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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002931-95
    Sponsor's Protocol Code Number:LCC2010.01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-08
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-002931-95
    A.3Full title of the trial
    The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is breathing a new medical gas better than oxigen in protecting your heart after a heart attack?
    A.3.2Name or abbreviated title of the trial where available
    NOMI
    A.4.1Sponsor's protocol code numberLCC2010.01
    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 SponsorUZ Leuven
    B.1.3.4CountryBelgium
    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 supportInstitute for Science and Technology
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointLeuven Coordinating Centre
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216342114
    B.5.5Fax number3216342100
    B.5.6E-mailkatleen.vandenberghe@uzleuven.be
    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 VASOkinox 450 ppm (nitric oxide) for inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquide Santé International
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameVASOkinox 450 ppm (nitric oxide) for inhalation
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Inhalation gas
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnitric oxide
    D.3.9.1CAS number 10102-43-9
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit PPM part per million
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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 Yes
    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 placeboInhalation gas
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial Infarction
    E.1.1.1Medical condition in easily understood language
    Acute heart attack
    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 PT
    E.1.2Classification code 10028596
    E.1.2Term 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 primary objective of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are to assess impact of NO inhalation on:
    1. MI size at 48–72 h (MRI).
    2. MI size normalized to area at risk at 48–72 h (MRI).
    3. Myocardial perfusion after PCI.
    4. MI transmurality at 48–72 h and 4 months.
    5. Myocardial perfusion at 48-72 h and 4 months (MRI).
    6. Global & regional left ventricular (LV) function and LV mass at 48–72 h and 4 months after MI. MI size as a fraction of LV size at 4 months after MI.
    7. Resolution of ST segment elevation at 4 h compared to enrollment.
    8. Troponin T levels & CPK-MB area under the curve at 48 h.
    9. Change between 48-72 h and 4 months in LV end-diastolic volume; end-systolic volume; end-diastolic myocardial wall thickness in infarct, peri-infarct & remote areas; & sphericity index at end-diastole & end-systole.
    10. Death; nonfatal recurrent MI; recurrent ischemia necessitating re-hospitalization, PCI, or surgical revascularization; & stroke at 4 months.
    11. Safety-determined by reported AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient must meet the following criteria:
    1. Acute myocardial infarction (defined as an episode of chest pain or related symptom lasting greater than 2 hours but less than 12 hours and electrocardiographic evidence of ST elevation (measured as 0.08 seconds after the J point; sum >= 0.6 mV in leads I, II, III, AVL, AVF, V1-V6).
    2. No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC.
    3. Age > 18 years.
    4. Signed EC approved informed consent.
    E.4Principal exclusion criteria
    The patient will be excluded from enrollment if any of the following are true:
    1. Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease.
    2. Requirement for urgent cardiac surgery.
    3. Previous CABG or PCI.
    4. Left bundle branch block.
    5. Unable to tolerate magnetic resonance imaging (including disallowed metallic implants or BMI > 35) or unable to tolerate gadolinium contrast media, including patients with calculated creatinine clearance less than 60 ml/min/1.73 m2 BSA.
    6. Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion within 6 weeks prior to presentation or hemorrhagic stroke within the 6 weeks prior to presentation.
    7. Known or suspected aortic dissection.
    8. Prior history of pulmonary disease requiring chronic oxygen therapy.
    9. Pregnancy, lactating and woman of childbearing potential.
    10. Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed.
    11. Medical problem likely to preclude completion of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for this study will be myocardial infarction size as a fraction of left ventricular size as measured by contrast-enhanced cardiac MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 48-72 hours
    E.5.2Secondary end point(s)
    1. MI size, extent and transmurality of microvascular obstruction at 48 –
    72 hours (MRI).
    2. MI size normalized to area at risk at 48 – 72 hours (MRI).
    3. Myocardial perfusion at coronary angiography at the completion of
    PCI (corrected TIMI frame count and myocardial blush grade).
    4. Infarct transmurality (as average percent wall thickness in all
    segments showing delayed enhancement) at 48 – 72 hours and 4
    months.
    5. Myocardial perfusion at 48 – 72 hours and 4 months (MRI).
    6. Global and regional left ventricular function and left ventricular mass
    at 48 – 72hours and 4 months after MI, and the change in global LV
    function and mass between 48 – 72 hours and 4 months. MI size as a
    fraction of LV size at4 months after MI.
    7. Resolution of ST segment elevation (serial ECGs) as indicated by the
    decrease in the total ST elevation (in mV) at 4 hours compared with that
    observed at enrollment.
    8. Troponin T levels and CPK-MB area under the curve at 48 hours.
    9. Change in adverse remodeling parameters at 4 months (compared
    with 48 – 72 hours): changes in LV end-diastolic volume, end-systolic
    volume, end-diastolic myocardial wall thickness in infarct, peri-infarct
    and remote areas and in sphericity index at end-diastole and endsystole.
    10. Incidence of death; nonfatal recurrent myocardial infarction;
    recurrent ischemia necessitating re-hospitalization, PCI, or surgical
    revascularization; and stroke (i.e. combined CV endpoint) at 4 months.
    Enzyme leak during subsequent scheduled PCI will not be considered
    new ischemia/MI.
    11. Assess the safety of inhaled NO for this use as determined by
    reported adverse events (including bleeding and laboratory changes).
    E.5.2.1Timepoint(s) of evaluation of this end point
    48-72 hours and at 4 months
    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 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    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
    --
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 230
    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
    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 Decision2007-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-01
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