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    Clinical Trial Results:
    A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients with ST-Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary Intervention

    Summary
    EudraCT number
    		 2013-002312-27
    Trial protocol
    		 DK  
    Global end of trial date
    04 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    13-031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01977755
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand Pharma A/S
    Sponsor organisation address
    Sydmarken 11, Soeborg, Denmark, 2860
    Public contact
    Clinical Operations, Zealand Pharma A/S, 45 88 77 36 00, clinicaltrials@zealandpharma.com
    Scientific contact
    Clinical Operations, Zealand Pharma A/S, +45 8877 3600, clinicaltrials@zealandpharma.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
    01 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the efficacy of two dose levels of Danegaptide to placebo when added to the standard treatment of STEMI in patients with single vessel disease having TIMI flow 0 or 1 prior to PCI conducted within 6 hours of symptoms debut.
    Protection of trial subjects
    The trial was conducted in accordance of the World Medical Association Declaration of Helsinki, current guidelines for GCP and local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 2013
    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
    Denmark: 585
    Worldwide total number of subjects
    585
    EEA total number of subjects
    585
    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)
    363
    From 65 to 84 years
    217
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at one (1) site in Denmark.

    Pre-assignment
    Screening details
    		 A total of 1744 patients were screened of which 585 patients were randomized.

    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
    Blinding implementation details
    Investigator, all site research personnel, sponsor and CRO staff were blinded to trial treatment until the database was locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High dose danegaptide
    Arm description
    		 Subjects in this arm received 7.5 mg bolus injection followed by 22.5 mg infused over 6 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danegaptide 2.0 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Subjects received 2 bolus injections of danegaptide, followed by infusion of danegaptide over 6 hours. The dose given depended on which arm the subjects were randomised to.

    Arm title
    		 Low dose danegaptide
    Arm description
    		 Subjects in this arm received danegaptide as 2.5 mg bolus injection followed by 7.5 mg infused over 6 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danegaptide 2.0 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Subjects received 2 bolus injections of danegaptide, followed by infusion of danegaptide over 6 hours. The dose given depended on which arm the subjects were randomised to.

    Arm title
    		 Placebo
    Arm description
    		 Subjects in this arm received placebo matching the treatment given in the experimental arms.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Subjects received 2 bolus injections of placebo, followed by infusion of placebo over 6 hours.

    Number of subjects in period 1
    		High dose danegaptide Low dose danegaptide Placebo
    Started
    184
    206
    195
    Completed
    167
    183
    181
    Not completed
    17
    23
    14
         Consent withdrawn by subject
    2
    6
    2
         Adverse event, non-fatal
    -
    1
    -
         Death
    3
    3
    4
         Other
    8
    6
    4
         Lost to follow-up
    4
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    High dose danegaptide
    Reporting group description
    		 Subjects in this arm received 7.5 mg bolus injection followed by 22.5 mg infused over 6 hours

    Reporting group title
    Low dose danegaptide
    Reporting group description
    		 Subjects in this arm received danegaptide as 2.5 mg bolus injection followed by 7.5 mg infused over 6 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm received placebo matching the treatment given in the experimental arms.

    Reporting group values
    		 High dose danegaptide Low dose danegaptide Placebo Total
    Number of subjects
    		 184 206 195 585
    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)
    		 60.5 ± 11.6 60.0 ± 11.1 61.0 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 39 46 49 134
        Male
    		 145 160 146 451
    Killip class
    Subject with heart failure based on Killip classification of the subject. Any symptoms consistent with Killip class II-IV were considered heart failure and were documented in the patient file and trial eCRF.
    Units: Subjects
        Killip class I
    		 178 198 192 568
        Killip class II
    		 6 6 2 14
        Killip class III
    		 0 1 1 2
        Not recorded
    		 0 1 0 1
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.3 ± 3.8 26.9 ± 4.1 27.4 ± 4.3 -
    Subject analysis sets

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was regarded as the practical implementation of the Intention-to-treat (ITT) set and comprised all ITT patients who received 1) at least one dose of trial drug and 2) had at least one valid post-baseline efficacy endpoint. The IIT, FAS and Safety Analysis set (SAS) were identical.

    Subject analysis set title
    Per protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set was defined as the subset of the FASimg including patients with an evaluable cardiac Magnetic Resonance Imaging (cMRI) scan at both Day 2 and Day 90, an available area at risk (AAR) for calculation of the primary endpoint and who did not have any critical protocol deviation.

    Subject analysis sets values
    		 Full analysis set (FAS) Per protocol (PP)
    Number of subjects
    585
    169
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.5 ± 11.2
    56.8 ± 9.7
    Gender categorical
    Units: Subjects
        Female
    134
    31
        Male
    451
    138
    Killip class
    Subject with heart failure based on Killip classification of the subject. Any symptoms consistent with Killip class II-IV were considered heart failure and were documented in the patient file and trial eCRF.
    Units: Subjects
        Killip class I
    568
    168
        Killip class II
    14
    1
        Killip class III
    2
    0
        Not recorded
    1
    0
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    27.2 ± 4.1
    27.4 ± 4.4

    End points

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    End points reporting groups
    Reporting group title
    High dose danegaptide
    Reporting group description
    		 Subjects in this arm received 7.5 mg bolus injection followed by 22.5 mg infused over 6 hours

    Reporting group title
    Low dose danegaptide
    Reporting group description
    		 Subjects in this arm received danegaptide as 2.5 mg bolus injection followed by 7.5 mg infused over 6 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm received placebo matching the treatment given in the experimental arms.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was regarded as the practical implementation of the Intention-to-treat (ITT) set and comprised all ITT patients who received 1) at least one dose of trial drug and 2) had at least one valid post-baseline efficacy endpoint. The IIT, FAS and Safety Analysis set (SAS) were identical.

    Subject analysis set title
    Per protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP set was defined as the subset of the FASimg including patients with an evaluable cardiac Magnetic Resonance Imaging (cMRI) scan at both Day 2 and Day 90, an available area at risk (AAR) for calculation of the primary endpoint and who did not have any critical protocol deviation.

    Primary: Myocardial Salvage Index (MSI)

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    End point title
    		 Myocardial Salvage Index (MSI)
    End point description
    The difference between myocardial volume at risk in the acute phase and final infarct size at Day 90 in relation to myocardial volume at risk in the acute phase
    End point type
    Primary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Myocardial Salvage Index (MSI)
        arithmetic mean (standard deviation)
    63.9 ± 14.9
    65.6 ± 15.6
    66.7 ± 11.7
    65.4 ± 14.2
    Statistical analysis title
    		 Primary efficacy analysis - placebo vs Dane. high
    Statistical analysis description
    Primary efficacy analysis of myocardial salvage index (per-protocol analysis set). The primary efficacy endpoint as analysed using an analysis of covariance model with treatment group as independent variable and relative infarct size at baseline, age, gender and TIMI level at Day 2 as covariates.
    Comparison groups
    Placebo v High dose danegaptide
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 0.8
    Statistical analysis title
    		 Primary efficacy analysis - placebo vs Dane. low
    Statistical analysis description
    Primary efficacy analysis of myocardial salvage index (per-protocol analysis set). The primary efficacy endpoint as analysed using an analysis of covariance model with treatment group as independent variable and relative infarct size at baseline, age, gender and TIMI level at Day 2 as covariates.
    Comparison groups
    Low dose danegaptide v Placebo
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.23
         upper limit
    		 2.88

    Secondary: Relative infarct size Day 90

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    End point title
    		 Relative infarct size Day 90
    End point description
    Relative infarct size [infarct size/left ventricle (LV) size (g/g)] × 100), as assessed by LGE cMRI, at Day 90.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: percent
        arithmetic mean (standard deviation)
    14.0 ± 7.1
    13.7 ± 6.7
    15.4 ± 7.7
    14.3 ± 7.2
    No statistical analyses for this end point

    Secondary: Relative infarct size Day 2

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    End point title
    		 Relative infarct size Day 2
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    55
    58
    51
    164
    Units: percent
        arithmetic mean (standard deviation)
    21.7 ± 10.6
    21.2 ± 9.7
    24.2 ± 13.0
    22.3 ± 11.1
    No statistical analyses for this end point

    Secondary: Change in relative infarct size

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    End point title
    		 Change in relative infarct size
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 2 (baseline) to Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    55
    58
    51
    164
    Units: percent
        arithmetic mean (standard deviation)
    -7.6 ± 6.6
    -7.3 ± 5.5
    -8.7 ± 8.2
    -7.8 ± 6.8
    No statistical analyses for this end point

    Secondary: Absolute infarct size Day 90

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    End point title
    		 Absolute infarct size Day 90
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: gram(s)
        arithmetic mean (standard deviation)
    19.6 ± 11.4
    18.6 ± 9.6
    21.4 ± 15.0
    19.8 ± 12.0
    No statistical analyses for this end point

    Secondary: Change in absolute infarct size

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    End point title
    		 Change in absolute infarct size
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 2 (baseline) to Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    55
    58
    51
    164
    Units: gram(s)
        arithmetic mean (standard deviation)
    -14 ± 12.1
    -13 ± 9.8
    -18 ± 17.9
    -15 ± 13.6
    No statistical analyses for this end point

    Secondary: Left ventricular ejection fraction (LVEF) Day 2

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    End point title
    		 Left ventricular ejection fraction (LVEF) Day 2
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    58
    52
    167
    Units: percent
        arithmetic mean (standard deviation)
    45.4 ± 8.9
    47.0 ± 8.7
    45.3 ± 9.7
    45.9 ± 9.1
    No statistical analyses for this end point

    Secondary: Left ventricular ejection fraction (LVEF) Day 90

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    End point title
    		 Left ventricular ejection fraction (LVEF) Day 90
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: percent
        arithmetic mean (standard deviation)
    53.9 ± 9.5
    52.7 ± 10.3
    52.1 ± 10.9
    52.9 ± 10.2
    No statistical analyses for this end point

    Secondary: Change in left ventricular ejection fraction (LVEF)

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    End point title
    		 Change in left ventricular ejection fraction (LVEF)
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 2 (baseline) to Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    58
    52
    167
    Units: percent
        arithmetic mean (standard deviation)
    8.6 ± 8.3
    5.7 ± 8.0
    6.8 ± 9.1
    7.0 ± 8.5
    No statistical analyses for this end point

    Secondary: Change in left ventricular end-systolic volume (LV-ESV) as measured by cMRI

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    End point title
    		 Change in left ventricular end-systolic volume (LV-ESV) as measured by cMRI
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 2 (baseline) to Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    58
    52
    167
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    -9.3 ± 20.5
    -3.5 ± 25.4
    -4.4 ± 30.3
    -5.8 ± 25.6
    No statistical analyses for this end point

    Secondary: Change in left ventricular end-diastolic volume (LV-EDV) as measured by cMRI

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    End point title
    		 Change in left ventricular end-diastolic volume (LV-EDV) as measured by cMRI
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 2 (baseline) to Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    58
    52
    167
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    9.8 ± 29.1
    10.8 ± 26.4
    14.2 ± 29.8
    11.5 ± 28.3
    No statistical analyses for this end point

    Secondary: Relative volume with microvascular obstruction (MVO) as assessed by cMRI

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    End point title
    		 Relative volume with microvascular obstruction (MVO) as assessed by cMRI
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    55
    58
    51
    164
    Units: percent
        arithmetic mean (standard deviation)
    12.6 ± 12.3
    10.9 ± 12.8
    11.0 ± 10.8
    11.5 ± 12.0
    No statistical analyses for this end point

    Secondary: 90-day clinical outcome/MACE [cardiac death, new or worsening heart failure (during the initial hospitalization) and re-hospitalization due to heart failure]

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    End point title
    		 90-day clinical outcome/MACE [cardiac death, new or worsening heart failure (during the initial hospitalization) and re-hospitalization due to heart failure]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    184
    206
    195
    585
    Units: Patients
        Cardiac death
    3
    2
    5
    10
        Myocardial re-infarction
    1
    2
    2
    5
        New onset or worsening heart failure
    10
    8
    7
    25
        Re-admission during the 90 day FU
    3
    2
    1
    6
        Stent thrombosis
    1
    2
    2
    5
        Stroke
    1
    3
    2
    6
    No statistical analyses for this end point

    Secondary: Significant arrhythmias - Severe alerts during Telemetry Asystoli/Marked QRS pause(>4sec)

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    End point title
    		 Significant arrhythmias - Severe alerts during Telemetry Asystoli/Marked QRS pause(>4sec)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    Units: Patients
        Yes
    0
    2
    2
    4
        No
    56
    48
    50
    154
    No statistical analyses for this end point

    Secondary: Significant arrhythmias - Extreme Tachycardia. HF > 180

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    End point title
    		 Significant arrhythmias - Extreme Tachycardia. HF > 180
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Patients
        Yes
    0
    2
    0
    2
        No
    56
    50
    50
    156
    No statistical analyses for this end point

    Secondary: Significant arrhythmias - Extreme bradycardia. HF < 30

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    End point title
    		 Significant arrhythmias - Extreme bradycardia. HF < 30
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Patients
        Yes
    2
    2
    2
    6
        No
    54
    50
    48
    152
    No statistical analyses for this end point

    Secondary: Significant arrhythmias - Ventricular Tachycard.VES>=5, frq. > 100

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    End point title
    		 Significant arrhythmias - Ventricular Tachycard.VES>=5, frq. > 100
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Patients
        Yes
    54
    48
    46
    148
        No
    2
    6
    6
    14
    No statistical analyses for this end point

    Secondary: Significant arrhythmias - Ventricular fibrillation. If VF >= 4 sec

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    End point title
    		 Significant arrhythmias - Ventricular fibrillation. If VF >= 4 sec
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Patients
        Yes
    2
    2
    4
    8
        No
    54
    50
    48
    152
    No statistical analyses for this end point

    Secondary: Degree of ST-segment resolution 60 minutes after PCI

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    End point title
    		 Degree of ST-segment resolution 60 minutes after PCI
    End point description
    End point type
    Secondary
    End point timeframe
    Measured 60 minutes post-PCI procedure on Day 0
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    135
    152
    151
    438
    Units: Patients
        <1 mm
    78
    87
    84
    249
        1-2 mm
    17
    27
    32
    76
        ≥2 mm
    40
    38
    35
    113
    No statistical analyses for this end point

    Secondary: Patients with ≥70% ST-segment resolution 60 minutes after PCI

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    End point title
    		 Patients with ≥70% ST-segment resolution 60 minutes after PCI
    End point description
    End point type
    Secondary
    End point timeframe
    Measured 60 minutes post-PCI procedure on Day 0
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    136
    153
    151
    440
    Units: Patients
        No
    47
    49
    58
    154
        Yes
    89
    104
    93
    286
    No statistical analyses for this end point

    Secondary: AUC,0-48 Creatine Kinase-MB

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    End point title
    		 AUC,0-48 Creatine Kinase-MB
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from Day 1 after PCI until discharge
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    159
    179
    169
    507
    Units: μg*h/L
        arithmetic mean (standard deviation)
    3839 ± 2749
    3468 ± 2499
    3246 ± 2621
    3508 ± 2625
    No statistical analyses for this end point

    Secondary: Cmax Creatine Kinase-MB

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    End point title
    		 Cmax Creatine Kinase-MB
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from Day 1 after PCI until discharge
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    168
    190
    181
    539
    Units: μg/L
        arithmetic mean (standard deviation)
    207 ± 159
    191 ± 144
    179 ± 148
    192 ± 150
    No statistical analyses for this end point

    Secondary: AUC,0-48 Troponin-T

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    End point title
    		 AUC,0-48 Troponin-T
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from Day 1 after PCI until discharge
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    154
    160
    164
    478
    Units: ng*h/L
        arithmetic mean (standard deviation)
    167568 ± 156757
    175173 ± 161646
    164000 ± 170992
    168889 ± 163110
    No statistical analyses for this end point

    Secondary: Cmax Troponin-T

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    End point title
    		 Cmax Troponin-T
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from Day 1 after PCI until discharge
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    163
    181
    179
    523
    Units: ng/L
        arithmetic mean (standard deviation)
    5574 ± 5749
    5576 ± 5774
    5491 ± 7372
    5546 ± 6347
    No statistical analyses for this end point

    Secondary: TIMI-flow as assessed immediately after the PCI procedure

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    End point title
    		 TIMI-flow as assessed immediately after the PCI procedure
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed immediately after PCI procedure on Day 0
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Per protocol (PP)
    Number of subjects analysed
    57
    60
    52
    169
    Units: Patients
        TIMI flow 2
    1
    0
    2
    3
        TIMI flow 3
    56
    60
    50
    166
    No statistical analyses for this end point

    Secondary: SF36 - Physical Component Summary Score (PCS)

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    End point title
    		 SF36 - Physical Component Summary Score (PCS)
    End point description
    Scale 0-100, where a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    155
    161
    164
    480
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    40.2 ± 4.6
    41.1 ± 4.2
    40.8 ± 4.3
    40.7 ± 4.4
    No statistical analyses for this end point

    Secondary: SF36 - Mental Component Summary Score (MCS)

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    End point title
    		 SF36 - Mental Component Summary Score (MCS)
    End point description
    Scale 0-100, where a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    156
    163
    166
    485
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    57.0 ± 13.1
    56.5 ± 11.6
    56.6 ± 12.0
    56.7 ± 12.2
    No statistical analyses for this end point

    Secondary: EQ-5D-5L VAS Score

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    End point title
    		 EQ-5D-5L VAS Score
    End point description
    Scores on a vertical visual analogue scale (VAS) that takes values between 100 (best imaginable health) and 0 (worst imaginable health).
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    156
    161
    167
    484
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    76.3 ± 19.0
    78.3 ± 15.7
    78.0 ± 17.7
    77.6 ± 17.5
    No statistical analyses for this end point

    Secondary: Plasma concentration of Danegaptide at the end of the PCI procedure

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    End point title
    		 Plasma concentration of Danegaptide at the end of the PCI procedure
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 after PCS procedure
    End point values
    		 High dose danegaptide Low dose danegaptide Placebo Full analysis set (FAS)
    Number of subjects analysed
    183
    205
    192
    580
    Units: ng/mL
        arithmetic mean (standard deviation)
    451 ± 369
    141 ± 48.4
    1.0 ± 0.0
    192 ± 279
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 until Day 90
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    High dose danegaptide
    Reporting group description
    		 Subjects in this arm received 7.5 mg bolus injection followed by 22.5 mg infused over 6 hours

    Reporting group title
    Low dose danegaptide
    Reporting group description
    		 Subjects in this arm received danegaptide as 2.5 mg bolus injection followed by 7.5 mg infused over 6 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm received placebo matching the treatment given in the experimental arms.

    Serious adverse events
    		 High dose danegaptide Low dose danegaptide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 184 (16.85%)
    43 / 206 (20.87%)
    42 / 195 (21.54%)
         number of deaths (all causes)
    3
    3
    4
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma stage II
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    7 / 184 (3.80%)
    3 / 206 (1.46%)
    6 / 195 (3.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 184 (0.54%)
    3 / 206 (1.46%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    Malaise
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 206 (0.97%)
    2 / 195 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    2 / 184 (1.09%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site thrombosis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 184 (1.09%)
    5 / 206 (2.43%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    2 / 195 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 184 (0.54%)
    3 / 206 (1.46%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 184 (1.09%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 184 (0.54%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    4 / 184 (2.17%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 206 (0.97%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 184 (0.00%)
    3 / 206 (1.46%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    2 / 195 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 184 (0.54%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 206 (0.97%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    2 / 195 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 184 (0.54%)
    2 / 206 (0.97%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 206 (0.97%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 206 (0.49%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 184 (0.00%)
    2 / 206 (0.97%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 184 (1.09%)
    2 / 206 (0.97%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 206 (0.00%)
    1 / 195 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 206 (0.00%)
    0 / 195 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 High dose danegaptide Low dose danegaptide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 184 (75.54%)
    154 / 206 (74.76%)
    136 / 195 (69.74%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    21 / 184 (11.41%)
    23 / 206 (11.17%)
    21 / 195 (10.77%)
         occurrences all number
    22
    25
    21
    Blood potassium decreased
         subjects affected / exposed
    10 / 184 (5.43%)
    10 / 206 (4.85%)
    14 / 195 (7.18%)
         occurrences all number
    10
    10
    14
    C-reactive protein increased
         subjects affected / exposed
    16 / 184 (8.70%)
    8 / 206 (3.88%)
    9 / 195 (4.62%)
         occurrences all number
    16
    8
    9
    Hemoglobin decreased
         subjects affected / exposed
    11 / 184 (5.98%)
    13 / 206 (6.31%)
    8 / 195 (4.10%)
         occurrences all number
    11
    13
    8
    White blood cell count increased
         subjects affected / exposed
    12 / 184 (6.52%)
    7 / 206 (3.40%)
    12 / 195 (6.15%)
         occurrences all number
    12
    7
    12
    ASAT increased
         subjects affected / exposed
    9 / 184 (4.89%)
    9 / 206 (4.37%)
    10 / 195 (5.13%)
         occurrences all number
    9
    9
    10
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    11 / 184 (5.98%)
    13 / 206 (6.31%)
    22 / 195 (11.28%)
         occurrences all number
    11
    13
    22
    Vascular disorders
    Hypotension
         subjects affected / exposed
    29 / 184 (15.76%)
    32 / 206 (15.53%)
    26 / 195 (13.33%)
         occurrences all number
    29
    33
    26
    Hypertension
         subjects affected / exposed
    8 / 184 (4.35%)
    11 / 206 (5.34%)
    12 / 195 (6.15%)
         occurrences all number
    8
    11
    13
    Hematoma
         subjects affected / exposed
    8 / 184 (4.35%)
    14 / 206 (6.80%)
    9 / 195 (4.62%)
         occurrences all number
    8
    15
    9
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    15 / 184 (8.15%)
    9 / 206 (4.37%)
    15 / 195 (7.69%)
         occurrences all number
    16
    9
    15
    Ventricular tachycardia
         subjects affected / exposed
    6 / 184 (3.26%)
    12 / 206 (5.83%)
    10 / 195 (5.13%)
         occurrences all number
    6
    12
    10
    Bradycardia
         subjects affected / exposed
    4 / 184 (2.17%)
    14 / 206 (6.80%)
    8 / 195 (4.10%)
         occurrences all number
    4
    14
    8
    Angina pectoris
         subjects affected / exposed
    4 / 184 (2.17%)
    12 / 206 (5.83%)
    2 / 195 (1.03%)
         occurrences all number
    5
    12
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    15 / 184 (8.15%)
    23 / 206 (11.17%)
    22 / 195 (11.28%)
         occurrences all number
    16
    23
    23
    Headache
         subjects affected / exposed
    19 / 184 (10.33%)
    13 / 206 (6.31%)
    10 / 195 (5.13%)
         occurrences all number
    21
    13
    11
    Insomnia
         subjects affected / exposed
    34 / 184 (18.48%)
    31 / 206 (15.05%)
    34 / 195 (17.44%)
         occurrences all number
    34
    31
    34
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    22 / 184 (11.96%)
    27 / 206 (13.11%)
    29 / 195 (14.87%)
         occurrences all number
    25
    30
    33
    Fatigue
         subjects affected / exposed
    37 / 184 (20.11%)
    30 / 206 (14.56%)
    32 / 195 (16.41%)
         occurrences all number
    37
    31
    33
    Chest discomfort
         subjects affected / exposed
    18 / 184 (9.78%)
    26 / 206 (12.62%)
    20 / 195 (10.26%)
         occurrences all number
    23
    27
    24
    Oedema peripheral
         subjects affected / exposed
    10 / 184 (5.43%)
    11 / 206 (5.34%)
    11 / 195 (5.64%)
         occurrences all number
    11
    11
    11
    Application site haematoma
         subjects affected / exposed
    6 / 184 (3.26%)
    13 / 206 (6.31%)
    5 / 195 (2.56%)
         occurrences all number
    7
    14
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    19 / 184 (10.33%)
    25 / 206 (12.14%)
    21 / 195 (10.77%)
         occurrences all number
    20
    27
    21
    Nausea
         subjects affected / exposed
    15 / 184 (8.15%)
    20 / 206 (9.71%)
    16 / 195 (8.21%)
         occurrences all number
    16
    20
    16
    Diarrhea
         subjects affected / exposed
    5 / 184 (2.72%)
    6 / 206 (2.91%)
    13 / 195 (6.67%)
         occurrences all number
    5
    6
    14
    Vomiting
         subjects affected / exposed
    14 / 184 (7.61%)
    5 / 206 (2.43%)
    6 / 195 (3.08%)
         occurrences all number
    14
    5
    6
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    42 / 184 (22.83%)
    45 / 206 (21.84%)
    38 / 195 (19.49%)
         occurrences all number
    50
    49
    41
    Cough
         subjects affected / exposed
    8 / 184 (4.35%)
    8 / 206 (3.88%)
    12 / 195 (6.15%)
         occurrences all number
    8
    8
    12
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    11 / 184 (5.98%)
    4 / 206 (1.94%)
    4 / 195 (2.05%)
         occurrences all number
    12
    4
    4
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    11 / 184 (5.98%)
    11 / 206 (5.34%)
    10 / 195 (5.13%)
         occurrences all number
    11
    11
    10
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 184 (6.52%)
    11 / 206 (5.34%)
    14 / 195 (7.18%)
         occurrences all number
    12
    11
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2013
    Amendment 01: The reason for the amendment was to add assessments of health related quality of life and a urinary biomarker for oxidative stress.
    23 Jan 2014
    Amendment 02: Adjustments made to the protocol according to the initial experiences made during the trial and to better match the normal clinical procedures at the trial site.
    05 Jan 2015
    Amendment 03: Protocol amended to specify that patients who were not treated with PCI could be terminated from trial participation after 2-3 weeks of follow-up.
    02 Jul 2015
    Amendment 04: Number of patients estimated to be required to reach the needed sample size was reduced.
    03 Dec 2015
    Amendment 05: Addition of a supportive exploratory analysis.

    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/29602883
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