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    Clinical Trial Results:
    The effect of clopidogrel and ticagrelor with and without acetylsalicylic acid (ASA) on hemostatic system activation at the site of plug formation in vivo in man

    Summary
    EudraCT number
    		 2010-019643-19
    Trial protocol
    		 AT  
    Global end of trial date
    19 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2020
    First version publication date
    25 Apr 2020
    Other versions
    Summary report(s)
    		 Effects of clopidogrel with or without aspirin on the generation of extracellular vesicles in the microcirculation and in venous blood: A randomized placebo controlled trial.
    Effects of P2Y12 receptor inhibition with or without aspirin on hemostatic system activation: a randomized trial in healthy subjects.
    Differential Effects of Ticagrelor With or Without Aspirin on Platelet Reactivity and Coagulation Activation: A Randomized Trial in Healthy Volunteers

    Trial information

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    Trial identification
    Sponsor protocol code
    9/27/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02120092
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringerguertel 18-20, Vienna, Austria, 1090
    Public contact
    Medical University of Vienna Department of Medicine I, Medical University of Vienna Department of Medicine I, +43 14040044100, sabine.eichinger@meduniwien.ac.at
    Scientific contact
    Ao. Univ. Prof. Dr. Sabine Eichinger, Medical University of Vienna Department of Medicine I, +43 14040044100, sabine.eichinger@meduniwien.ac.at
    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 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - to compare the effects of clopidogrel and ticagrelor on in vivo and ex vivo hemostatic system activation - to investigate the additional effect of ASA to clopidogrel or ticagrelor with regard to their effects on in vivo and ex vivo hemostatic system activation
    Protection of trial subjects
    subjects were encouraged to report any discomfort, pain, or other change to their physical intactness. subjects were particularly instructed to record any bleeding (including nose bleeds, hematoma, wet purpura, blood in stool or urine).
    Background therapy
    		 none
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 88
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    88
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted as a randomized, parallelgroup, double-blind, placebo-controlled trial between November 2011 and December 2013 at the Departments of Medicine I and Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.

    Pre-assignment
    Screening details
    		 Inclusion criteria: healthy, male, non-smoking volunteers (18–50 yrs) Exclusion criteria: history of bleeding, bleeding risk, obesity, allergy to IP, known GI disease, significant finding in physical or laboratory examination, alcohol abuse, medication use within 2 weeks before study start

    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
    Blinding implementation details
    Randomization was performed by the method of permuted blocks with a block size of four. A person not directly involved in study-related procedures performed concealment of the respective drugs. Investigators involved in the study were not aware of the randomization code, which was broken after finalizing the study and all laboratory analyses were completed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Clopidogrel + aspirin
    Arm description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with 100 mg aspirin followed by 150 mg clopidogrel together with 100 mg aspirin from day 2 until day 7.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel + aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Clopidogrel 600 mg + Aspirin 100 mg Day 2 - day 7: Clopidogrel 150 mg + Aspirin 100 mg

    Arm title
    		 Clopidogrel + placebo
    Arm description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with placebo followed by 150 mg clopidogrel together with placebo from day 2 until day 7.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Clopidogrel + placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Clopidogrel 600 mg + placebo Day 2-7: Clopidogrel 150 mg + placebo

    Arm title
    		 Ticagrelor + aspirin
    Arm description
    		 Day 1: Ticagrelor 180 mg + aspirin 300 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ticagrelor + aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Ticagrelor 180 mg + aspirin 300 mg

    Arm title
    		 Ticagrelor + placebo
    Arm description
    		 Day 1: Ticagrelor 180 mg + placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ticagrelor + placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: Ticagrelor 180 mg + placebo

    Number of subjects in period 1
    		Clopidogrel + aspirin Clopidogrel + placebo Ticagrelor + aspirin Ticagrelor + placebo
    Started
    23
    21
    22
    22
    Completed
    23
    21
    22
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Clopidogrel + aspirin
    Reporting group description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with 100 mg aspirin followed by 150 mg clopidogrel together with 100 mg aspirin from day 2 until day 7.

    Reporting group title
    Clopidogrel + placebo
    Reporting group description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with placebo followed by 150 mg clopidogrel together with placebo from day 2 until day 7.

    Reporting group title
    Ticagrelor + aspirin
    Reporting group description
    		 Day 1: Ticagrelor 180 mg + aspirin 300 mg

    Reporting group title
    Ticagrelor + placebo
    Reporting group description
    		 Day 1: Ticagrelor 180 mg + placebo

    Reporting group values
    		 Clopidogrel + aspirin Clopidogrel + placebo Ticagrelor + aspirin Ticagrelor + placebo Total
    Number of subjects
    		 23 21 22 22 88
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
        adults (18 - 50 years)
    		 23 21 22 22 88
    Gender categorical
    young, healthy, male volunteers
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 23 21 22 22 88

    End points

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    End points reporting groups
    Reporting group title
    Clopidogrel + aspirin
    Reporting group description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with 100 mg aspirin followed by 150 mg clopidogrel together with 100 mg aspirin from day 2 until day 7.

    Reporting group title
    Clopidogrel + placebo
    Reporting group description
    		 On day 1, volunteers received 600 mg clopidogrel (Plavix; Sanofi Pharma Bristol-Myers Squibb, Paris, France) together with placebo followed by 150 mg clopidogrel together with placebo from day 2 until day 7.

    Reporting group title
    Ticagrelor + aspirin
    Reporting group description
    		 Day 1: Ticagrelor 180 mg + aspirin 300 mg

    Reporting group title
    Ticagrelor + placebo
    Reporting group description
    		 Day 1: Ticagrelor 180 mg + placebo

    Primary: beta-thromboglobulin in microvascular blood

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    End point title
    		 beta-thromboglobulin in microvascular blood
    End point description
    End point type
    Primary
    End point timeframe
    Difference between baseline levels and levels 2 hours after first intake of study medication
    End point values
    		 Clopidogrel + aspirin Clopidogrel + placebo Ticagrelor + aspirin Ticagrelor + placebo
    Number of subjects analysed
    23
    21
    22
    22
    Units: international unit(s)/litre
        median (inter-quartile range (Q1-Q3))
    2.6 (2.3 to 4.5)
    2.6 (1.8 to 3.4)
    1.7 (1.2 to 2.9)
    1.8 (1.2 to 2.6)
    Statistical analysis title
    		 unpaired t-test
    Statistical analysis description
    the unpaired t-test was used comparing baseline measurements with values after 2 hours.
    Comparison groups
    Clopidogrel + aspirin v Clopidogrel + placebo v Ticagrelor + aspirin v Ticagrelor + placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Clopdidogrel + aspirin: 8 days Clopidogrel + placebo: 8 days Ticagrelor + aspirin: 2 days Ticagrelor + placebo: 2 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Clopdidogrel + aspirin: 8 days
    Reporting group description
    		 Clopdidogrel + aspirin: 8 days

    Serious adverse events
    		 Clopdidogrel + aspirin: 8 days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Clopdidogrel + aspirin: 8 days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    Blood and lymphatic system disorders
    Epistaxis
    Additional description: One volunteer had nose bleeding for ~1 min and a hematoma on the thigh ~7 cm in diameter. He was treated with clopidogrel and aspirin, reported to the study center on day 8, completed treatment, and did not receive a specific therapy.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Haematoma
    Additional description: One volunteer had nose bleeding for ~1 min and a hematoma on the thigh ~7 cm in diameter. He was treated with clopidogrel and aspirin, reported to the study center on day 8, completed treatment, and did not receive a specific therapy.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Sep 2012
    Change of one tested substance: ticagrelor instead of prasugrel

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26663880
    http://www.ncbi.nlm.nih.gov/pubmed/29857271
    http://www.ncbi.nlm.nih.gov/pubmed/31442298
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