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    Summary
    EudraCT Number:2020-003320-16
    Sponsor's Protocol Code Number:CEL-03
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-09-02
    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 number2020-003320-16
    A.3Full title of the trial
    A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting
    Een fase 3 prospectief, geblindeerd, gerandomiseerd, placebo-gecontroleerd, internationaal multi-center onderzoek naar de veiligheid en werkzaamheid van een enkele pre-hospitale subcutane injectie van zalunfiban bij proefpersonen met ST-elevatie myocardinfarct
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effects of a platelet inhibitor (zalunfiban). This platelet inhibitor is given by a single subcutaneous injection.
    Targeted patients are patients with an acute myocardial infarction. The medication will be given in the ambulance. Subsequently a coronary angiography will be perormed and if needed the patient will be treated with primary coronary angioplasty
    Een onderzoek om de effecten van een bloedplaatjesremmer (zalunfiban) te beoordelen. Deze bloedplaatjesremmer wordt toegediend via een éénmalige onderhuidse injectie. De doelgroep is patiënten met een acuut myocardinfarct. Het medicament wordt geïnjecteerd in de ambulance. Vervolgens zal een coronaire angiografie worden uitgevoerd en zo nodig zal de patiënt aansluitend worden behandeld met een Dotter-behandeling.
    A.3.2Name or abbreviated title of the trial where available
    CELEBRATE
    CELEBRATE
    A.4.1Sponsor's protocol code numberCEL-03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04825743
    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 SponsorCeleCor Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCeleCor Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiagram BV
    B.5.2Functional name of contact pointS. Postma
    B.5.3 Address:
    B.5.3.1Street AddressDokter Stolteweg 96
    B.5.3.2Town/ cityZwolle
    B.5.3.3Post code8025 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003138426 2999
    B.5.6E-mails.postma@diagram-zwolle.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 No
    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 namezalunfiban
    D.3.2Product code 140962
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNzalunfiban
    D.3.9.2Current sponsor codeRUC-4
    D.3.9.3Other descriptive nameGLYCOPROTEIN IIB/IIIA
    D.3.9.4EV Substance CodeSUB194833
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is anticipated to be within 4 hours.
    Patiënten met een gedocumenteerde STEMI, die zich presenteren met aanhoudende klachten van pijn op de borst (> 10 min) en nieuwe ST-segment elevatie van ≥ 2 mm in 2 aangrenzende ECG-afleidingen, bij wie de totale duur van de klachten tot aan de diagnostische ECG minder dan 4 uur zal zijn.
    E.1.1.1Medical condition in easily understood language
    Patients with an Acute Myocardial Infarction presenting with specific abnormalities on their electrocardiogram. These patients are scheduled to undergo PCI (dotter treatment).
    Patiënten met een acuut myocardinfarct met specifieke afwijkingen op hun elektrocardiogram. Waarvan verwacht wordt dat zij met spoed een PCI (dotterbehandeling) zullen ondergaan.
    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 10028593
    E.1.2Term Myocardial disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028600
    E.1.2Term Myocardial ischaemia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10081099
    E.1.2Term Acute cardiac event
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10062084
    E.1.2Term Platelet aggregation
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10050661
    E.1.2Term Platelet aggregation inhibition
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy:
    - To assess the clinical outcome at 30-day follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in STEMI subjects in the pre-hospital setting.

    Safety:
    - To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and, for information only, according to the Bleeding Academic Research Consortium [BARC] Types 3C and 5 criteria after a single subcutaneous injection of zalunfiban versus placebo at 30-day follow-up.
    Effectiviteit:
    - Beoordelen van de klinische uitkomst op dag 30 na een éénmalige pre-hospitale subcutane injectie van zalunfiban versus placebo in patiënten met STEMI.

    Veiligheid:
    - Beoordelen van bloeding complicaties (volgens GUSTO en BARC Type 3C en 5 criteria) op dag 30 na een éénmalige subcutane injectie van zalunfiban versus placebo.
    E.2.2Secondary objectives of the trial
    To assess after a single s.c. injection of zalunfiban vs placebo:
    Efficacy:
    -Restoration of the culprit coronary artery blood flow of the Culprit before intended PCI (or post-CAG in case no PCI performed)
    -Resolution of ST-segment deviation post-PCI/CAG
    - Blinded bail-out use of IV αIIbβ3 receptor antagonists or IV P2Y12 antagonist at 24 hours post-PCI/angiography

    Safety:
    -Safety throughout study
    -Platelet count pre-PCI/CAG, post-PCI/CAG, 6hr post-PCI/CAG, 24hr post-PCI/CAG and at discharge/72hr post-PCI (whichever occurs first)
    - Bleeding events at 30 day FU:
    - According to ISTH Major
    - According to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria)
    -The injection site reactions of a single s.c. injection of zalunfiban versus placebo at baseline, 1hr post-PCI/CAG, hospital discharge/72hr post-PCI/CAG, and at 30-day FU
    Beoordelen na een eenmalige s.c. injectie zalunfiban vs placebo van:
    Effectiviteit:
    - Herstel van de 'culprit' coronaire bloedstroom ((corrected TIMI Frame Count)) vóór de beoogde PCI (of na CAG in geval geen PCI verricht)
    -Resolutie van de ST-segment deviatie post-PCI/CAG
    -Geblindeerd bail-out gebruik van IV αIIbβ3-antagonisten of IV P2Y12-antagonist 24u post-PCI/CAG

    Veiligheid:
    -Veiligheid gedurende de studie
    -Aantal bloedplaatjes pre-PCI/CAG, post-PCI/CAG, 6u post-PCI/CAG, 24u post-PCI/CAG en bij ontslag/72u post-PCI/CAG (welke het eerst plaatsvindt)
    -Bloeding complicaties op dag 30:
    - Volgens ISTH Major
    - Volgens GUSTO en BARC type 2, 3, en 5 criteria, ISTH Minor en/of Major, en TIMI Minor en Major criteria)
    -De reacties op de injectieplaats van een enkele s.c. injectie van zalunfiban versus placebo op baseline, 1u post-PCI/CAG, op moment v ontslag/72u post-PCI/CAG, en op dag 30
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study pharmacodynamic effects version 1.1 07Aug2023:
    Title:
    Investigation of the Pharmacodynamic effects of pre-hospital administered zalunfiban in subjects with ST-elevation myocardial infarction.
    Primary objective:
    To compare the results of the VerifyNow™ assay, i.e., platelet reactivity and degree of platelet inhibition, in subjects with STEMI receiving zalunfiban to placebo.
    Secondary objectives:
    - To compare clot strength and other clot kinetics
    - To correlate the platelet reactivity with angiographic markers of reperfusion. These indices include pre-procedural TIMI flow grade, TIMI myocardial perfusion grade and TIMI thrombus grade.
    - To correlate platelet reactivity ECG markers of reperfusion including ST-segment resolution pre-angiography (presentation/ED ECG – diagnostic ECG), both qualitative and quantitative.
    - To correlate the primary outcome of this sub-study with clinical endpoints from the main study.
    Sub-onderzoek farmacodynamische effecten versie 1.1 07Aug2023:
    Titel:
    Onderzoek naar de farmacodynamische effecten van pre-hospitaal toegediende zalunfiban bij personen met ST-elevatie myocardinfarct.
    Primaire doelstelling:
    Vergelijken van de resultaten van de VerifyNow™ assay, d.w.z. de bloedplaatjes reactiviteit en de mate van bloedplaatjesremming, bij proefpersonen die behandeld zijn met zalunfiban met proefpersonen die behandeld zijn met placebo.
    Secundaire doelstellingen:
    - Vergelijken van de stollingssterkte en andere stollingskinetiek
    - Correleren van de bloedplaatjesreactiviteit met angiografische markers van reperfusie. Deze indicatoren zijn pre-procedurele TIMI flow grade, TIMI myocard perfusie grade en TIMI trombus grade.
    - Correleren van de bloedplaatjesreactiviteit met ECG-markers van reperfusie, waaronder ST-segmentresolutie vóór de angiografie (presentatie ECG - diagnostisch ECG), zowel kwalitatief als kwantitatief.
    - Correleren van de primaire uitkomst van deze sub studie met de klinische eindpunten van het hoofdonderzoek
    E.3Principal inclusion criteria
    - Planned transport to participating clinical site
    - Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
    - Weight (by history) between 52 and 130 kg (115 and 287 lb).
    - Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum.
    - Enrollment by EFIC process, verbal witnessed/short written
    informed consent, or written informed consent will be
    obtained in the acute phase by (para)medics [Romania and
    other select sites with the sponsor’s approval: clinical site
    personnel, if greater than 30 minutes of delay is anticipated for
    door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the
    subject’s clinical condition allows it.
    - Gepland transport naar deelnemend centrum
    - Mannen van ≥18 jaar of postmenopauzale of chirurgisch steriele vrouwen van ≥50 jaar of ≥55 jaar (alleen voor Tsjechië).
    - Gewicht (in voorgeschiedenis) tussen 52 en 130 kg.
    - Patiënten met een gedocumenteerde STEMI, die zich presenteren met aanhoudende ischemische pijn op de borst (>10 minuten) en nieuwe ST-segment elevatie van ≥2 mm in twee aangrenzende ECG-afleidingen, waarbij de totale duur van de symptomen maximaal 4 uur tot aan de diagnostische ECG zal zijn.
    - Inclusie via EFIC-proces, mondeling of beknopt schriftelijke geïnformeerde toestemming, of schriftelijke geïnformeerde toestemming zal worden verkregen in de acute fase door hoog opgeleide (para)medici [Roemenië en andere geselecteerde centra met toestemming van de sponsor: door personeel van klinische locatie, indien meer dan 30 minuten vertraging wordt verwacht voor door-to-balloon tijd]. De proefpersoon is bereid en in staat om geïnformeerde toestemming te geven. Schriftelijk geïnformeerde toestemming zal worden verkregen zodra de klinische toestand van de proefpersoon dit toelaat.
    E.4Principal exclusion criteria
    - Cardiopulmonary Resuscitation for current Out of Hospital Cardiac Arrest.
    - Cardiogenic shock presenting with systolic blood pressure <90 mmHg confirmed on repeat testing and heart rate >100 beats per minute.
    - Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines.
    - Currently treated with renal dialysis.
    - Current treatment with oral anticoagulation (Vitamin K antagonists* or direct oral anticoagulants**) and thrombolytic agents***. For example.
    * acenocoumarol or phenprocoumon, fluindione, and Coumadin (warfarin)
    ** dabigatran, apixaban, edoxaban, rivaroxaban, and betrixaban
    *** tenecteplase, alteplase, reteplase, streptokinase, and urokinase
    - Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
    - Known history of ischemic or hemorrhagic stroke.
    - Known severe anemia (regular blood transfusion needed).
    - Previously enrolled in this study.
    - Participation in another clinical study with an investigational product or device within the past month.
    - Life expectancy less than one year.
    -Cardiopulmonaire Resuscitatie (CPR) voor de huidige Out of Hospital Cardiac Arrest (OHCA).
    - Cardiogene shock met systolische bloeddruk <90 mmHg bevestigd bij herhaling en hartslag >100 slagen per minuut.
    -Huidige coronavirusziekte 2019 (COVID-19) infectie (volgens de criteria van de lokale richtlijnen).
    -Momenteel behandeld met nierdialyse.
    -Huidige behandeling met orale anticoagulantia (Vitamine K antagonisten* of direct werkende orale anticoagulantia**) en trombolytica. Bijvoorbeeld:
    * acenocoumarol of fenprocoumon, fluindione en Coumadin (warfarin)
    ** dabigatran, apixaban, edoxaban, rivaroxaban, en betrixaban
    *** tenecteplase, alteplase, reteplase, streptokinase, en urokinase
    -Grote chirurgische ingreep, of trauma of bloeding dat heeft geleid tot ziekenhuisopname in de afgelopen maand.
    -Ischemische of hemorragische beroerte in voorgeschiedenis.
    -Ernstige bloedarmoede in voorgeschiedenie (regelmatig bloedtransfusie nodig).
    - Eerdere deelname aan dit onderzoek.
    -Deelname aan een ander klinisch onderzoek met een onderzoeksproduct of -hulpmiddel in de afgelopen maand.
    - Levensverwachting minder dan een jaar.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    To assess after a single subcutaneous injection of zalunfiban versus
    placebo:
    Clinical outcome as assessed by a 7-point scale. The 7 outcomes,
    ranking from worst to best, are:
    a. Death (all cause) at 30-day follow-up
    b. Stroke at 30-day follow-up
    c. Recurrent MI (Types 1 to 4 MI) at 30-day follow-up
    d. Acute stent thrombosis at 24 hours post-PCI/angiography
    e. New onset HF or re-hospitalization for HF at 30-day follow-up
    f. MI with hs-cTnT levels ≥10 x ULN at 24 hours post-PCI/angiography
    g. None of the above

    Safety:
    To assess after a single subcutaneous injection of zalunfiban versus
    placebo:
    - Subject incidence of bleeding events (according to GUSTO
    severe or life-threatening criterion for safety assessment and, for
    information only, according to the BARC Types 3C and 5 criteria)
    at 30-day follow-up
    Effectiviteit:
    Beoordelen na een eenmalige subcutane injectie van zalunfiban versus placebo:
    Klinische uitkomst beoordeeld door een 7-punts schaal. De 7 uitkomsten, gerangschikt van slecht naar best, zijn:
    a. Overlijden (alle oorzaken) na 30 dagen follow-up
    b. Beroerte na 30 dagen follow-up
    c. Recidiverend MI (type 1 tot 4 MI) bij 30 dagen follow-up
    d. Acute stenttrombose binnen 24 uur na PCI/angiografie
    e. Nieuw hartfalen of hospitalisatie voor hartfalen na 30 dagen follow-up
    f. MI met hs-cTnT niveaus ≥10x ULN op 24 uur na PCI/angiografie
    g. Geen van bovenstaande

    Veiligheid:
    Beoordelen na een eenmalige subcutane injectie van zalunfiban versus placebo:
    - Incidentie van bloeding complicaties (volgens GUSTO criteria en, uitsluitend ter informatie, volgens de BARC Type 3C en 5 criteria) op dag 30
    E.5.1.1Timepoint(s) of evaluation of this end point
    see primary end points (E.5.1)
    zie primaire eindpunten (E.5.1)
    E.5.2Secondary end point(s)
    Efficacy:
    To assess after a single subcutaneous injection of zalunfiban versus
    placebo:
    - As assessed by an independent Core Laboratory: Corrected TIMI
    Frame Count of the Infarct-Related Artery (Culprit) before
    PCI/angiography
    - As assessed by an independent Core Laboratory: ST-segment
    deviation resolution 1-hour post-PCI/angiography
    - Blinded bail-out use of IV αIIbβ3 receptor antagonists or IV P2Y12 antagonists at 24 hours post-PCI/angiography

    Safety
    To assess after a single subcutaneous injection of zalunfiban versus
    placebo:
    - Recording of AEs and SAEs: AEs up to 30-day follow-up; SAEs up
    to resolution/stabilization, the SAEs mortality and hospitalization
    for HF and atrial fibrillation up to 12-months follow-up
    - Platelet count before PCI/angiography, at the end of the
    PCI/angiography, 6 and 24 hours post-PCI/angiography, and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)
    - Subject incidence of bleeding events (according to ISTH Major
    and, for information only, TIMI Major) at 30 days follow-up
    - Subject incidence of bleeding events according to GUSTO mild
    and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria at 30-day follow-up
    - Subject incidence of injection site reactions at baseline, 1-hour
    post-PCI/angiography, hospital discharge/72-hours post- PCI/angiography, and at 30-day follow-up
    Effectiviteit:
    Beoordelen na een eenmalige subcutane injectie van zalunfiban versus placebo van:
    - Zoals beoordeeld door een onafhankelijk lab: Corrected TIMI Frame Count van de ‘Culprit’ vóór PCI/angiografie
    - Zoals beoordeeld door een onafhankelijk lab: ST-segment deviatie resolutie 1 uur na PCI/angiografie
    - Geblindeerd bail-out gebruik van IV αIIbβ3-antagonisten of IV P2Y12-antagonisten of acute stenttrombose op 24 uur na de PCI/angiografie

    Veiligheid
    Beoordelen na een eenmalige subcutane injectie van zalunfiban versus placebo van:
    - (Eernstige) bijwerkingen:
    - Bijwerkingen tot 30 dagen follow-up;
    - Ernstige bijwerkingen tot resolutie/stabilisatie, de mortaliteit en ziekenhuisopname voor hartfalen en atriumfibrilleren tot 12-maanden follow-up
    - Aantal bloedplaatjes, aan het eind van de PCI/angiografie, 6 en 24 uur na de PCI/angiografie, en op moment van ontslag uit het ziekenhuis/72 uur na de PCI/angiografie (wat zich het eerst voordoet)
    - Incidentie van bloeding complicaties (volgens de ISTH Major en, uitsluitend ter informatie, TIMI Major) op dag 30
    - Incidentie van bloeding complicaties volgens GUSTO Minor en Major criteria, BARC Type 2, 3, en 5 criteria, ISTH Minor en major, en TIMI Minor vóór PCI/angiografie en Major criteria op dag 30
    - Incidentie van reacties op de injectieplaats vóór PCI/angiografie, 1 uur na PCI/angiografie, op moment van ontslag uit het ziekenhuis/72 uur na de PCI/angiografie (wat zich het eerst voordoet), en op dag 30
    E.5.2.1Timepoint(s) of evaluation of this end point
    see secondary end points (E.5.2)
    zie secundaire eindpunten (E.5.2)
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    United States
    Czechia
    France
    Hungary
    Netherlands
    Romania
    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
    A subject is considered to have completed the study if he/she has completed the 30-day FU visit. After Day 30 FU visit, subjects will continue to long-term assessment at Month 12.
    The end of the study is met when all subjects have completed all assessments, all subject data have been cleaned, and the study sites have been closed.
    A possible reason for early study termination includes that the SRC makes a decision for the early termination of the study per recommendation.
    Een proefpersoon heeft de studie voltooid als hij/zij het dag 30 FU-bezoek heeft voltooid. Na het dag 30 FU-bezoek gaan de proefpersonen door naar de langetermijnbeoordeling op maand 12.
    Het einde v d studie is bereikt wanneer alle proefpersonen alle beoordelingen hebben voltooid, alle proefpersonengegevens zijn opgeschoond en de centra zijn gesloten. Een reden voor vroegtijdige beëindiging v d studie is dat op voorspraak v d SRC een besluit genomen wordt om de studie voortijdig te beëindigen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1499
    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 No
    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 state1619
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2399
    F.4.2.2In the whole clinical trial 2499
    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
    Geen
    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 Decision2020-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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