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    Clinical Trial Results:
    Triiodothyronine for repair of left ventricular dysfunction and Remodeling in STEMI Patients

    Summary
    EudraCT number
    		 2016-000631-40
    Trial protocol
    		 GR  
    Global end of trial date
    12 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 May 2022
    First version publication date
    07 May 2022
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    T3inj-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA
    Sponsor organisation address
    14th Km National Road 1, Kifissia, Greece, 14564
    Public contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 30 2108072512, soumelas@uni-pharma.gr
    Scientific contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 0030 2108072512, soumelas@uni-pharma.gr
    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
    17 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective will be the assessment of myocardial function by CMR after administration of liothyronine in patients with anterior or anterolateral STEMI.
    Protection of trial subjects
    Νo specific measures applied
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2016
    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
    Greece: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    52
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was admitted to the study on 13.11.2016 and the last on 12.11.2020. 155 patients were admitted to the centers and a total of n = 52 patients were finally enrolled, in 2 centers: 1. Cardiology Department, ELPIS General Hospital of Athens, Greece 2. Cardiology Department of Tzaneio General Hospital of Athens, Greece.

    Pre-assignment
    Screening details
    		 Patients (18 <Age≤75 years old) with anterior or anterolateral ST-Elevation Myocardial Infarctionwho presented within 12 hours after the onset of chest pain and were subjected to successful primary PCI.

    Period 1
    Period 1 title
    Start of treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    In order to maintain blindness identical packs with identically appearing contents were used for both placebo and drug administration. The investigator site personnel involved in the monitoring or conducting of the trial was blinded to the trial drug codes. Trial drug codes were not available to the above personnel except in the case of an emergency. All serum samples for thyroid hormone measurements were collected and analyzed at the end of the trial in order not to break the blindness.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Composition identical to the experimental drug apart from the active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Arm title
    		 T3 inj sol
    Arm description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    T3®Solution for injection 10μg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Number of subjects in period 1
    		Placebo T3 inj sol
    Started
    24
    28
    Completed
    24
    28
    Period 2
    Period 2 title
    Discharge
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In order to maintain blindness identical packs with identically appearing contents were used for both placebo and drug administration. The investigator site personnel involved in the monitoring or conducting of the trial was blinded to the trial drug codes. Trial drug codes were not available to the above personnel except in the case of an emergency. All serum samples for thyroid hormone measurements were collected and analyzed at the end of the trial in order not to break the blindness.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Composition identical to the experimental drug apart from the active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Arm title
    		 T3 inj sol
    Arm description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    T3®Solution for injection 10μg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Number of subjects in period 2
    		Placebo T3 inj sol
    Started
    24
    28
    Completed
    22
    24
    Not completed
    2
    4
         Adverse event, serious fatal
    -
    1
         Protocol deviation
    2
    3
    Period 3
    Period 3 title
    3 months visit
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In order to maintain blindness identical packs with identically appearing contents were used for both placebo and drug administration. The investigator site personnel involved in the monitoring or conducting of the trial was blinded to the trial drug codes. Trial drug codes were not available to the above personnel except in the case of an emergency. All serum samples for thyroid hormone measurements were collected and analyzed at the end of the trial in order not to break the blindness.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Composition identical to the experimental drug apart from the active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Arm title
    		 T3 inj sol
    Arm description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    T3®Solution for injection 10μg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Number of subjects in period 3
    		Placebo T3 inj sol
    Started
    22
    24
    Completed
    21
    22
    Not completed
    1
    2
         Adverse event, serious fatal
    1
    1
         Lost to follow-up
    -
    1
    Period 4
    Period 4 title
    6 months visit
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In order to maintain blindness identical packs with identically appearing contents were used for both placebo and drug administration. The investigator site personnel involved in the monitoring or conducting of the trial was blinded to the trial drug codes. Trial drug codes were not available to the above personnel except in the case of an emergency. All serum samples for thyroid hormone measurements were collected and analyzed at the end of the trial in order not to break the blindness.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Composition identical to the experimental drug apart from the active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Arm title
    		 T3 inj sol
    Arm description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    T3®Solution for injection 10μg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose administered was 0.8mcg.kg-1 intravenously bolus starting at reperfusion followed by an infusion of 0.113mcg. kg-1.h-1 intravenously for 48 hours. The selection of the dose and duration of treatment was based on preclinical and clinical evidence, adjusted for patient body weight.

    Number of subjects in period 4
    		Placebo T3 inj sol
    Started
    21
    22
    Completed
    21
    21
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Start of treatment
    Reporting group description
    		 -

    Reporting group values
    		 Start of treatment Total
    Number of subjects
    		 52 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 52 52
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.1 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 48 48

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Composition identical to the experimental drug apart from the active substance.

    Reporting group title
    T3 inj sol
    Reporting group description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Reporting group title
    Placebo
    Reporting group description
    		 Composition identical to the experimental drug apart from the active substance.

    Reporting group title
    T3 inj sol
    Reporting group description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Reporting group title
    Placebo
    Reporting group description
    		 Composition identical to the experimental drug apart from the active substance.

    Reporting group title
    T3 inj sol
    Reporting group description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.
    Reporting group title
    Placebo
    Reporting group description
    		 Composition identical to the experimental drug apart from the active substance.

    Reporting group title
    T3 inj sol
    Reporting group description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.

    Primary: LVMI at 6 months

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    End point title
    		 LVMI at 6 months [1]
    End point description
    Left Ventricular Mass Index
    End point type
    Primary
    End point timeframe
    6 months after acute myocardial infarction
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 Placebo T3 inj sol
    Number of subjects analysed
    16 [2]
    21
    Units: gram(s)/square metre
        arithmetic mean (standard deviation)
    58.8 ( 13.9 )
    52.4 ( 7.5 )
    Notes
    [2] - 1 patient not subjected to CMR due to claustrophobia, 4 excluded due to minimal infarct size
    No statistical analyses for this end point

    Primary: LVEDVI at 6 months

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    End point title
    		 LVEDVI at 6 months [3]
    End point description
    Left Ventricular End-Diastolic Volume Index
    End point type
    Primary
    End point timeframe
    6 months after acute myocardial infarction
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 Placebo T3 inj sol
    Number of subjects analysed
    16 [4]
    21
    Units: millilitre(s)/square m
        arithmetic mean (standard deviation)
    110 ( 32 )
    94.7 ( 17 )
    Notes
    [4] - 1 patient not subjected to CMR due to claustrophobia, 4 excluded due to minimal infarct size
    No statistical analyses for this end point

    Primary: LVESVI

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    End point title
    		 LVESVI [5]
    End point description
    Left Ventricular End-Systolic Volume Index
    End point type
    Primary
    End point timeframe
    6 months after acute myocardial infarction
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 Placebo T3 inj sol
    Number of subjects analysed
    16 [6]
    21
    Units: millilitre(s)/square m
        arithmetic mean (standard deviation)
    59 ( 31.6 )
    44.9 ( 15.3 )
    Notes
    [6] - 1 patient not subjected to CMR due to claustrophobia, 4 excluded due to minimal infarct size
    No statistical analyses for this end point

    Primary: LVEF, %

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    End point title
    		 LVEF, % [7]
    End point description
    percent of Left Ventricular Ejection Fraction
    End point type
    Primary
    End point timeframe
    6 months after acute myocardial infarction
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 Placebo T3 inj sol
    Number of subjects analysed
    16 [8]
    21
    Units: percent
        arithmetic mean (standard deviation)
    48.6 ( 11 )
    53.6 ( 9.5 )
    Notes
    [8] - 1 patient not subjected to CMR due to claustrophobia, 4 excluded due to minimal infarct size
    No statistical analyses for this end point

    Primary: Infarct Size

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    End point title
    		 Infarct Size [9]
    End point description
    End point type
    Primary
    End point timeframe
    6 months after acute myocardial infarction
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 Placebo T3 inj sol
    Number of subjects analysed
    16 [10]
    21
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    25.9 ( 11.7 )
    18.7 ( 9.5 )
    Notes
    [10] - 1 patient not subjected to CMR due to claustrophobia, 4 excluded due to minimal infarct size
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months after acute myocardial infarction
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Composition identical to the experimental drug apart from the active substance.

    Reporting group title
    T3 inj sol
    Reporting group description
    		 T3®Solution for injection 10μg/ml, having Liothyronine sodium as active substance, at the strength of 10μg/ml.

    Serious adverse events
    		 Placebo T3 inj sol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 22 (31.82%)
    16 / 26 (61.54%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Left ventricular failure
    Additional description: LV thrombus formation
         subjects affected / exposed
    6 / 22 (27.27%)
    4 / 26 (15.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 22 (4.55%)
    5 / 26 (19.23%)
         occurrences causally related to treatment / all
    0 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
    Additional description: Pericarditis related to acute myocardial infarction
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Pyrexia
    Additional description: Transient episodes of increased temperature >37.8°C
         subjects affected / exposed
    2 / 22 (9.09%)
    8 / 26 (30.77%)
         occurrences causally related to treatment / all
    0 / 2
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo T3 inj sol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 22 (22.73%)
    9 / 26 (34.62%)
    Vascular disorders
    Haemorrhage
    Additional description: Minor episodes of nose bleeding
         subjects affected / exposed
    3 / 22 (13.64%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Nervous system disorders
    Nervousness
    Additional description: Nervousness during first 72h
         subjects affected / exposed
    2 / 22 (9.09%)
    6 / 26 (23.08%)
         occurrences all number
    2
    6

    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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