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    Clinical Trial Results:
    CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 Antagonist, in Patients with Large Reperfused ST-Elevation Myocardial Infarction

    Summary
    EudraCT number
    		 2012-003229-91
    Trial protocol
    		 DE   GB   AT   HU   PL   CZ   NO   HR  
    Global end of trial date
    06 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2016
    First version publication date
    20 Aug 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    POL6326-POL-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01905475
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Polyphor AG
    Sponsor organisation address
    Hegenheimermattweg 125, Allschwil, Switzerland, 4123
    Public contact
    Dr. med. Klaus Dembowsky, Polyphor AG, +41 61567 1641, Klaus.Dembowsky@polyphor.com
    Scientific contact
    Dr. med. Klaus Dembowsky, Polyphor AG, +41 61567 1641, Klaus.Dembowsky@polyphor.com
    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
    20 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the effects of the CXCR4 antagonist POL6326 on cardiac function and infarct size in patients with large reperfused STEMI.
    Protection of trial subjects
    Independent Data Monitoring Committee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Austria: 24
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 43
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    82
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 213 patients were recruited for the study at 16 out of 25 initiated centres between August 2013 and August 2015. Of the 120 patients entered into the double-blind phase, 60 were randomised to receive POL6326 1.5 mg/kg and 60 to receive placebo.

    Pre-assignment
    Screening details
    		 This study included a pre-study and screening phase up to 4 days prior to the treatment phase. To help minimize screen failures, patients were to have had an assessment of their LV function during the pre-study phase to obtain a first estimate of LVEF following their PCI in line with the site's standard-of-care.

    Pre-assignment period milestones
    Number of subjects started
    		 213 [1]
    Number of subjects completed
    		 120

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Failure to meet inclusion criteria: 93
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 213 patients were recruited for the study, 93 were screen failures (failure to meet inclusion criteria).
    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
    		 POL6326 1.5 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    POL6326
    Investigational medicinal product code
    POL6326
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/kg POL6326 administered as a 2-hour IV infusion, on treatment Days 1 and 3

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    POL6326 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    POL6326 Placebo administered as a 2-hour IV infusion, on treatment Days 1 and 3

    Number of subjects in period 1
    		POL6326 1.5 mg/kg Placebo
    Started
    60
    60
    Intent to Treat (ITT) Population
    60
    60
    Modified ITT Population
    55
    59
    Per Protocol Population
    48
    56
    Safety Population
    60
    60
    Completed
    31
    28
    Not completed
    29
    32
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Death
    1
    1
         Other
    26
    30
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    POL6326 1.5 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 POL6326 1.5 mg/kg Placebo Total
    Number of subjects
    		 60 60 120
    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)
    		 57.7 ( 10.56 ) 58.5 ( 12.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 8 25
        Male
    		 43 52 95
    LVEF (%)
    Left ventricular ejection fraction (%)
    Units: Subjects
        < Median: 38.0 (%)
    		 29 29 58
        >= Median: 38.0 (%)
    		 31 30 61
        Missing
    		 0 1 1
    LVEDV Index
    Left ventricular end-diastolic volume index
    Units: Subjects
        < Median: 87.5
    		 35 24 59
        >= Median: 87.5
    		 25 34 59
        Missing
    		 0 2 2
    LVESV Index
    Left ventricular end-systolic volume index
    Units: Subjects
        < Median: 53.0
    		 28 25 53
        >= Median: 53.0
    		 32 33 65
        Missing
    		 0 2 2
    Infarct Size
    Units: Subjects
        < Median: 28.0
    		 29 24 53
        >= Median: 28.0
    		 28 31 59
        Missing
    		 3 5 8
    NT-proBNP Level (pg/ml)
    N-terminal pro-B-type natriuretic peptide level
    Units: Subjects
        < Median: 2000.0 (pg/ml)
    		 28 31 59
        >= Median: 2000.0 (pg/ml)
    		 31 28 59
        Missing
    		 1 1 2
    Growth Differentiation Factor-15 (pg/ml)
    Units: Subjects
        < Median: 1319.0 (pg/ml)
    		 25 34 59
        >= Median: 1319.0 (pg/ml)
    		 34 25 59
        Missing
    		 1 1 2
    High-sensitivity Troponin T (pg/ml)
    Units: Subjects
        < Median: 3631.0 (pg/ml)
    		 30 29 59
        >= Median: 3631.0 (pg/ml)
    		 29 30 59
        Missing
    		 1 1 2
    Microvascular Obstruction
    Units: Subjects
        Present
    		 43 45 88
        Not Present
    		 17 14 31
        Missing
    		 0 1 1
    Cardiovascular Examination
    Units: Subjects
        Normal
    		 50 53 103
        Abnormal, NCS
    		 7 7 14
        Abnormal, CS
    		 3 0 3
    Complicated PCI Procedure
    Units: Subjects
        Yes
    		 8 6 14
        No
    		 52 54 106
    PCI Vessel Placement
    Multiple entries could be recorded for a patient
    Units: Subjects
        Left mainstem
    		 1 1 2
        Left anterior descending artery
    		 44 45 89
        Circumflex
    		 6 4 10
        Right coronary artery
    		 6 5 11
        Multiple PCI
    		 3 5 8
    Type of Stent
    Multiple entries could be recorded for a patient
    Units: Subjects
        Bare-metal
    		 19 19 38
        Drug eluting
    		 37 40 77
        Both
    		 4 1 5
    Time from Onset of AMI Symptoms to Reperfusion
    Calculated as [(date and time of reperfusion minus date and time of onset of AMI symptoms) divided by 3600]
    Units: hour
        arithmetic mean (standard deviation)
    		 10.19 ( 14.139 ) 8.69 ( 10.094 ) -
    Time from Onset of AMI Symptoms to Start of First Treatment
    Calculated as [(date and time of start of first treatment minus date and time of onset of AMI symptoms) divided by 86400]
    Units: day
        arithmetic mean (standard deviation)
    		 4.22 ( 0.76 ) 3.95 ( 0.556 ) -
    Time from Reperfusion to Start of First Treatment
    Calculated as [(date and time of start of first treatment minus date and time of reperfusion) divided by 3600]
    Units: hour
        arithmetic mean (standard deviation)
    		 90.4 ( 12.636 ) 85.8 ( 12.577 ) -

    End points

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    End points reporting groups
    Reporting group title
    POL6326 1.5 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    ITT- POL6326 1.5 mg/kg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients were included in the Intent-to-Treat (ITT) population. Patients were analysed according to the randomised treatment.

    Subject analysis set title
    ITT - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients were included in the Intent-to-Treat (ITT) population. Patients were analysed according to the randomised treatment.

    Subject analysis set title
    MITT- POL6326 1.5 mg/kg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomised and treated patients with matching MRI measurements at baseline and at 4 months. Patients were analysed according to the randomised treatment.

    Subject analysis set title
    MITT - Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomised and treated patients with matching MRI measurements at baseline and at 4 months. Patients were analysed according to the randomised treatment.

    Subject analysis set title
    Per-Protocol- POL6326 1.5 mg/kg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the MITT population without important protocol deviations, dosed as per the treatment arm to which they were randomised, and received both treatment infusions.

    Subject analysis set title
    Per-Protocol - Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the MITT population without important protocol deviations, dosed as per the treatment arm to which they were randomised, and received both treatment infusions.

    Subject analysis set title
    Safety Population- POL6326 1.5 mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised patients who received at least one dose of study drug. Patients were analysed according to the treatment they actually received.

    Subject analysis set title
    Safety Population - Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised patients who received at least one dose of study drug. Patients were analysed according to the treatment they actually received.

    Primary: change from baseline of global LVEF

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    End point title
    		 change from baseline of global LVEF
    End point description
    The primary efficacy analysis was the comparison of the change from baseline of global LVEF to the 4-Month visit between POL6326 versus placebo based on the MITT. Hypothesis testing for a potential superiority of POL6326 was performed with a two-sided hypothesis testing.
    End point type
    Primary
    End point timeframe
    At base line (day 2 or 3) and 4 months
    End point values
    		 MITT- POL6326 1.5 mg/kg MITT - Placebo
    Number of subjects analysed
    55
    59
    Units: percent
        arithmetic mean (standard error)
    7.27 ( 1.227 )
    5.56 ( 1.316 )
    Statistical analysis title
    		 LS Mean Differences from Placebo
    Statistical analysis description
    Post-baseline LS means, LS mean differences, 95% CI for differences and p-values were from ANCOVA model with treatment as fixed factor and baseline and gender as covariates.
    Comparison groups
    MITT- POL6326 1.5 mg/kg v MITT - Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.289
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 4.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.606

    Secondary: Change in infarct size

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    End point title
    		 Change in infarct size
    End point description
    End point type
    Secondary
    End point timeframe
    At base line (day 2 or 3) and 4 months
    End point values
    		 MITT- POL6326 1.5 mg/kg MITT - Placebo
    Number of subjects analysed
    50
    51
    Units: percent
        arithmetic mean (standard deviation)
    -7.5 ( 9.43 )
    -7 ( 10.1 )
    Statistical analysis title
    		 LS Mean Differences from Placebo
    Statistical analysis description
    Post-baseline LS means, LS mean differences, 95% CI for differences and p-values were from ANCOVA model with treatment as fixed factor and baseline and gender as covariates.
    Comparison groups
    MITT - Placebo v MITT- POL6326 1.5 mg/kg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.717
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.83
         upper limit
    		 2.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.631

    Secondary: Change in LVEDV index

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    End point title
    		 Change in LVEDV index
    End point description
    End point type
    Secondary
    End point timeframe
    At base line (day 2 or 3) and 4 months
    End point values
    		 MITT- POL6326 1.5 mg/kg MITT - Placebo
    Number of subjects analysed
    55
    58
    Units: percent
        arithmetic mean (standard deviation)
    5.3 ( 21.36 )
    6.4 ( 18.5 )
    Statistical analysis title
    		 LS Mean Differences from Placebo
    Statistical analysis description
    Only patients who had both baseline and post-baseline values are included
    Comparison groups
    MITT- POL6326 1.5 mg/kg v MITT - Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.724
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.29
         upper limit
    		 5.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.547
    Notes
    [1] - Post-baseline LS means, LS mean differences, 95% CI for differences and p-values were from ANCOVA model with treatment as fixed factor and baseline and gender as covariates.

    Secondary: Change in LVESV index

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    End point title
    		 Change in LVESV index
    End point description
    End point type
    Secondary
    End point timeframe
    At base line (day 2 or 3) and 4 months
    End point values
    		 MITT- POL6326 1.5 mg/kg MITT - Placebo
    Number of subjects analysed
    55
    58
    Units: percent
        arithmetic mean (standard deviation)
    -2.3 ( 16.78 )
    0.9 ( 18.29 )
    Statistical analysis title
    		 LS Mean Differences from Placebo
    Statistical analysis description
    Only patients who had both baseline and post-baseline values are included
    Comparison groups
    MITT- POL6326 1.5 mg/kg v MITT - Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.67
         upper limit
    		 3.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.145

    Secondary: Change in regional LV function

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    End point title
    		 Change in regional LV function
    End point description
    Change in regional left ventricular function
    End point type
    Secondary
    End point timeframe
    At base line (day 2 or 3) and 4 months
    End point values
    		 MITT- POL6326 1.5 mg/kg MITT - Placebo
    Number of subjects analysed
    54
    59
    Units: percent
        arithmetic mean (standard deviation)
    0.2 ( 0.8 )
    0.2 ( 0.85 )
    Statistical analysis title
    		 LS Mean Differences from Placebo
    Statistical analysis description
    Only patients who had both baseline and post-baseline values are included
    Comparison groups
    MITT- POL6326 1.5 mg/kg v MITT - Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.872
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed at 6 weeks and 4 months
    End point values
    		 POL6326 1.5 mg/kg Placebo
    Number of subjects analysed
    60
    60
    Units: day
        median (confidence interval 95%)
    350 (350 to 350)
    100 (100 to 100)
    Statistical analysis title
    		 Hazard Ratio relative to Placebo
    Comparison groups
    POL6326 1.5 mg/kg v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.986
    Method
    		 Kaplan-Meier Curves
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.723
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 12.944

    Secondary: Heart failure hospitalisations

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    End point title
    		 Heart failure hospitalisations
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 4 months
    End point values
    		 POL6326 1.5 mg/kg Placebo
    Number of subjects analysed
    60
    60
    Units: day
        median (confidence interval 95%)
    10 (10 to 10)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time of Informed Consent until 4 months after baseline MRI, or ultimate discharge from the study, whichever comes first.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    POL6326 1.5 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 POL6326 1.5 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 60 (26.67%)
    17 / 60 (28.33%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal cancer
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Surgical and medical procedures
    Implantable defibrillator insertion
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    International normalised ratio increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (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: 0%
    Non-serious adverse events
    		 POL6326 1.5 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 60 (40.00%)
    22 / 60 (36.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal neoplasm
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Colorectal cancer
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Intermittent claudication
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Phlebitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Implantable defibrillator insertion
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    3
    2
    Feeling hot
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 60 (1.67%)
         occurrences all number
    2
    1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 60 (5.00%)
         occurrences all number
    2
    3
    Catheter site inflammation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Catheter site pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Device dislocation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Drug ineffective
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Extravasation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Feeling abnormal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Feeling cold
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 60 (3.33%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Rales
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Investigations
    Aspiration bone marrow
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    2
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Colonoscopy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Neutrophil count
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    White blood cell count increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    Arthropod bite
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 60 (3.33%)
         occurrences all number
    4
    2
    Palpitations
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    Intracardiac thrombus
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    2
    Angina pectoris
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Atrioventricular block complete
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    Bradycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Cardiac flutter
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Acute coronary syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Angina unstable
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Arrhythmia
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Atrial fibrillation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Coronary artery stenosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Paresis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Sensory loss
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Hemiparesis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    2
    Haematochezia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Flatulence
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    Angioedema
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Dermal cyst
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Polyuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Bursitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Exostosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    1
    1
    Gout
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    2
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    2
    Hyperlipidaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2014
    Protocol version 4 dated 14 January 2014 (amendment #3), divided the study period in primary (4-Month visit) and extended (12-Month visit) study periods, clarified the eligibility for patients no longer showing ST-segmental elevation or with previous PCI, decreased the eGFR from 60 mL/minute to 40 mL/minute in the inclusion/exclusion criteria, and described changes to the statistical analysis and to the clinical study report. Amendment #3 also changed the time points for some screening procedures, included the urinalysis to the list of assessments, and changed the pharmacokinetic and pharmacodynamic sampling process and time points based on the analysis of PK/PD data from the first 16 randomised patients. Amendment #3 also allowed different strengths for the MRI scanner (both 1.5T and 3T).
    09 Jul 2014
    Protocol version 5 dated 9 May 2014 (amendment # 4) added information specifying the assessments to be performed in the 5 years extended follow-up phase of the study, and described changes to the statistical analysis and to the clinical study report.
    09 Jul 2015
    Following the review of efficacy data analysed according to the planned interim analysis, the IDMC recommended to discontinue the enrollment of any additional patients into the study because of futility (i.e., conditional power (CP) ≤ 10%). The protocol was therefore amended to continue the trial with the 120 patients enrolled up to that point in time until the Month 4 visits were complete. Protocol version 6 dated 8 June 2015 (amendment #5) removed Month 12 as an outpatient visit and replaced it as a follow-up assessment via a telephone contact to ascertain the patients’ health status. In reference to the primary and extended study periods, the 5 years longterm follow-up were also removed. Lastly, the definition of hospitalization was clarified, and the pharmacovigilance provider was changed, and details on additional supportive analysis and endpoints (e.g., high-sensitive troponin T and growth differentiation factor-15 biomarkers) were added. Although protocol version 6 defines study completion as the completion of the Month 4 outpatient visits, 12-Month data collected up to the last Month 4 visit was analysed and included here. Additional exploratory analysis and data collected from the 12-Month telephone contact are intended to be reported in an addendum to the clinical study report.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Apr 2015
    An interim analysis was performed once 50% of the 140 planned patients had completed their 4-month visit and MRI assessment. The IDMC recommended discontinuing further patient recruitment for reasons of futility since the Conditional Power (CP) for success of the trial (defined as the POL6326 arm being superior over the placebo arm for LVEF at 4 months) appeared to be below the lower limit of the pre-defined threshold.
    -

    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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