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    Summary
    EudraCT Number:2015-001006-34
    Sponsor's Protocol Code Number:2015C104
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-26
    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 number2015-001006-34
    A.3Full title of the trial
    Groningen Intervention study for the Preservation of cardiac function with sodium thiosulfate after ST-segment elevation myocardial infarction
    Groningen Interventiestudie voor de preservatie van de hartfunctie met natriumthiosulfate na ST-segmentelevatie myocardinfarct
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Groningen intervention study for the protection of heart function after a heart attack
    Groningen Interventiestudie voor de bescherming van de hartfunctie na een hartaanval
    A.3.2Name or abbreviated title of the trial where available
    GIPS-IV
    GIPS-IV
    A.4.1Sponsor's protocol code number2015C104
    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 Groningen (UMCG)
    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 supportUMCG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointCardioResearch
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503616161
    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 nameSodium thiosulfate pentahydrate
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium thiosulfate pentahydrate
    D.3.9.1CAS number 10102-17-7
    D.3.9.3Other descriptive nameSODIUM THIOSULFATE PENTAHYDRATE
    D.3.9.4EV Substance CodeSUB22204
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ST-segment elevated myocardial infarction, decompensatio cordis
    ST-segmentelevatie myocardinfarct, decompensatio cordis
    E.1.1.1Medical condition in easily understood language
    heart attack, heart failure
    hartaanval, hartfalen
    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 primary objective of the GIPS-IV is to evaluate the efficacy of sodium thiosulfate treatment compared to placebo on top of optimal reperfusion therapy for STEMI on myocardial infarct size 4 months after randomization as measured with late gadolinium enhancement cardiac magnetic resonance imaging (CMR-imaging).
    Het evalueren van de effectiviteit van natriumthiosulfaat in vergelijking met placebobehandeling, als aanvulling op optimale reperfusie therapie,
    bij patienten met een acuut myocardinfarct op infarctgrootte gemeten met MRI-onderzoek 4 maanden na randomisatie.
    E.2.2Secondary objectives of the trial
    Secondary CMR-imaging efficacy measures include left ventricular ejection fraction (LVEF) and myocardial perfusion reserve (MPR) at 4 month follow up. Furthermore, N-terminal fragment brain natriuretic peptide (NT-proBNP) will be assessed 4 months after randomisation. Other secondary efficacy endpoint measures will be obtained from non-mandatory CMR-imaging during hospitalization to study myocardial haemorrhage, microvascular obstruction (MVO) and myocardial salvage index (MSI). Clinical safety endpoints include all-cause mortality and combined incidence of cardiovascular events: cardiovascular death, re-infarction, re-intervention and stroke. As additional safety endpoints we will evaluate the incidence of internal cardiac defibrillator (ICD) implantation and hospitalization for heart failure or chest pain. Finally, enzymatic infarct size as assessed by peak creatine kinase, muscle-brain isoenzymes (CK)-MB) during hospitalization will be used as very early safety parameter.
    Secundaire CMR-beeldvorming effectiviteit-uitkomstmaten zijn linkerventrikel ejectiefractie (LVEF) en myocardiaal perfusie reserve (MPR), beide na 4 maanden. Op 4 maanden wordt tevens N-terminal fragment brein natriurisch peptide (NT-proBNP) gemeten. Andere secundaire effectiviteit-uitkomstmaten worden verkregen uit niet-verplichte CMR-beeldvorming tijdens hospitalisatie om myocardiale bloeding, microvasculaire obstructie en de myocardiale reddingsindex te beoordelen. Klinische veiligheidseindpunten omvatten mortaliteit van elke oorzaak en de gecombineerde incidentie van cardiovasculaire events: cardiovasculaire dood, re-infarct, re-interventie en beroerte. Als additionele veligheidsuitkomstmaten evalueren we de incidentie van interne cardiale defibrillator-implantatie en hospitalisatie voor hartfalen of pijn op de borst. Tot slot wordt het CK-MB tijdens hospitalisatie gebruikt als zeer vroege veiligheidsparameter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years;
    2. The diagnosis STEMI defined by (1) chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and (2) an electrocardiogram recording with ST- segment elevation of more than 0.1 mV in 2 or more contiguous leads or new left bundle branch block;
    3. Symptoms and/or ST-segment deviation should be present (persisting) at time of arrival in the catheterization laboratory;
    4. Primary percutaneous intervention is being considered as treatment;
    5. Patient is willing to cooperate with follow-up during 2 years.
    1. Leeftijd ≥ 18 jaar;
    2. De diagnose STEMI gedefinieerd als (1) pijn op de borst typisch voor myocardischemie voor ten minste 30 minuten, aanvang van klachten is minder dan 12 uur voor ziekenhuisopname, en (2) een elektrocardiogram met ST-segmentelevatie van meer dan 0.1mV in 2 of meer aanliggende afleidingen of nieuw linker bundeltakblok;
    3. Symptomen en/of ST-segmentafwijkingen zijn (nog steeds) aanwezig bij aanvang op de hartkatheterisatie;
    4. Primaire percutane coronaire interventie wordt overwogen als behandelmethode;
    5. Patient is bereid om mee te doen aan de follow-up gedurende twee jaar.
    E.4Principal exclusion criteria
    1. Prior myocardial infarction, unless maximum troponin T< 50 ng/L (STEMI/non-STEMI/acute coronary syndrome);
    2. Known permanent atrial fibrillation;
    3. Prior CABG;
    4. Prior PCI, complicated by periprocedural infarction, unless maximum troponin T < 50ng/L;
    5. Known cardiomyopathy;
    6. Previous hospitalization for heart failure
    7. Active malignancy (requiring chemotherapy, radiation or surgery at the time of randomization), except for adequately treated non-melanoma skin cancer or other noninvasive or in situ neoplasm (e.g., cervical cancer in situ);
    8. History of chemotherapy;
    9. History of radiotherapy in chest region;
    10. Relieve of symptoms and complete ST-segment resolution prior to arrival at the catheterization laboratory;
    11. Presentation with cardiogenic shock (systolic blood pressure < 90 mmHg);
    12. Severe hypertension (systolic blood pressure > 220 mmHg);
    13. Sedated and/or intubated patients;
    14. The existence of a condition with a life expectancy of less than 1 year;
    15. Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >;150kg; known claustrophobia; 3T MRI incompatible ferromagnetic objects in the body, end-stage renal disease);
    16. Pregnancy or breastfeeding women; women of childbearing potential with clinical suspicion of possible pregnancy;
    17. A condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to successfully participate in the study.
    1. Eerder myocardinfarct, tenzij maximaal troponine T< 50ng/L (STEMI/non-STEMI/acuut coronair syndroom);
    2. Bekend permanent boezemfibrilleren;
    3. CABG in de voorgeschiedenis;
    4. Eerdere PCI, gecompliceerd door periprocedureel infarct, tenzij maximaal troponine T < 50ng/L;
    5. Bekende cardiomyopathie;
    6. Opname vanwege hartfalen in de voorgeschiedenis;
    7. Actieve maligniteit (die chemotherapie, radiotherapie of operatie behoeft ten tijde van randomisatie), met uitzondering van adequaat behandelde non-melanoma huidkanker of adequaat behandeld carcinoom in situ;
    8. Behandeling met chemotherapie in de voorgeschiedenis;
    9. Voorgeschiedenis van bestraling in de thorax regio;
    10. Verdwijnen van symptomen en compleet herstel van ST-segmentafwijkingen voor aankomst op de hartkatheterisatiekamer;
    11. Presentatie met cardiogene shock (systolische bloeddruk < 90mmHg);
    12. Ernstige hypertensie (systolische bloeddruk > 220mmHg);
    13. Gesedeerde en/of geintubeerde patienten;
    14. Het bestaan van een aandoening met een levensverwachting van minder dan 1 jaar;
    15. Contra-indicaties voor 3 Tesla CMR-beeldvorming (o.a. lichaamsgewicht>150kg, claustrofobie; 3T MRI incompatibele ferromagnetische objecten in het lichaam, eindstadium nierfalen);
    16. Zwangere of borstvoeding gevende vrouwen; vrouwen in de vruchtbare levensfase met een klinische verdenking op een mogelijke zwangerschap;
    17. Een aandoening die, volgens de klinische blik van de onderzoeker en/of behandelend arts, er voor zorgt dat patient niet succesvol mee kan werken aan de studie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is myocardial infarct size as measured with LGE CMR-imaging at 4 months after randomization.
    Het primaire eindpunt is infarctgrootte gemeten met cardiale magnetische resonantie beeldvorming (CMR-beeldvorming) 4 maanden na randomisatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months after randomization
    4 maanden na randomizatie
    E.5.2Secondary end point(s)
    Efficacy:
    - LVEF as assessed by CMR-imaging at 4 months follow-up;
    - Myocardial perfusion reserve, assessed with rest and stress CMR imaging at 4 months follow-up;
    - NT pro-BNP at 4 months follow-up;
    - Other CMR-imaging parameters obtained from non-mandatory CMR-imaging during hospitalization and CMR-imaging at 4 months, including myocardial haemorrhage, MVO, MSI, LVEF, LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV) and LV mass;

    Safety:
    - Incidence of cardiovascular events within 4 months and after 2-year follow-up (all cause mortality, cardiovascular death, re-infarction, re-intervention both re-PCI and CABG [except for scheduled revascularization based on the index CAG to diagnose and treat coronary artery lesions identified during the procedures and heart team discussion, including concomitant treatment of valvular conditions, see 9.2.2 disease related adverse events], stroke, ICD implantation, hospitalization for heart failure or chest pain (defined as an overnight stay, with different dates for admission and discharge) and combined endpoints MACE defined as death, re-infarction, any revascularization not planned on index CAG) (see Table 1);
    - A division between cardiac and non-cardiac death is made, with a subdivision in cardiac death, namely heart failure, sudden cardiac death and other. Cardiovascular death will be confirmed by a cardiologist by examining medical records obtained from attending physicians and hospitals or general practitioners if patient died at home. Sudden cardiac death is either defined as witnessed, un-witnessed, cardiac arrest without evidence of circulatory collapse, such as hypotension, exacerbation of congestive heart failure, or altered mental status, before the disappearance of the pulse or abrupt collapse occurring within one hour of the onset of the symptoms that resulted in death. Death due to heart failure will be defined as death due to clinically end-stage heart failure during hospital admission or by exacerbation of congestive heart failure reported by an attending general practitioner. For all these deaths, no probable non-cardiac cause should be suggested by the history or autopsy;
    - Enzymatic infarct size as assessed by peak CK-MB during hospitalization.
    Secundaire CMR-beeldvorming effectiviteit-uitkomstmaten zijn linkerventrikel ejectiefractie (LVEF) en myocardiaal perfusie reserve (MPR), beide na 4 maanden. Op 4 maanden wordt tevens N-terminal fragment brein natriurisch peptide (NT-proBNP) gemeten. Andere secundaire effectiviteit-uitkomstmaten worden verkregen uit niet-verplichte CMR-beeldvorming tijdens hospitalisatie om myocardiale bloeding, microvasculaire obstructie en de myocardiale reddingsindex te beoordelen.

    Klinische veiligheidseindpunten omvatten mortaliteit van elke oorzaak en de gecombineerde incidentie van cardiovasculaire events: cardiovasculaire dood, re-infarct, re-interventie en beroerte. Als additionele veligheidsuitkomstmaten evalueren we de incidentie van interne cardiale defibrillator-implantatie en hospitalisatie voor hartfalen of pijn op de borst. Tot slot wordt het CK-MB tijdens hospitalisatie gebruikt als zeer vroege veiligheidsparameter.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months after randomization and after 2 years follow-up
    4 maanden na randomizatie en na 2 jaar follow-up
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 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 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
    the last visit of the last subject undergoing the trial
    laatste studievisite van de laatste proefpersoon die deelneemt aan de trial
    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 months
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 380
    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 state380
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    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 Decision2016-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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