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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-023211-34
    Sponsor's Protocol Code Number:
    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:2011-02-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-023211-34
    A.3Full title of the trial
    Randomized Controlled Trial Comparing Intracoronary Administration
    of Adenosine or Sodium Nitroprusside to Control for Attenuation of Microvascular
    Obstruction During Primary Percutaneous Coronary Intervention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MVO Study
    A.3.2Name or abbreviated title of the trial where available
    MVO 09/150/28
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospitals of Leicester NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 AuthorisationUnited Kingdom
    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 nameAdenosine
    D.3.2Product code NA
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdenosine
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3 to 1
    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 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 Nitroprussiat Fides
    D.2.1.1.2Name of the Marketing Authorisation holderRottapharm
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Nitroprusside
    D.3.2Product code NA
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Nitroprusside
    D.3.9.1CAS number 13755-38-9
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute ST-segment Elevation Myocardial Infarction
    E.1.1.1Medical condition in easily understood language
    Heart attack where the coronary artery is completely blocked off by the blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to die.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041894
    E.1.2Term ST segment elevation
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal objective of our proposed study is to determine:-
    1) Whether adjunctive medical treatment given via a very small tube placed beyond the blockage downstream in the affected heart attack artery at time of angioplasty for heart attack and following blood clot removal from the heart vessel, reduces downstream small blood vessel obstruction and heart muscle damage size as determined by using CMR scanners.
    The principal study question is:
    1) How might we attenuate small blood vessel obstruction and thus reduce heart attack size in patients undergoing angioplasty for heart attack?
    E.2.2Secondary objectives of the trial
    The secondary objectives of our proposed study are to determine:-
    1) Whether there is a difference between the small downstream artery dilating drugs -adenosine and sodium nitroprusside in their ability to reduce small blood vessel obstruction and heart muscle damage size determined using CMR scanners, both given via a very small tube (catheter) placed beyond the blockage in the downstream affected heart artery.
    2) The correlation of markers of poor blood flow in heart vessels as determined by the flow seen on the angiogram, with CMR detected small blood vessel obstruction and heart muscle damage, as well as with clinical outcome at six months.
    The secondary study questions are:
    1) Should all,some or no patients receive adjunctive therapies (adenosine / sodium nitroprusside) given via a small tube (catheter) to reduce small downstream blood vessel obstruction routinely in addition to the standard current treatment of blood clots removal(aspiration) from the heart's artery and if so
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:Assessment of platelet activation and inflammation during the procedures. See Full protocol Version 5, Date: 04/11/11, Page 14.

    This mechanistic sub-study will be carried out on patients entered into the study at Glenfield hospital (Leicester), and will be performed in Professor Goodall’s laboratory by the Clinical Fellow, using established methods, and with support from experienced technical staff.

    Objective: Small samples of blood (≤2ml) will be taken from the patients to assess the effect of these short lived treatment agents on platelet activation within the coronary circulation.


    E.3Principal inclusion criteria
    • ≥ 18 years age with written informed ASSENT prior to angiography. (ASSENT is being used following Ethical Committee approval in another trial run by University Hospitals of Leicester- The STREAM study).
    • ST – segment elevation myocardial infarction (STEMI) ≤ 6 hrs of symptom onset requiring primary reperfusion by PCI.
    • Single-vessel and coronary artery disease (non culprit disease ≤70% stenosis at angiography) to avoid bias which may occur in analysis of microvascular obstruction (MVO) and infarct size if intervention should be undertaken in more than one vessel.
    • TIMI flow 0/I at angiography.
    E.4Principal exclusion criteria
    • Any exclusion criteria for primary percutaneous coronary intervention (P-PCI) (see below).
    • Previous Q wave myocardial infarction.
    • Contraindications to cardiac MRI contrast agents, or study medications: Aspirin, Prasugrel, Bivalirudin.
    • Cardiogenic Shock or systolic blood pressure ≤ 90mmHg needing intraortic balloon pump.
    • Culprit lesion located in a by-pass graft.
    • Culprit lesion non identified.
    • Stent thrombosis.
    • Left main disease.
    • Known severe asthma.
    • Known stage 4 or 5 chronic kidney disease (eGFR<30ml/min).
    • Pregnancy.
    Exclusion criteria for P-PCI: presentation timing, inadequate arterial access, patient unable to tolerate PCI procedure(in operators’ opinion).
    Absolute contra-indication to cardiac MRI (Pacemaker, Implantable cardiac defibrillator, intra-cranial metal clips).
    E.5 End points
    E.5.1Primary end point(s)
    Cardiac magnetic resonance (CMR) measured infarct size (%LV mass) at 48-72 hours post procedure. Infarct size has been chosen rather than the microvascular obstruction (MVO) as the primary end point since there is a wealth of published data on infarct size following P-PCI. We are also uncertain as to the expected size of effect on MVO (incidence and absolute reduction in MVO as % of LV mass) of both sodium nitroprusside and adenosine. MVO and infarct size measured on CMR are closely inter-related and are both important predictors of prognosis.
    E.5.2Secondary end point(s)
    1. CMR incidence and extent of MVO (% LV mass)at 48-72 hours post procedure.
    2. CMR measured myocardial salvage index, haemorrhage, LV EF and volumes in the acute stage.
    3. Angiographic markers of MVO including the recently designed computer-assisted myocardial blush quantification ‘Quantitative Blush Evaluator’ (QuBE)(83). (Assessed by two interventional cardiologists blinded to treatment arm).
    4. Incidence pre and post procedure angiographic true “no-reflow”.
    5. Incidence of angiographic slow/no-reflow after PCI with the three different management strategies.
    6. Any in-patient clinical events (re-occlusion), need for repeat PCI, recurrent chest pain with new ECG changes, incidence of clinical heart failure (symptoms plus basal crackles plus X-ray evidence pulmonary congestion) proven cerebrovascular accident (CVA).
    7. Overall MACCE and its components at 6 months: namely death, need for TLR, recurrent MI, severe heart failure, and CVA.
    8. Comparing CMR markers with other myocardial perfusion markers: angiographic (TIMI grade CTFC, MBG, and computer-assisted myocardial blush quantification), ECG (ST segment resolution) and cardiac enzymes.
    9. Degree of ST resolution.
    10. Echocardiography assessment of LV (EDV, ESV and EF) at 8-12 weeks during a routine follow up visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard clinical care
    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 concerned2
    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
    last patient last visit / telephone interview
    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 days0
    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 days0
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 149
    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 state297
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 297
    F.4.2.2In the whole clinical trial 297
    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)
    The interventions undertaken in this trial are given acutely to the patient very early in their management and other than follow up via telephone at 6 months, no further intervention needs arranging. Should the participants require further healthcare advice or treatment this would be provided as per standard care i.e. GP
    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 Decision2011-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-01-23
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