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    Clinical Trial Results:
    Intracoronary administration of melatonin for patients with acute myocardial infarction: a placebo controlled randomized study.

    Summary
    EudraCT number
    		 2010-022400-53
    Trial protocol
    		 DK  
    Global end of trial date
    28 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NLH-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sjællands Universitetshospital
    Sponsor organisation address
    Lykkebækvej 1, Køge, Denmark,
    Public contact
    Ismail Gögenur, Sjællands Universitetshospital, 0045 47323012, igo@regionsjaelland.dk
    Scientific contact
    Ismail Gögenur, Sjællands Universitetshospital, 0045 47323012, igo@regionsjaelland.dk
    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
    01 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    MRI to examine myocardial infarct size, area at risk and myocardial salvage index. MRI is to be performed on day 4 (+/-1).
    Protection of trial subjects
    questionnaire on dizziness, konfusion, depression and headache
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    28
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on the 1st of juni 2013. Patients admitted with an ST-elevation myocardial infarction were screened by the cardiologist and recruited in the cardiac lab prior to the acute myocardial reperfusion at Aalborg University Hospital.

    Pre-assignment
    Screening details
    		 A total of 526 patients were screened. The most important screening criteria: age > 18 years, STEMI ECG-criteria, one significant coronary occlusion (>2mm) with TIMI flow 0-1, PCI within 6 hours of symptom unset, being able to provide informed consent , no prior AMI, cardiogenic shock, and atrial fibrillation.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Melatonin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Melatonin
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intracoronary use, Intravenous use
    Dosage and administration details
    1 mg given as a bolus injection intracoronarily over 30-60 seconds 49 mg given intravenously over 6 hours

    Arm title
    		 Placebo
    Arm description
    		 Isotonic saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline, Natrium chloride
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracoronary use, Intravenous use
    Dosage and administration details
    500ml of isotonic saline

    Number of subjects in period 1
    		Melatonin Placebo
    Started
    24
    24
    Completed
    24
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Isotonic saline

    Reporting group values
    		 Melatonin Placebo Total
    Number of subjects
    		 24 24 48
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.7 ( 12 ) 64 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10
        Male
    		 20 18 38

    End points

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    End points reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Isotonic saline

    Primary: myocardial salvage index

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    End point title
    		 myocardial salvage index
    End point description
    End point type
    Primary
    End point timeframe
    Assessed at day 4 (+/- 1 day) from primary percutaneous coronary intervention
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    22
    19
    Units: %
    55
    62
    Statistical analysis title
    		 primary analysis
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were assessed for each patient from inclusion in the trial until 90 days after the inclusion. Period: 01.06.2013 - 01.06.2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Melatonin
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the subjects included experiences any adverse events (non-serious). We systematically screened for dizziness, headache, confusion and depression.
    Serious adverse events
    		 Placebo Melatonin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 24 (25.00%)
    6 / 24 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    5 / 24 (20.83%)
    6 / 24 (25.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    Additional description: Reinfarction after the primary treatment
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Melatonin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)

    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
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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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