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    Clinical Trial Results:
    The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.

    Summary
    EudraCT number
    		 2007-002931-95
    Trial protocol
    		 BE   DE   HU  
    Global end of trial date
    01 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2024
    First version publication date
    15 Mar 2024
    Other versions
    Summary report(s)
    		 NOMI publication

    Trial information

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    Trial identification
    Sponsor protocol code
    LCC2010.01102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01398384
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, LEUVEN, Belgium, 3000
    Public contact
    Stefan Janssens, UZ Leuven, 32 16344246, stefan.janssens@uzleuven.be
    Scientific contact
    Stefan Janssens, UZ Leuven, 32 16344246, stefan.janssens@uzleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    See protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    Belgium: 93
    Country: Number of subjects enrolled
    Hungary: 100
    Worldwide total number of subjects
    249
    EEA total number of subjects
    249
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    155
    From 65 to 84 years
    84
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patient must meet the following inclusion 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 > or = to 0.6 mV in leads I, II, III, AVL, AVF, V1-V6

    Pre-assignment
    Screening details
    		 The patient must meet the following inclusion 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 > or = to 0.6 mV in leads I, II, III, AVL, AVF, V1-V6

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nitric oxide
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nitric oxide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    80 ppm nitric oxide, 4 h inhalation

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    nitrogen gas
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    80 ppm nitrogen gas, 4h inhalation

    Number of subjects in period 1
    		Nitric oxide Placebo
    Started
    122
    127
    Completed
    122
    127

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nitric oxide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Nitric oxide Placebo Total
    Number of subjects
    		 122 127 249
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63 ± 13 60 ± 11 -
    Gender categorical
    Units: Subjects
        Female
    		 44 33 77
        Male
    		 78 94 172

    End points

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    End points reporting groups
    Reporting group title
    Nitric oxide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    The primary efficacy objective was myocardial infarction size as percentage of left ventricular mass at 48–72 h after randomisation measured using magnetic resonance imaging (MRI).
    End point type
    Primary
    End point timeframe
    48–72 h after randomisation
    End point values
    		 Nitric oxide Placebo
    Number of subjects analysed
    109
    116
    Units: MI size / LV mass (%)
        arithmetic mean (standard deviation)
    18.0 ± 13.4
    19.4 ± 15.4
    Statistical analysis title
    		 Myocardial Infarction Size as a Fraction of Left V
    Comparison groups
    Nitric oxide v Placebo
    Number of subjects included in analysis
    225
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 2.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48-72 hours and 4 months
    Adverse event reporting additional description
    Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Nitric oxide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Nitric oxide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 122 (7.38%)
    5 / 127 (3.94%)
         number of deaths (all causes)
    5
    8
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    left heart failure
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular fibrillation
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiogenic shock
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    ventricular tachycardia
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    total AV block
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stenosis
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nitric oxide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 122 (9.02%)
    11 / 127 (8.66%)
    Vascular disorders
    Ischaemia
         subjects affected / exposed
    11 / 122 (9.02%)
    11 / 127 (8.66%)
         occurrences all number
    11
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29800130
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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