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    EudraCT Number:2013-001922-24
    Sponsor's Protocol Code Number:120541
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-09-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-001922-24
    A.3Full title of the trial
    The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised control trial investigating the effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)
    A.3.2Name or abbreviated title of the trial where available
    Investigation into the role of GTN & RIPC in cardiac surgery
    A.4.1Sponsor's protocol code number120541
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01864252
    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 College London (UCL)
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR UCL/UCLH Biomedical Research Centre
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRosetrees trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Hatter Cardiovascular Institute
    B.5.2Functional name of contact pointProf. Derek M Yellon
    B.5.3 Address:
    B.5.3.1Street Address67 Chenies Mews
    B.5.3.2Town/ cityLondon,
    B.5.3.3Post codeWC1E 6HX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number(0) 203 447 9888
    B.5.5Fax number(0) 203 447 9505
    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. name Glyceryl Trinitrate 1 mg/ml solution for infusion
    D. of the Marketing Authorisation holderHameln Pharma Plus gmbh
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGlyceryl Trinitrate 1 mg/ml solution for infusion
    D.3.2Product code GTN
    D.3.4Pharmaceutical form Solution for 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 INNGlyceryl TriNitrate
    D.3.9.1CAS number 55-63-0
    D.3.9.3Other descriptive nameNitroglycerin
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    We are investigating the phenomenon of ischaemic-reperfusion injury. Reperfusion of the ischaemic myocardium is known to cause further myocardial damage. We wish to investigate the phenomenon of Remote Ischaemic Preconditionoing along with Glyceryl Trinitrate to reduce reperfusion injury.
    E.1.1.1Medical condition in easily understood language
    Restarting blood supply to the heart muscle after it has been stopped is known to be associated with a certain degree of heart muscle damage. We wish to investigate means to reduce this damage.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10051624
    E.1.2Term Myocardial reperfusion injury
    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
    1. Does GTN administered as a continuous (intra-operative intravenous) infusion into a vein reduce injury to the heart muscle in patients undergoing heart-lung bypass Coronary Artery Bypass Graft (CABG) and/or valve surgery?

    2. Does RIPC reduce injury to the heart muscle in the presence of GTN administered as a continuous (intra-operative intravenous) infusion into a vein in patients undergoing heart-lung bypass CABG and/or valve surgery?
    E.2.2Secondary objectives of the trial
    1. Does RIPC or GTN reduce post-operative inotrope (drugs used to support the blood pressure) use?
    2. Does RIPC or GTN reduce ventilator dependence post operatively?
    3. Does RIPC or GTN reduce incidence of Acute Kidney Injury?
    4.Does RIPC or GTN reduce incidence of post-operative atrial fibrillation (rhythm disturbance to the heart which increases morbidity and mortality)?
    5. Does RIPC or GTN reduce length of ICU stay?
    6. Does RIPC or GTN reduce length of hospital stay?
    1. Does RIPC or GTN improve heart contractile function after the surgery?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Transthoracic echo sub-study Version 1 dated 31/1/2013: Observational pilot study examining the effect of RIPC and GTN on left ventricular ejection fraction.
    Objective - To collect pilot data through observations of any changes between baseline and post-operative left ventricular ejection fractions determined by trans-thoraic echocardiograms in patients who get routine echocardiograms pre-operatively post-operatively.
    E.3Principal inclusion criteria
    1.Adult patients (>18 years old) undergoing CABG and/or valve surgery involving cardiopulmonary bypass capable of consenting themselves.
    E.4Principal exclusion criteria
    1. Allergies to excipients of IMP and placebo
    2. Chronic Renal failure (eGFR<30 ml/min/kg)
    3. Severe liver disease
    4. Peripheral arterial disease
    5. Pregnant or lactating women
    6. Any other contraindications to glyceryl trinitrate as per the summary of product characteristics.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be cardiac high-sensitivity troponin T release 72 hours area-under-the-curve.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be collected at 0 hours, 6 hours, 12 hours, 24 hours, 48 hours and 72 hours. High sensitivity Troponin T levels will be determined at plotted as a curve against time. The area under the curve will be determined.
    E.5.2Secondary end point(s)
    i. Inotrope/Vasopressor requirements in the perioperative period
    The inotrope score will be calculated as follows:
    Dosages (in μg/kg/min) of [Dopamine + Dobutamine] + [(Adrenaline + Noradrenaline + Isoproterenol + Isoproterenol) x 100] + [(Enoximone + Milrinone) x 15]

    ii. Ventilator dependence post operatively.
    The duration of endotracheal intubation will be noted in hours. Re-intubation rates will be calculated by noting down the number of patients requiring re-intubation and comparing this amongst the 4 groups.
    iii. Incidence of Acute Kidney Injury assessed using biomarkers (Creatinine).
    Serum creatinine levels will be noted in the first 3 days postoperatively. If a patient requires renal replacement therapy, this will be recorded and comparisons made amongst the groups. Hourly urine output and daily urine volumes for the duration of ITU stay will be recorded.
    iv. Incidence of post-operative atrial fibrillation.
    Atrial fibrillation will be diagnosed using ECG. A record of the number of patients developing AF post operatively, the intervention used to treat it and whether or not the patient reverted to sinus rhythm prior to ITU discharge will be documented.
    v. Length of ICU stay.
    A record of stay in days will be noted.
    vi. Length of hospital stay
    A record of stay in days will be noted.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Discussed above
    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. 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 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 Yes
    E. description
    Sham RIPC protocol
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Discharge of the last recruited patient from the hospital.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 260
    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)
    All interventions will be during the study period only. The interventions are not clinically needed after the study period as they have no proven benefit. After the study period all treatment will be standard post-operative care.

    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 Decision2013-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-12
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