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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention

    Summary
    EudraCT number
    		 2020-000238-16
    Trial protocol
    		 NL   SE  
    Global end of trial date
    31 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2023
    First version publication date
    03 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C5071002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04848220
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 APD791-202: Other study ID
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Blvd, New York, United States, NY 10018
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquires@pfizer.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
    19 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effect of temanogrel on microvascular obstruction (MVO) following percutaneous coronary intervention (PCI).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2021
    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
    Australia: 12
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    27
    EEA total number of subjects
    10
    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)
    13
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in two stages: Stage A (an ascending single dose study consisting of 2 cohorts of 20 and 40 milligram [mg] doses of temanogrel or placebo) and Stage B: parallel group study (consisting of 3 treatment groups of temanogrel 20 mg, temanogrel 40 mg and placebo). The study was terminated early due to business decision.

    Pre-assignment
    Screening details
    		 A total of 29 subjects were enrolled and randomized in the study of which only 27 subjects received the study treatment and were included in the safety population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Temanogrel 20 mg
    Arm description
    		 Subjects received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the subjects underwent percutaneous coronary intervention (PCI). Subjects had a follow-up phone call 7 days after administration of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temanogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg single dose

    Arm title
    		 Temanogrel 40 mg
    Arm description
    		 Subjects received a single IV dose of temanogrel 40 mg on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temanogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg single dose

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single IV dose of placebo on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.
    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
    Single dose

    Number of subjects in period 1
    		Temanogrel 20 mg Temanogrel 40 mg Placebo
    Started
    10
    8
    9
    Completed
    10
    8
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Temanogrel 20 mg
    Reporting group description
    		 Subjects received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the subjects underwent percutaneous coronary intervention (PCI). Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Temanogrel 40 mg
    Reporting group description
    		 Subjects received a single IV dose of temanogrel 40 mg on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single IV dose of placebo on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo Total
    Number of subjects
    		 10 8 9 27
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 4 4 5 13
        From 65-84 years
    		 6 4 4 14
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.9 ( 7.81 ) 64.5 ( 3.27 ) 63.3 ( 9.63 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 0 3 4
        Male
    		 9 8 6 23
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 7 7 9 23
        More than one race
    		 0 0 0 0
        Unknown
    		 1 1 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 1
        Not Hispanic or Latino
    		 10 7 9 26
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Temanogrel 20 mg
    Reporting group description
    		 Subjects received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the subjects underwent percutaneous coronary intervention (PCI). Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Temanogrel 40 mg
    Reporting group description
    		 Subjects received a single IV dose of temanogrel 40 mg on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single IV dose of placebo on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Primary: Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)

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    End point title
    		 Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI) [1]
    End point description
    IMR was defined as the mean distal pressure at maximum hyperemia multiplied by the mean hyperemic transit time. IMRcorr (IMR corrected for the influence from collateral supply) was calculated using the following equation, to account for the presence of significant epicardial stenosis without the need for balloon dilation to measure the coronary wedge pressure (Pw), IMRcorr=mean aortic pressure at maximum hyperemia (Pa)* mean transit time at maximal hyperemia (Tmn)*[1.34*mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32]. Full analysis set(FAS) included all randomised subjects, irrespective of whether they received any study treatment. Here, ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Primary
    End point timeframe
    From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to early study termination and low sample size, statistical analyses were not performed.
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    9
    8
    9
    Units: Millimeter of mercury*seconds
        arithmetic mean (standard deviation)
    -8.1783 ( 15.35531 )
    0.0691 ( 13.27702 )
    -1.8907 ( 18.82659 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)

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    End point title
    		 Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)
    End point description
    The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time. FAS included all randomised subjects, irrespective of whether they received any study treatment. Here, ‘Number of Subjects Analyzed’ signifies subjects evaluable for this endpoint. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    9
    8
    9
    Units: Ratio
        arithmetic mean (standard deviation)
    1.2744 ( 0.89307 )
    1.0238 ( 2.97729 )
    1.3787 ( 1.40440 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)

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    End point title
    		 Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)
    End point description
    The FFR was calculated from the ratio of distal to proximal mean pressures at maximal hyperemia (FFR=[distal coronary pressure/aortic pressure at maximum hyperemia]). FAS included all randomised subjects, irrespective of whether they received any study treatment. Here, ‘Number of Subjects Analyzed’ signifies subjects evaluable for this endpoint. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    9
    8
    9
    Units: Ratio
        arithmetic mean (standard deviation)
    0.1346 ( 0.19620 )
    0.2494 ( 0.20758 )
    0.3123 ( 0.16562 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)

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    End point title
    		 Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)
    End point description
    The cTFC is a quantitative index of coronary flow and was calculated based upon the number of cine-frames that the intracoronary dye required to reach distal coronary landmarks. Safety set included all subjects in the FAS who received any study treatment. Here, ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    9
    7
    8
    Units: Frames per second
        arithmetic mean (standard deviation)
    -6.54 ( 7.365 )
    -0.81 ( 6.320 )
    -8.93 ( 8.368 )
    No statistical analyses for this end point

    Secondary: Number of Subjects According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI

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    End point title
    		 Number of Subjects According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI
    End point description
    The TFG is a measure of epicardial perfusion and was graded on a standard scale from 0 to 3, where grade 0=no perfusion, grade 1=penetration without perfusion, grade 2=partial perfusion and grade 3= complete perfusion. Safety set included all subjects in the FAS who received any study treatment. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        Baseline, Grade 3
    10
    8
    9
        0 to 15 min post-PCI, Grade 3
    9
    8
    8
        0 to 15 min post-PCI, missing
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI

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    End point title
    		 Number of Subjects According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI
    End point description
    The TMPG (also known as myocardial blush grade [MBG]), is a measure of myocardial perfusion in the capillary bed at the tissues level following contrast injection into the coronary artery. TMPG was graded on a scale from 0 to 3, where grade 0 = failure of dye to enter the microvasculature; grade 1 = dye slowly enters but fails to exit the microvasculature; grade 2 = delayed entry and exit of dye from the microvasculature; grade 3= normal entry and exit of dye from the microvasculature. Only those grades with non-zero subjects have been reported. Safety set included all subjects in the FAS who received any study treatment. Combined data for Stage A and Stage B was presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        Baseline, TMPG 2
    1
    0
    1
        Baseline, TMPG 3
    7
    4
    3
        Baseline Missing
    2
    4
    5
        0 to 15 min post-PCI, TMPG value 3
    9
    6
    6
        0 to 15 min post-PCI, Missing
    1
    2
    3
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Creatine Kinase (CK)

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    End point title
    		 Change From Baseline to Post-PCI for Creatine Kinase (CK)
    End point description
    Safety Set included all subjects in the FAS who received any study treatment. Here, ‘n’ signifies number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signifies that standard deviation could not be calculated for only one subject.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Units per liter
    arithmetic mean (standard deviation)
        0 to 15 minutes post-PCI (n=10,8,9)
    -11.7 ( 11.25 )
    -6.0 ( 5.68 )
    -5.9 ( 10.58 )
        6 hours post-PCI (n=9,8,6)
    0.9 ( 17.20 )
    1.5 ( 27.07 )
    -23.5 ( 41.03 )
        24 hours post- PCI/discharge (n=6,1,3)
    -33.7 ( 23.42 )
    233.0 ( 99999 )
    -6.0 ( 38.94 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)

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    End point title
    		 Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)
    End point description
    Safety Set included all subjects in the FAS who received any study treatment. Here, ‘n’ signifies number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signified that standard deviation could not be calculated for only one subject.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Micrograms per liter
    arithmetic mean (standard deviation)
        0 to 15 minutes Post-PCI (n=10,8,8)
    -0.18 ( 0.290 )
    -0.18 ( 0.225 )
    -0.26 ( 0.490 )
        6 Hours Post-PCI (n=9,8,6)
    0.70 ( 1.260 )
    0.79 ( 2.208 )
    -0.63 ( 1.359 )
        24 Hours Post- PCI/Discharge (n=6,1,3)
    -0.05 ( 0.804 )
    31.80 ( 99999 )
    0.97 ( 0.643 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Post-PCI for Cardiac Troponin I

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    End point title
    		 Change From Baseline to Post-PCI for Cardiac Troponin I
    End point description
    Safety Set included all subjects in the FAS who received any study treatment. Here, ‘Number Analyzed’ signified number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signified that standard deviation could not be calculated for only one subject.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to administration of study treatment), anytime between 0 to15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Microgram per liter
    arithmetic mean (standard deviation)
        0-15 minutes Post-PCI (n=10,8,8)
    -0.04 ( 0.126 )
    0.01 ( 0.035 )
    0.04 ( 0.052 )
        6 Hours Post-PCI (n=9,8,6)
    0.58 ( 1.310 )
    0.13 ( 0.354 )
    0.08 ( 0.204 )
        24 Hours Post- PCI/Discharge (n=6,1,3)
    -0.03 ( 0.197 )
    5.50 ( 99999 )
    0.30 ( 0.300 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Procedural Myocardial Injury

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    End point title
    		 Number of Subjects With Procedural Myocardial Injury
    End point description
    Procedural myocardial injury was defined as elevation of cardiac troponin (cTn) values greater than (>) 99th percentile upper reference limit (URL) in subjects with normal baseline values (<= 99th percentile URL) or elevation of cTn by > 20% of the baseline value in subjects with elevated cTn levels (>99th percentile URL). Safety Set included all subjects in the FAS who received any study treatment. Combined data for Stage A and Stage B was presented as pre-specified in protocol. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here 'Number Analyzed' indicates number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    At 6 hours and 24 hours post-PCI/discharge on Day 1
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        6 Hours Post-PCI (n= 9,8,6)
    3
    1
    1
        24 Hours Post-PCI/Discharge (n=6,1,3)
    1
    1
    2
    No statistical analyses for this end point

    Secondary: Concentration of Temanogrel

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    End point title
    		 Concentration of Temanogrel [2]
    End point description
    Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL). Pharmacokinetic (PK) set included all subjects in the safety set with at least 1 post dose PK measurement. Here, ‘n’ signifies number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signifies that the data were not calculated as fewer than 50% of subjects had values above the lower limit of quantification or there were no measurable values.
    End point type
    Secondary
    End point timeframe
    Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is specific to the arms reported.
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg
    Number of subjects analysed
    10
    8
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Pre-PCI (n=9,7)
    1558.3889 ( 2156.89423 )
    1869.8571 ( 1815.65878 )
        0 to 15 minutes post PCI (n=10,6)
    126.9900 ( 31.08320 )
    265.0000 ( 109.83260 )
        1 hour post PCI (n=6,6)
    84.8667 ( 24.45278 )
    134.1667 ( 36.56455 )
        3 hours post PCI (n=6,7)
    41.8500 ( 17.23969 )
    87.1714 ( 90.12348 )
        6 hours post PCI (n=9,8)
    24.6522 ( 19.78224 )
    36.9000 ( 14.94380 )
        24 hours post-procedure/discharge (n=4,0)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Concentration of AR295980

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    End point title
    		 Concentration of AR295980 [3]
    End point description
    Observed plasma concentration of AR295980. PK set included all subjects in the safety set with at least 1 post dose PK measurement. Here, ‘n’ signifies number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signifies that the data were not calculated as fewer than 50% of subjects had values above the lower limit of quantification or there were no measurable values.
    End point type
    Secondary
    End point timeframe
    Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI, and 24 hours post PCI/discharge
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is specific to the arms reported.
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg
    Number of subjects analysed
    10
    8
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Pre-PCI (n=9,7)
    1.0472 ( 0.87240 )
    3.2010 ( 3.97562 )
        0 to 15 minutes post PCI (n=10,6)
    6.3680 ( 2.61560 )
    6.8183 ( 2.24211 )
        1 hour post PCI (n=6,6)
    5.0750 ( 1.81783 )
    8.0783 ( 4.32397 )
        3 hours post PCI (n=6,7)
    3.6933 ( 1.18230 )
    5.5300 ( 2.48489 )
        6 hours post PCI (n=9,8)
    2.4678 ( 0.79325 )
    5.2650 ( 3.21979 )
        24 hours post-PCI/discharge (n=4,0)
    0.3518 ( 0.40765 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Concentration of AR295981

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    End point title
    		 Concentration of AR295981 [4]
    End point description
    Observed plasma concentration of AR295981. PK set included all subjects in the safety set with at least 1 post dose PK measurement. All subjects reported under 'Number of Subjects Analyzed' contributed data to the table but may not have evaluable data for every row. Here, ‘n’ signified number of subjects evaluable at the specified timepoints. Combined data for Stage A and Stage B was presented as pre-specified in protocol. Here '99999' signifies that the data were not calculated as fewer than 50% of subjects had values above the lower limit of quantification or there were no measurable values.
    End point type
    Secondary
    End point timeframe
    Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI, and 24 hours post PCI/discharge
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is specific to the arms reported.
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg
    Number of subjects analysed
    10
    8
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Pre-PCI (n=9,7)
    1.8042 ( 1.11941 )
    5.9129 ( 8.69909 )
        0 to 15 minutes post PCI (n=9,6)
    0.9032 ( 0.46521 )
    1.9030 ( 1.05032 )
        1 hour post PCI (n=6,6)
    0.6743 ( 0.36798 )
    1.6575 ( 0.73395 )
        3 hours post PCI (n=6,7)
    0.4677 ( 0.37748 )
    1.0651 ( 0.32193 )
        6 hours post PCI (n=9,8)
    99999 ( 99999 )
    0.8685 ( 0.51239 )
        24 hours post-PCI/discharge (n=4,0)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity
    End point description
    An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment.TEAE was an AE that occurred after initiation of study treatment that was not present at time of treatment start or an AE that increased in severity after initiation of medication,if event was present at time of treatment start. AEs were graded according to Common Terminology Criteria for Adverse Events(CTCAE)version 4.03 as grade1:mild;grade2:moderate;grade 3:severe,grade4:life threatening,grade5:death related to AE.Number of subjects with any TEAE and grade 3 or higher TEAE have been reported.Safety set included all subjects in the FAS who received any study treatment.
    End point type
    Secondary
    End point timeframe
    From start of study treatment on day 1 to up to maximum of 10 days
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        Any TEAE
    4
    7
    4
        Grade 3 or higher TEAE
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs

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    End point title
    		 Number of Subjects with Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs
    End point description
    An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Relatedness was based on investigator's assessment. Safety set included all subjects in the FAS who received any study treatment.
    End point type
    Secondary
    End point timeframe
    From start of study treatment on day 1 to up to maximum of 10 days
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        SAEs
    0
    2
    1
        Treatment discontinuation due to adverse events
    0
    0
    0
        Treatment-Related TEAEs
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Related TEAEs According to the Preferred Term

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    End point title
    		 Number of Subjects With Treatment-Related TEAEs According to the Preferred Term
    End point description
    An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. Relatedness was based on investigator's assessment. The safety set included all subjects in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    From start of study treatment on day 1 to up to maximum of 10 days
    End point values
    		 Temanogrel 20 mg Temanogrel 40 mg Placebo
    Number of subjects analysed
    10
    8
    9
    Units: Subjects
        Vascular access site haematoma
    1
    0
    0
        Hypertension
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment on Day 1 to up to maximum of 10 days
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 subject and non-serious in other, or a subject may have experienced both serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Temanogrel 20mg
    Reporting group description
    		 Subjects received a single intravenous (IV) dose of temanogrel 20 milligram (mg) on Day 1 following which the subjects underwent percutaneous coronary intervention (PCI). Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single IV dose of placebo on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Reporting group title
    Temanogrel 40mg
    Reporting group description
    		 Subjects received a single IV dose of temanogrel 40mg on Day 1 following which the subjects underwent PCI. Subjects had a follow-up phone call 7 days after administration of study treatment.

    Serious adverse events
    		 Temanogrel 20mg Placebo Temanogrel 40mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Vascular access site haematoma
    alternative dictionary used: Medra v24.0 24.0
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
    alternative dictionary used: Medra v24.0 24.0
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         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 disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Temanogrel 20mg Placebo Temanogrel 40mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    3 / 9 (33.33%)
    7 / 8 (87.50%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Vascular access site haematoma
         subjects affected / exposed
    4 / 10 (40.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    4
    1
    1
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Cardiac arrest
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Cardiogenic shock
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Coronary artery dissection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Congestive hepatopathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2020
    Dosage and administration of study intervention was updated and procedures for collection of PK blood samples were updated.
    17 May 2022
    Changes to the frequency of blood collections and clarification regarding the allowed timing of Baseline coronary physiology indices.

    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.
    This study was terminated early due to a business decision that was not due to any safety concerns. The number of subjects was smaller than originally planned and only summary statistics were therefore generated for primary and secondary endpoints.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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