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    Clinical Trial Results:
    Platelet Function and Treatment with ASA in patients with Essential Thrombocytosis

    Summary
    EudraCT number
    		 2015-002798-39
    Trial protocol
    		 DK  
    Global end of trial date
    14 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2017
    First version publication date
    22 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2015050991
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Coordinator, Aarhus University Hospital, +45 78450000, madslr@rm.dk
    Scientific contact
    Coordinator, Aarhus University Hospital, +45 78450000, madslr@rm.dk
    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
    05 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The project aims to examine why patients with the disease essential thrombocytosis (ET) are at increased risk of thrombosis, and then to examine if their treatment with ASA can be improved.
    Protection of trial subjects
    The study was conducted in accordance with the Helsinki II Declaration and Guidelines for Good Clinical Practice (IHC-GCP). The study protocol was approved by the Central Denmark Region Committees on Biomedical Research Ethics, the Danish Medicines Agency and the Danish Data Protection Agency (EudraCT #2015-002798-39). The study was monitored by the Unit for Good Clinical Practice, Aarhus University, Denmark. Written informed consent was obtained from all participants.
    Background therapy
    		 PPI: (Pantoprazol , Esomeprazol ) Cytoreductive therapy: (hydroxyurea) Antihypertensive therapy: Ancosan comp, Cozaar, Amlodipin, enalapril, atenolol, Norvasc, corodil comp, Metropolol) Statins: (simvastatin) Other medication: Alendronat, Fish oil, allopurinol, Eltroxin, letrozol, estradiol, Fluicintin, Brikanyl, Kaleorid, noritren, Tramadol, Imozop, paracetamol)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    9
    From 65 to 84 years
    15
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were identified at the Department of Hematology, Aarhus University Hospital, Denmark in january 2016.

    Pre-assignment
    Screening details
    		 The screening were preformed in accordance with the in-and exclusions criteria. A total of 189 patients were eligible for inclusion. 129 patients did not meet the in - or exclusion criteria. 60 patients were invited to the study and 25 patients rejected, leaving a study population of 25 patients.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ET patients
    Arm description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4. This study was non-randomised. Baseline data was compared with heathy voulenteers and period 3 + 4 was compared as paired data.
    Arm type
    		 No intervension

    Investigational medicinal product name
    ASS Gamma 75 mg Tablets
    Investigational medicinal product code
    ACT code: B01AC06
    Other name
    Aspirin/ASA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were asked to discontinue ASA for 14 days prior to blood sampling

    Number of subjects in period 1
    		ET patients
    Started
    25
    Completed
    24
    Not completed
    1
         Adverse event, non-fatal
    1
    Period 2
    Period 2 title
    healthy indviduals
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 healthy individuals
    Arm description
    		 These patients are not enrolled in the trial, but used to compare with enrolled patients in the endpoints
    Arm type
    		 Healthy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		healthy individuals
    Started
    24
    Completed
    24
    Period 3
    Period 3 title
    Visit 2 (ASA 75 mg x 1)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ASA 75 mg x 1
    Arm description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASS Gamma 75 mg Tablets
    Investigational medicinal product code
    ACT code: B01AC06
    Other name
    Aspirin/ASA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were asked to take ASS gamma 75 mg once-daily for 7 days

    Number of subjects in period 3
    		ASA 75 mg x 1
    Started
    24
    Completed
    22
    Not completed
    2
         Protocol deviation
    2
    Period 4
    Period 4 title
    visit 3 (ASA 37.5 mg x 2)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ASA 37.5 mg x 2
    Arm description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASS Gamma 75 mg Tablets
    Investigational medicinal product code
    ACT code: B01AC06
    Other name
    Aspirin/ASA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    After 14 days washout, patients were asked to take ASS gamma 37.5 mg twice-daily for 7 days

    Number of subjects in period 4
    		ASA 37.5 mg x 2
    Started
    22
    Completed
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 13 13
        85 years and over
    		 1 1
        not recorded
    		 1 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 67 (55 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    ET patients
    Reporting group description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4. This study was non-randomised. Baseline data was compared with heathy voulenteers and period 3 + 4 was compared as paired data.
    Reporting group title
    healthy individuals
    Reporting group description
    		 These patients are not enrolled in the trial, but used to compare with enrolled patients in the endpoints
    Reporting group title
    ASA 75 mg x 1
    Reporting group description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4.
    Reporting group title
    ASA 37.5 mg x 2
    Reporting group description
    		 All patients enrolled in the study went through all periods created except for the period heathy voulenteers. This was the most proper way to create this design in this interface. Thus all patient went through period 1 + 3 + 4.

    Primary: Difference in the nadir value of TXB2 at the end of the dosing interval (24h blood sample) between the once-daily and twice-daily regimen.

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    End point title
    		 Difference in the nadir value of TXB2 at the end of the dosing interval (24h blood sample) between the once-daily and twice-daily regimen.
    End point description
    We compared TXB2 values after intake of aspirin 75 mg once-daily for seven days with the values after intake of aspirin 37.5 mg twice-daily. Due to the interface of this website it is created as two arms (otherwise errors occured). But the statistical method used was a paired t-test, thus the same patients went though both regimens.
    End point type
    Primary
    End point timeframe
    blood sampling after visit 2 and after visit 3.
    End point values
    		 ASA 75 mg x 1 ASA 37.5 mg x 2
    Number of subjects analysed
    22
    22
    Units: ng/mL
        arithmetic mean (standard deviation)
    29.6 ± 19.1
    15.7 ± 12.6
    Statistical analysis title
    		 paired t-test
    Statistical analysis description
    In this interface, the design of the study is created as arms suggesting different subjects for analysis in each arm. However, the intension was a paired analysis with 22 subjects going though the two different periods (period 3 and 4).
    Comparison groups
    ASA 75 mg x 1 v ASA 37.5 mg x 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.9
         upper limit
    		 27.7
    Notes
    [1] - Paired t test with 22 subjects (not 44 as stated).

    Primary: difference in IPC between ET patients and healthy individuals

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    End point title
    		 difference in IPC between ET patients and healthy individuals
    End point description
    End point type
    Primary
    End point timeframe
    Measured at the baseline blood sample
    End point values
    		 ET patients healthy individuals
    Number of subjects analysed
    24
    24
    Units: 10<9>/ L blood
        median (inter-quartile range (Q1-Q3))
    12.3 (9.7 to 18.7)
    6.9 (5.5 to 10.3)
    Statistical analysis title
    		 unpaired t-test
    Comparison groups
    ET patients v healthy individuals
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 7.5

    Secondary: difference in IPF between health and ET patients

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    End point title
    		 difference in IPF between health and ET patients
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline period
    End point values
    		 ET patients healthy individuals
    Number of subjects analysed
    24
    24
    Units: %
        median (inter-quartile range (Q1-Q3))
    2.8 (2.3 to 3.4)
    2.6 (2.1 to 3.9)
    Statistical analysis title
    		 unpaired mann whitney
    Comparison groups
    ET patients v healthy individuals
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.6

    Secondary: Difference in MPV between ET patients and healthy individuals

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    End point title
    		 Difference in MPV between ET patients and healthy individuals
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline period
    End point values
    		 ET patients healthy individuals
    Number of subjects analysed
    24
    24
    Units: fL
        median (inter-quartile range (Q1-Q3))
    10.1 (9.4 to 10.5)
    10.4 (10.1 to 10.8)
    Statistical analysis title
    		 unpaired mann whitney
    Comparison groups
    ET patients v healthy individuals
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study perioud between march and sebtember 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1.36.1
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 Blood samples were obtained at baseline (off treatment blood sample), at visit 2 (after 7 days treatment of aspirin 75 mg once-daily) and at visit 3 (after 7 days treatment of aspirin 37.5 mg twice-daily).

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    TIA
    Additional description: transient ischemic attack
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    During the study, we experienced difficulties with recruiting a sufficient number of patients and ended up with a study population of 22-24 patients.
    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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