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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Bendavia™ (MTP-131) on Reperfusion Injury in Patients Treated with Standard Therapy Including Primary PCI and Stenting for ST-segment Elevation Myocardial Infarction

    Summary
    EudraCT number
    		 2011-002824-42
    Trial protocol
    		 HU  
    Global end of trial date
    10 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions
    Summary report(s)
    		 SPIRI-201 summary

    Trial information

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    Trial identification
    Sponsor protocol code
    SPIRI-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01572909
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND : 105942
    Sponsors
    Sponsor organisation name
    Stealth BioTherapeutics Inc.
    Sponsor organisation address
    275 Grove Street, Suite 3-107, Newton, United States, MA 02466
    Public contact
    Jim Carr, Pharm.D. Chief Clinical Development Officer, Stealth BioTherapeutics Inc., 001 6176006888 , jim.carr@stealthbt.com
    Scientific contact
    Jim Carr, Pharm.D. Chief Clinical Development Officer, Stealth BioTherapeutics Inc., 001 6176006888 , jim.carr@stealthbt.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
    23 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to evaluate the impact of Bendavia on limiting the size of infarcted myocardium in patients with first time anterior wall ST-segment elevation myocardial infarction (STEMI) who have undergone successful reperfusion using primary percutaneous coronary intervention (PCI) and stenting.
    Protection of trial subjects
    Written approval of the protocol, the final informed consent document, relevant supporting material and patient recruitment information were obtained from the independent ethics committee (IEC)/institutional review board (IRB) prior to study initiation. The study was conducted in accordance with current applicable regulations, ICH guidelines and local legal requirements. Conduct of the trial complied with the principles that have their origins in the Declaration of Helsinki with emphasis on informed consent and maximizing participant safety.
    Background therapy
    		 Standard-of-care therapy for reduction of reperfusion injury
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 143
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Hungary: 115
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    300
    EEA total number of subjects
    296
    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)
    200
    From 65 to 84 years
    98
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult male and female subjects between the ages of 18 and 85 were recruited at 24 study centers in the United States, Poland, Germany, and Hungary.

    Pre-assignment
    Screening details
    		 Main inclusion criteria: adult males or females aged 18 years or older and less than 85 years old who had undergone PCI plus stenting with the time from onset of symptoms of cardiac ischemia to the time of initial PCI balloon inflation not exceeding 4 hours.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bendavia™
    Investigational medicinal product code
    Other name
    MTP-131, Elamipretide
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bendavia™ was administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Number of subjects in period 1 [1]
    		Active Placebo
    Started
    150
    147
    Completed
    118
    122
    Not completed
    32
    25
         Infarct, comorbidity, Pt refusal of exam
    -
    3
         Physician decision
    1
    1
         Consent withdrawn by subject
    12
    11
         Adverse event, non-fatal
    7
    2
         Death
    3
    1
         Lost to follow-up
    8
    7
         Technical issues
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Three patients lost between screening and baseline.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 150 147 297
    Age categorical
    Age category
    Units: Subjects
        Adults (18-64 years)
    		 96 101 197
        From 65-84 years
    		 53 45 98
        85 years and over
    		 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 45 28 73
        Male
    		 105 119 224

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Primary: Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)

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    End point title
    		 Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)
    End point description
    Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
    End point type
    Primary
    End point timeframe
    The initial 24 and 72 hours post-percutaneous coronary intervention (PCI)
    End point values
    		 Active Placebo
    Number of subjects analysed
    57
    60
    Units: ng*hr/mL
    arithmetic mean (standard deviation)
        72 Hours
    6582.0 ( 3270.6 )
    6738.3 ( 3775.4 )
        24 Hours
    5252.2 ( 2667.9 )
    5471.9 ( 3270.7 )
    Statistical analysis title
    		 Statistical methods
    Statistical analysis description
    Continuous variables were analyzed using analysis of covariance (ANCOVA) or a one-way analysis of variance (ANOVA). Unless otherwise indicated, continuous variables (eg, age, volume of myocardial infarction) were summarized by treatment group using descriptive statistics consisting of number of patients, mean, median, standard deviation or standard error (as appropriate), minimum, and maximum values.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass

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    End point title
    		 Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass
    End point description
    Cardiac infarct size calculated as the ratio of volume of infarcted myocardium to left ventricular mass at Day 30 as measured by MRI.
    End point type
    Secondary
    End point timeframe
    Day 30 + 7
    End point values
    		 Active Placebo
    Number of subjects analysed
    46
    47
    Units: ratio
        arithmetic mean (standard deviation)
    242.3 ( 87.3 )
    225.2 ( 90.70 )
    No statistical analyses for this end point

    Secondary: Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI

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    End point title
    		 Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
    End point description
    TIMI perfusion grade flow at completion of PCI will be categorized as 0,1, or 1.5, 2 or 2.5, 3, and treated as ordinal data, where higher score means better perfusion and lower score means worse perfusion and worse outcome.
    End point type
    Secondary
    End point timeframe
    Initiation to Completion of PCI, no longer than 4 hours
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: participants
        Flow Grade 0
    0
    0
        Flow Grade 1 or 1.5
    0
    0
        Flow Grade 2 or 2.5
    6
    7
        Flow Grade 3
    52
    53
    No statistical analyses for this end point

    Secondary: Corrected TIMI Frame Count

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    End point title
    		 Corrected TIMI Frame Count
    End point description
    Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable.
    End point type
    Secondary
    End point timeframe
    Completion of PCI, no longer than 4 hours
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    59
    Units: corrected frame count
        arithmetic mean (standard deviation)
    79.7 ( 122.8 )
    166.0 ( 286.8 )
    No statistical analyses for this end point

    Secondary: ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution

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    End point title
    		 ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution
    End point description
    ST-Segmented Elevation from pre-PCI to 24 hours post-PCI and Presence of ST-Segmented Resolution by ECG
    End point type
    Secondary
    End point timeframe
    pre-PCI to 24 hours post-PCI
    End point values
    		 Active Placebo
    Number of subjects analysed
    56
    57
    Units: participants
        Complete (>=70% resolution)
    30
    29
        Partial (<70% resolution)
    22
    21
        None (<30% resolution)
    4
    7
    No statistical analyses for this end point

    Secondary: Change in Serum Creatinine From Baseline

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    End point title
    		 Change in Serum Creatinine From Baseline
    End point description
    Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI
    End point type
    Secondary
    End point timeframe
    Day 30 +7
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: umol/L
        arithmetic mean (standard deviation)
    10.55 ( 17.642 )
    88.04 ( 22.462 )
    No statistical analyses for this end point

    Secondary: Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline

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    End point title
    		 Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
    End point description
    Change in eGFR from baseline (prior to study drug administration) to Day 30 +7 post-PCI
    End point type
    Secondary
    End point timeframe
    Day 30 +/- 7
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    50
    Units: mL/min/SSA
        arithmetic mean (standard deviation)
    -12.33 ( 18.873 )
    -8.94 ( 14.242 )
    No statistical analyses for this end point

    Secondary: Cystatin C Change From Baseline

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    End point title
    		 Cystatin C Change From Baseline
    End point description
    Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI
    End point type
    Secondary
    End point timeframe
    Day 30 + 7
    End point values
    		 Active Placebo
    Number of subjects analysed
    53
    49
    Units: mg/L
        arithmetic mean (standard deviation)
    0.19 ( 0.341 )
    0.19 ( 0.226 )
    No statistical analyses for this end point

    Secondary: AUC of Troponin 1 Enzyme

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    End point title
    		 AUC of Troponin 1 Enzyme
    End point description
    Infarct size as calculated by the AUC of Troponin I Enzyme over the initial 24 and 72 hours post-PCI
    End point type
    Secondary
    End point timeframe
    Initial 24 and 72 hours post-PCI
    End point values
    		 Active Placebo
    Number of subjects analysed
    57
    60
    Units: ng*hr/mL
    arithmetic mean (standard deviation)
        72 Hours
    5422.9 ( 3430.9 )
    4647.2 ( 2834.7 )
        24 Hours
    3301.4 ( 2192.9 )
    2850.4 ( 1640.6 )
    No statistical analyses for this end point

    Secondary: Blood Urea Nitrogen (BUN) Change From Baseline

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    End point title
    		 Blood Urea Nitrogen (BUN) Change From Baseline
    End point description
    Blood Urea Nitrogen (BUN) Change from baseline (prior to study drug administration) to Day 30 + 7 post-PCI
    End point type
    Secondary
    End point timeframe
    Baseline to Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    53
    51
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.13 ( 1.603 )
    0.13 ( 2.207 )
    No statistical analyses for this end point

    Secondary: Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI

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    End point title
    		 Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI
    End point description
    Number of Participants with Grade 1 Episode of Contrast-Induced Nephropathy within 48 hours of initial PCI or MRI, based on lab data.
    End point type
    Secondary
    End point timeframe
    Baseline to 48 hours post PCI or MRI
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: participants
        Yes
    17
    11
        No
    41
    49
    No statistical analyses for this end point

    Secondary: Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation

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    End point title
    		 Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation
    End point description
    Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention
    End point type
    Secondary
    End point timeframe
    Baseline up to 1 hour post-PCI
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: participants
        Yes
    2
    3
        No
    56
    57
    No statistical analyses for this end point

    Secondary: Immediate Myocardial Complications: Mechanical Complications

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    End point title
    		 Immediate Myocardial Complications: Mechanical Complications
    End point description
    Number and Percent of Participants with Immediate Myocardial Complications: Mechanical Complications: (Free wall Rupture, Ventricular Septal Defect, Ischemic Mitral Regurgitation)
    End point type
    Secondary
    End point timeframe
    Baseline up to 1 hour post-PCI
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Secondary: Emergency Use of Medications During PCI Procedure

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    End point title
    		 Emergency Use of Medications During PCI Procedure
    End point description
    Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure
    End point type
    Secondary
    End point timeframe
    Initiation to Completion of PCI, no longer than 4 hours
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: Participants
        Yes
    5
    3
        No
    53
    57
    No statistical analyses for this end point

    Secondary: ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30

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    End point title
    		 ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30
    End point description
    NT-proBNP: Change from baseline to Day 30 +7 (Laboratory marker for chronic heart failure (CHF) and systemic inflammation.)
    End point type
    Secondary
    End point timeframe
    Baseline to Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    51
    Units: pg/mL
        arithmetic mean (standard deviation)
    1828.45 ( 3427.408 )
    1582.67 ( 1502.985 )
    No statistical analyses for this end point

    Secondary: High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30

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    End point title
    		 High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30
    End point description
    High Sensitivity C-Reactive Protein (hsCRP): Change from baseline to Day 30 +7 (Laboratory Marker for CHF and Systemic Inflammation)
    End point type
    Secondary
    End point timeframe
    Baseline to Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    51
    45
    Units: mg/L
        arithmetic mean (standard deviation)
    -1.03 ( 7.072 )
    -0.91 ( 7.024 )
    No statistical analyses for this end point

    Secondary: Left Ventricular (LV) Ejection Fraction (%)

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    End point title
    		 Left Ventricular (LV) Ejection Fraction (%)
    End point description
    Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30
    End point type
    Secondary
    End point timeframe
    Day 4 to Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    47
    53
    Units: percentage of blood volume
        arithmetic mean (standard deviation)
    2.1 ( 6.4 )
    2.5 ( 8.3 )
    No statistical analyses for this end point

    Secondary: Difference Between Left Ventricular End Diastolic Volume, Corrected

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    End point title
    		 Difference Between Left Ventricular End Diastolic Volume, Corrected
    End point description
    Difference between Left Ventricular End Diastolic Volume Corrected for Body Surface Area between Day 4 and Day 30
    End point type
    Secondary
    End point timeframe
    Day 4 and Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    45
    52
    Units: mL/m2
        arithmetic mean (standard deviation)
    8.6 ( 12.6 )
    6.2 ( 15.1 )
    No statistical analyses for this end point

    Secondary: Difference Between Left Ventricular End Systolic Volume, Corrected

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    End point title
    		 Difference Between Left Ventricular End Systolic Volume, Corrected
    End point description
    Difference between Left Ventricular End Systolic Volume Corrected for Body Surface Area from Day 4 and Day 30
    End point type
    Secondary
    End point timeframe
    Day 4 and Day 30
    End point values
    		 Active Placebo
    Number of subjects analysed
    45
    52
    Units: mL/m²
        arithmetic mean (standard deviation)
    2.7 ( 8.0 )
    1.5 ( 12.5 )
    No statistical analyses for this end point

    Secondary: Chronic Heart Failure

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    End point title
    		 Chronic Heart Failure
    End point description
    Number and Percentage of Patients with Clinical Events: Chronic Heart Failure beginning within 24 hours after PCI but within the duration of the index hospitalization (Subjects with CHF started within 24 hours after the last balloon deflation while the patient was still in the hospital {including patients who had missing discharge date}).
    End point type
    Secondary
    End point timeframe
    Within 24 hours after PCI
    End point values
    		 Active Placebo
    Number of subjects analysed
    58
    60
    Units: Participants
        Yes
    8
    15
        No
    50
    45
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    21 June 2012 to 22 September 2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as an IV infusion at 60 mL/hr at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel via primary percutaneous coronary intervention and stenting.

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 150 (13.33%)
    14 / 147 (9.52%)
         number of deaths (all causes)
    3
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic Neoplasm
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib Fracture
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternum Fracture
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Procedural Complication
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Femoral Artery Embolism
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 147 (1.36%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 147 (1.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Tamponade
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    4 / 150 (2.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac Thrombus
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemic Cardiomyopathy
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (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
    Sudden cardiac death
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 147 (1.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 147 (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: 2%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 150 (88.67%)
    107 / 147 (72.79%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    4 / 150 (2.67%)
    4 / 147 (2.72%)
         occurrences all number
    4
    4
    Hypertension
         subjects affected / exposed
    11 / 150 (7.33%)
    9 / 147 (6.12%)
         occurrences all number
    11
    9
    Hypotension
         subjects affected / exposed
    5 / 150 (3.33%)
    5 / 147 (3.40%)
         occurrences all number
    5
    5
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    3 / 150 (2.00%)
    1 / 147 (0.68%)
         occurrences all number
    3
    1
    Non-cardiac chest pain
         subjects affected / exposed
    9 / 150 (6.00%)
    5 / 147 (3.40%)
         occurrences all number
    9
    5
    Pyrexia
         subjects affected / exposed
    5 / 150 (3.33%)
    9 / 147 (6.12%)
         occurrences all number
    5
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 150 (4.00%)
    3 / 147 (2.04%)
         occurrences all number
    6
    3
    Dyspnoea
         subjects affected / exposed
    2 / 150 (1.33%)
    5 / 147 (3.40%)
         occurrences all number
    2
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 150 (6.00%)
    14 / 147 (9.52%)
         occurrences all number
    9
    14
    Claustrophobia
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 147 (2.04%)
         occurrences all number
    1
    3
    Insomnia
         subjects affected / exposed
    7 / 150 (4.67%)
    1 / 147 (0.68%)
         occurrences all number
    7
    1
    Investigations
    Blood potassium decreased
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 147 (2.04%)
         occurrences all number
    2
    3
    Ejection fraction decreased
         subjects affected / exposed
    4 / 150 (2.67%)
    1 / 147 (0.68%)
         occurrences all number
    4
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    11 / 150 (7.33%)
    6 / 147 (4.08%)
         occurrences all number
    11
    6
    Atrial fibrillation
         subjects affected / exposed
    6 / 150 (4.00%)
    8 / 147 (5.44%)
         occurrences all number
    6
    8
    Bradycardia
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 147 (2.04%)
         occurrences all number
    0
    3
    Cardiac Failure
         subjects affected / exposed
    28 / 150 (18.67%)
    29 / 147 (19.73%)
         occurrences all number
    28
    29
    Cardiac Failure Congestive
         subjects affected / exposed
    5 / 150 (3.33%)
    5 / 147 (3.40%)
         occurrences all number
    5
    5
    Coronary Artery Disease
         subjects affected / exposed
    5 / 150 (3.33%)
    5 / 147 (3.40%)
         occurrences all number
    5
    5
    Coronary artery stenosis
         subjects affected / exposed
    3 / 150 (2.00%)
    4 / 147 (2.72%)
         occurrences all number
    3
    4
    Intracardiac thrombus
         subjects affected / exposed
    9 / 150 (6.00%)
    10 / 147 (6.80%)
         occurrences all number
    9
    10
    Mitral Valve Incompetence
         subjects affected / exposed
    3 / 150 (2.00%)
    1 / 147 (0.68%)
         occurrences all number
    3
    1
    Pericardial effusion
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 147 (2.04%)
         occurrences all number
    0
    3
    Ventricular Tachycardia
         subjects affected / exposed
    4 / 150 (2.67%)
    4 / 147 (2.72%)
         occurrences all number
    4
    4
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 150 (2.67%)
    1 / 147 (0.68%)
         occurrences all number
    4
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 147 (1.36%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    6 / 150 (4.00%)
    2 / 147 (1.36%)
         occurrences all number
    6
    2
    Hypotonia
         subjects affected / exposed
    3 / 150 (2.00%)
    3 / 147 (2.04%)
         occurrences all number
    3
    3
    Syncope
         subjects affected / exposed
    3 / 150 (2.00%)
    0 / 147 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 150 (4.00%)
    6 / 147 (4.08%)
         occurrences all number
    6
    6
    Thrombocytopenia
         subjects affected / exposed
    3 / 150 (2.00%)
    0 / 147 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 150 (0.67%)
    4 / 147 (2.72%)
         occurrences all number
    1
    4
    Diarrhoea
         subjects affected / exposed
    4 / 150 (2.67%)
    7 / 147 (4.76%)
         occurrences all number
    4
    7
    Nausea
         subjects affected / exposed
    9 / 150 (6.00%)
    7 / 147 (4.76%)
         occurrences all number
    9
    7
    Vomiting
         subjects affected / exposed
    8 / 150 (5.33%)
    7 / 147 (4.76%)
         occurrences all number
    8
    7
    Renal and urinary disorders
    Renal Failure Chronic
         subjects affected / exposed
    1 / 150 (0.67%)
    3 / 147 (2.04%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 150 (3.33%)
    7 / 147 (4.76%)
         occurrences all number
    5
    7
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 150 (2.00%)
    4 / 147 (2.72%)
         occurrences all number
    3
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 147 (2.04%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    12 / 150 (8.00%)
    7 / 147 (4.76%)
         occurrences all number
    12
    7
    Glucose Tolerance Impairment
         subjects affected / exposed
    5 / 150 (3.33%)
    6 / 147 (4.08%)
         occurrences all number
    5
    6
    Hypercholesterolaemia
         subjects affected / exposed
    30 / 150 (20.00%)
    19 / 147 (12.93%)
         occurrences all number
    30
    19
    Hyperlipidaemia
         subjects affected / exposed
    6 / 150 (4.00%)
    9 / 147 (6.12%)
         occurrences all number
    6
    9
    Hypokalaemia
         subjects affected / exposed
    27 / 150 (18.00%)
    27 / 147 (18.37%)
         occurrences all number
    27
    27
    Hyponatraemia
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 147 (1.36%)
         occurrences all number
    3
    2
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 150 (2.00%)
    1 / 147 (0.68%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2012
    • Inclusion criteria for menopause was clarified as >12 months of no menses. • Maximal infusion time for investigational product was adjusted to <4 hours. • Primary Analysis Population must have received ≥10 minutes pre- and ≥45 minutes post-PCI infusion of study drug. • Added STAT local serum sodium and serum creatinine, drawn prior to the PCI and if the sodium was <135 mEq/L or the eGFR was <50 mL/min, the study drug infusion was stopped and repeat values obtained.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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