogamzóképes korú nők, akik a tanulmány időtartama alatt semmilyen hatékony fogamzásgátlást (orális, befecskendezhető vagy beültethető fogamzásgátlót vagy IUD-t) nem alkalmaznak vagy nem akarnak alkalmazni, kivéve a műtétileg sterilizált nőket vagy azokat, akiknek a méhét eltávolították, vagy ha vannak más kritériumok, amelyeket a vizsgálatot végző orvos adott esetben elég hatékonynak tart

    • a vizsgálatot végző orvos által komoly, aktív neuropszichiátriai betegségként értékelt betegség
    E.5 End points
    E.5.1Primary end point(s)
    Combined ischemic and bleeding endpoint, which is a composite endpoint consisting of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade >= 2 defined according to BARC (Bleeding Academic Research Consortium) criteria
    Ischaemiás és vérzési eseményekből álló kombinált végpont: szív- és érrendszeri halálozás, miokardiális infarktus, stroke vagy BARC (bleeding academic research consortium) kritériumok szerinti ≥ 2. fokozatú vérzések
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 30 days, 6 month and 12 month.
    30 nappal, 6 és 12 hónappal a PCI után.
    E.5.2Secondary end point(s)
    - Bleeding events with a grade >= 2 defined according to BARC criteria
    - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria
    - Incidence of death from any cause
    - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients
    - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis
    -- Incidence of cardiovascular death at 12 month
    -- Incidence of MI at 12 month
    -- Incidence of nonfatal stroke at 12 month
    • a BARC (bleeding academic research consortium) kritériumok szerinti ≥ 2. fokozatú vérzések
    • stent-trombosis (biztos vagy valószínű) az ARC (academic research consortium) kritériumok szerint
    • bármilyen okú halál
    • költséghatékonysági elemzés a trombocita-funkció mérés alapján irányított kezelés gazdaságosságáról
    • az elsődleges végpont alkotói önállóan
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 30 days, 6 month and 12 month.
    30 nappal, 6 és 12 hónappal a PCI után.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Since this is a multi-center , multi-national trial with a high amount of clinical data the end of study is defined as data base lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1100
    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 state1500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2600
    F.4.2.2In the whole clinical trial 2600
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-15
    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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