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    Summary
    EudraCT Number:2015-001923-22
    Sponsor's Protocol Code Number:ADENOSINE-1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-19
    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 number2015-001923-22
    A.3Full title of the trial
    The effect of adenosine on myocardial protection in intermittent warm blood cardioplegia: a randomized placebo-controlled trial
    Het effect van adenosine op myocardiale bescherming in intermitterende warme bloedcardioplegie: een gerandomiseerd placebo-gecontroleerd onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adenosine as an adjunct to standaard blood cardioplegia
    adenosine als een toevoeging aan standaard bloedcardioplegie
    A.4.1Sponsor's protocol code numberADENOSINE-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 SponsorAmphia Ziekenhuis
    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 supportAmphia Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmphia Ziekenhuis
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMolengracht 21
    B.5.3.2Town/ cityBreda
    B.5.3.3Post code4818CK
    B.5.3.4CountryNetherlands
    B.5.6E-mailjengelhart@amphia.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 Adenocor
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    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 Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdenosine
    D.3.9.3Other descriptive nameADENOSINE
    D.3.9.4EV Substance CodeSUB00297MIG
    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 placeboConcentrate and solvent for solution for injection/infusion
    D.8.4Route of administration of the placeboIntracardiac use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative cardiac damage in patients scheduled for minimal invasive, port-access operations
    Post-operatieve cardiale schade in patienten gepland voor minimaal invasieve, port-access operaties
    E.1.1.1Medical condition in easily understood language
    Post-operative cardiac damage
    Post-operatieve cardiale schade
    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 this study is to determine whether adenosine-enriched intermittent 20:1 diluted warm blood cardioplegic solution compared to standard intermittent 20:1 diluted warm blood cardioplegic solution improves 6-hours postoperative myocardial protection, determined as cardaic troponine T (cTnT ) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
    Het doel van deze studie is het vaststellen of een adenosine-verrijkte intermitterende 20:1 verdunde warme bloedcardioplegie oplossing in vergelijking met de standaard intermitterende 20:1 verdunde warme bloedcardioplegie oplossing de 6-uurs post-operatieve myocardiale bescherming verbetert, bepaald als cardiaal troponine T (cTnT), in patienten die een minimaal invasieve, port-access operatie (mitralis klep chirurgie) moeten ondergaan.
    E.2.2Secondary objectives of the trial
    As secondary objectives, we would like to evaluate differences in the 18-hours postoperative area-under-the-curve (AUC) release of cTnT, pre- and postoperative enzymatic release of creatinine kinase-MB (CK-MB), mean arterial pressure, heart rate, cardiac index, systemic vascular resistance index, and inotropic score, incidence of new onset atrial fibrillation, and differences in pre- and postoperative left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) determined by 3-dimensional transesophageal echocardiography (TEE).
    Als secundaire doelen willen we het verschil in 18-uurs post-operatieve area-under-the-curve (AUC) afgifte van cTnT evalueren, verschil in pre- en post-operatieve enzymatische afgifte van creatine kinase-MB (CK-MB), gemiddelde arteriele druk, hartfrequentie, cardiac index, systemische vasculaire weerstand index, en inotropie score, incidentie van new onset atriumfibrilleren, en verschil in pre- en post-operatieve linker ejectiefractie (LVEF) en wall motion score index (WMSI) bepaald door driedimensionaal transoesofageale echocardiografie (TEE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Gender; male/ female
    • Age: ≥ 18 year
    •Elective cardiac surgical patients: - minimally invasive, port access surgery (mitral valve surgery)
    • Geslacht; man/vrouw
    • Leeftijd: ≥ 18 jaar
    •Electieve cardiochirurgische patienten: - minimaal invasieve, port-access chirurgie (mitralis klep chirurgie)
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participation in this study:
    • All non-minimally invasive surgery
    • Theophylline or dipyridamole use
    • Caffeine use up to 12 hours prior to surgery
    Alle patienten met onderstaande criteria worden geëxludeerd van deelname in deze studie:
    • Alle non-minimalal invasieve, port access chirurgie
    • Theophylline of dipyridamol gebruik
    • Caffeine gebruik tot 12 uur voor chirurgie
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is post-operative 6-hour cardiac troponin T release.
    Het primaire eindpunt is post-operatieve 6-uurs cardiaal troponine T afgifte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-operative 6 hours after surgical procedure.
    Post-operatief 6 uur na chirurgische procedure.
    E.5.2Secondary end point(s)
    Secondary cardiac end points are:
    • 18-hour postoperative AUC release of cardiac troponine T
    Routine blood samples pre-operatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2), and 18 hours after arrival at ICU (T3).
    • Incidence of myocardial injury on 12-lead ECG
    - New-onset Left bundle branch block (LBBB)
    - New-onset Q wave
    • Vasoactive-inotropic score
    • Vasoconstrictor usage
    • Incidence of new onset AF
    • Routine blood samples preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2)
     CK-MB
     Creatinine
    • Haemodynamic monitoring
     Mean arterial pressure
     Heart rate
     Cardiac index
     Systemic vascular resistance index
    • 3-D TEE postoperative LVEF and Wall Motion Score Index (WMSI) after skin closure
    Secoudaire cardiale eindpunten zijn:
    • 18-uurs post-operatieve AUC afgifte van cardiac troponine T
    Routine bloedmonsters pre-operatief van perifeer bloed (T0); post-operatief, van perifeer bloed bij aankomst ICU (T1) en 6 uur na aankomst ICU (T2), en 18 uur na aankomst ICU (T3).
    • Incidentie van myocardiale schade via 12-lead ECG
    - New-onset linker bundeltak blok (LBBB)
    - New-onset Q wave
    • Vasoactieve-inotropie score
    • Vasoconstrictor gebruik
    • Incidentie van new onset AF
    • RRoutine bloedmonsters pre-operatief van perifeer bloed (T0); post-operatief, van perifeer bloed bij aankomst ICU (T1) en 6 uur na aankomst ICU (T2):
     CK-MB
     Creatinine
    • Haemodynamische monitoring:
     Mean arterial pressure
     hartfrequentie
     Cardiac index
     Systemic vascular resistance index
    • 3-D TEE postoperatieve LVEF en Wall Motion Score Index (WMSI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    preoperative one day
    post-operative at arrival at ICU, one day, discharge ICU
    pre-operatief één dag
    post-operatief bij aankomst ICU, één dag, ontslag ICU
    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 No
    E.6.5Efficacy No
    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 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 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.8.5The 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
    All AEs will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist.
    SAEs need to be reported till end of study within the Netherlands, as defined in the protocol.
    Alle bijwerkingen worden gevolgd tot zij zijn afgenomen, of totdat een stabiele situatie is bereikt. Afhankelijk van het evenement, de followup kunnen aanvullende tests of medische procedures, zoals aangegeven, en / of verwijzing naar de huisarts of medisch specialist.
    SAE's moeten worden gemeld tot einde van de studie binnen Nederland, zoals gedefinieerd in het protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 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 state100
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-16
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