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    Clinical Trial Results:
    Does Ticagrelor inhibit growth of small abdominal aortic aneurysms? A randomised controlled trial (TicAAA)

    Summary
    EudraCT number
    		 2013-002736-24
    Trial protocol
    		 SE  
    Global end of trial date
    26 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2018
    First version publication date
    27 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TicAAA-1.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala University Hospital
    Sponsor organisation address
    Akademiska sjukhuset ing 70, 1 tr, Uppsala, Sweden,
    Public contact
    Anders Wanhainen, Uppsala University Hospital, anders.wanhainen@surgsci.uu.se
    Scientific contact
    Anders Wanhainen, Uppsala University Hospital, anders.wanhainen@surgsci.uu.se
    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
    26 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of Ticagrelor on Abdominal aortic aneurysm (AAA)-expansion in a multi-centre, randomized, double-blinded for Ticagrelor and placebo.
    Protection of trial subjects
    Patients were given full and adequate verbal and written information about the objectives, procedures and possible risks and benefits of the study, prior to enrolment. Study treatment was to be stopped in case of liver impairment, severe bleeding, elective aneurysm surgery, or the onset of any exclusion criteria. In the case of trauma during the study, the study drug was to be discontinued until the risk of bleeding ends.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2014
    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
    Sweden: 144
    Worldwide total number of subjects
    144
    EEA total number of subjects
    144
    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)
    6
    From 65 to 84 years
    138
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 158 patients were enrolled in the study. Of these, there were 14 enrolment failures due to 7 patients who did not satisfy inclusion criteria #4 (documented AAA 35-49mm), 4 patients failing various exclusion criteria, and 3 patients who left by choice.

    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
    The active product and placebo were identical in appearance and packed in identical, non-transparent containers. Sealed envelopes with individual treatment codes showing allocated treatment for each randomised patient was kept by the PI, local pharmacy, and the Sponsor's safety department. The treatment code was not to be broken except in medical emergencies. Any breaking of the treatment code had to be documented.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ticagrelor
    Arm description
    		 Ticagrelor 90 mg tablet twice daily for 12 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    SUB30898
    Other name
    Brilique
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg tablet twice daily for 12 months

    Arm title
    		 Placebo
    Arm description
    		 Ticagrelor placebo tablet twice daily for 12 months
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ticagrelor placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ticagrelor placebo tablet twice daily for 12 months

    Number of subjects in period 1
    		Ticagrelor Placebo
    Started
    72
    72
    Completed
    67
    67
    Not completed
    5
    5
         Adverse event, serious fatal
    -
    2
         Physician decision
    1
    -
         Elective aneurysm surgery
    1
    -
         Adverse event, non-fatal
    3
    1
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ticagrelor
    Reporting group description
    		 Ticagrelor 90 mg tablet twice daily for 12 months

    Reporting group title
    Placebo
    Reporting group description
    		 Ticagrelor placebo tablet twice daily for 12 months

    Reporting group values
    		 Ticagrelor Placebo Total
    Number of subjects
    		 72 72 144
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.5 ( 4.6 ) 68.3 ( 4.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 2 6
        Male
    		 68 70 138
    Race
    Units: Subjects
        White
    		 71 70 141
        Other
    		 1 2 3
    Tobacco usage
    Smoking at enrollment was reported as never smoked, current smoker, or former smoker.
    Units: Subjects
        Current
    		 22 26 48
        Former
    		 40 39 79
        Never
    		 10 7 17
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 86.3 ( 12.5 ) 88.1 ( 14.6 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 177.6 ( 7.7 ) 179.4 ( 6.6 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.39 ( 3.74 ) 27.31 ( 3.84 ) -
    Subject analysis sets

    Subject analysis set title
    Ticagrelor (PPA)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPA population was pre-defined in the study protocol as patients with at least 80% compliance with the intended use, no major protocol deviations and with measure of primary efficacy endpoint at 12 months after randomisation.

    Subject analysis set title
    Placebo (PPA)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPA population was pre-defined in the study protocol as patients with at least 80% compliance with the intended use, no major protocol deviations and with measure of primary efficacy endpoint at 12 months after randomisation.

    Subject analysis set title
    Ticagrelor (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population was pre-defined that patients with no post-dose observations for an efficacy endpoint should be removed from the ITT population.

    Subject analysis set title
    Placebo (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population was pre-defined that patients with no post-dose observations for an efficacy endpoint should be removed from the ITT population.

    Subject analysis sets values
    		 Ticagrelor (PPA) Placebo (PPA) Ticagrelor (ITT) Placebo (ITT)
    Number of subjects
    55
    63
    69
    70
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.4 ( 4.5 )
    68.7 ( 4.2 )
    69.5 ( 4.5 )
    68.3 ( 4.2 )
    Gender categorical
    Units: Subjects
        Female
    2
    2
    4
    2
        Male
    53
    61
    65
    68
    Race
    Units: Subjects
        White
    54
    62
    68
    68
        Other
    1
    1
    1
    2
    Tobacco usage
    Smoking at enrollment was reported as never smoked, current smoker, or former smoker.
    Units: Subjects
        Current
    13
    23
    21
    25
        Former
    32
    34
    38
    39
        Never
    10
    6
    10
    6
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    87.0 ( 12.4 )
    87.8 ( 14.7 )
    86.2 ( 12.4 )
    88.2 ( 14.8 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    177.9 ( 7.8 )
    179.1 ( 6.7 )
    177.6 ( 7.8 )
    179.3 ( 6.6 )
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.51 ( 3.79 )
    27.32 ( 3.88 )
    27.33 ( 3.75 )
    27.38 ( 3.88 )

    End points

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    End points reporting groups
    Reporting group title
    Ticagrelor
    Reporting group description
    		 Ticagrelor 90 mg tablet twice daily for 12 months

    Reporting group title
    Placebo
    Reporting group description
    		 Ticagrelor placebo tablet twice daily for 12 months

    Subject analysis set title
    Ticagrelor (PPA)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPA population was pre-defined in the study protocol as patients with at least 80% compliance with the intended use, no major protocol deviations and with measure of primary efficacy endpoint at 12 months after randomisation.

    Subject analysis set title
    Placebo (PPA)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPA population was pre-defined in the study protocol as patients with at least 80% compliance with the intended use, no major protocol deviations and with measure of primary efficacy endpoint at 12 months after randomisation.

    Subject analysis set title
    Ticagrelor (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population was pre-defined that patients with no post-dose observations for an efficacy endpoint should be removed from the ITT population.

    Subject analysis set title
    Placebo (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population was pre-defined that patients with no post-dose observations for an efficacy endpoint should be removed from the ITT population.

    Primary: Difference in log-transformed volume of Abdominal Aortic Aneurysm (AAA) determined by magnetic resonance imaging (MRI) at 12 months

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    End point title
    		 Difference in log-transformed volume of Abdominal Aortic Aneurysm (AAA) determined by magnetic resonance imaging (MRI) at 12 months
    End point description
    The analysis performed on the ITT population was an Analysis of Covariance (ANCOVA) model with difference in log-transformed AAA volume at 12 month - baseline as response variable. Treatment (Ticagrelor vs. Placebo) was included as a fixed factor in the ANCOVA model and log-transformed baseline AAA volume was included as a covariate. Missing outcomes were imputed using last-value-carried-forward (LVCF), excluding patients with no post-baseline measurement. The result were presented as the estimated geometric mean ratio Ticagrelor/Placebo, with 95% C.I. and two-sided p-value. AAA volume increase was similar in both arms, and there was no indication of a systemic difference between the treatments. The results of the secondary outcomes were in line with the primary variable.
    End point type
    Primary
    End point timeframe
    Mean 12 months AAA volume increase from baseline (6 month values carried forward)
    End point values
    		 Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    67
    69
    Units: cm3
        geometric mean (confidence interval 95%)
    1.091 (1.074 to 1.109)
    1.075 (1.061 to 1.090)
    Statistical analysis title
    		 Analysis of difference in AAA volume by MRI
    Statistical analysis description
    The primary outcome was baseline-adjusted AAA volume at 12 months in the ITT population analysed using an ANCOVA model with difference in log-transformed AAA volume at 12 month - baseline as response variable. Treatment (Ticagrelor vs. Placebo) was included as a fixed factor in the ANCOVA model and log-transformed baseline AAA volume was included as a covariate.
    Comparison groups
    Placebo (ITT) v Ticagrelor (ITT)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.205
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Missing outcomes were imputed using last-value-carried-forward (LVCF), excluding patients with no post-baseline measurement.

    Secondary: Difference in AAA diameter determined by MRI at 12 months vs at baseline

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    End point title
    		 Difference in AAA diameter determined by MRI at 12 months vs at baseline
    End point description
    67 Ticagrelor patients and 69 placebo patients were included in the ITT analysis, of which data for 2 Ticagrelor and 3 placebo patients were imputed using the 6-months value. Mean 12 months AAA diameter increase from baseline was 0.24 cm in the Ticagrelor treatment group and 0.18 cm in the placebo group, not affected by imputation.
    End point type
    Secondary
    End point timeframe
    Mean 12 months AAA diameter increase from baseline (6 month values carried forward) determined by magnetic resonance imaging (MRI)
    End point values
    		 Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    67 [2]
    69 [3]
    Units: cm
        arithmetic mean (confidence interval 95%)
    0.244 (0.190 to 0.298)
    0.185 (0.142 to 0.227)
    Notes
    [2] - 67 Ticagrelor patients were included, of which data for 2 were imputed using the 6-months value.
    [3] - 69 Placebo patients were included, of which data for 3 were imputed using the 6-months value.
    No statistical analyses for this end point

    Secondary: Difference in AAA diameter determined by ultrasound (US) at 12 months vs at baseline

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    End point title
    		 Difference in AAA diameter determined by ultrasound (US) at 12 months vs at baseline
    End point description
    69 Ticagrelor patients and 70 placebo patients were included in the ITT analysis, of which data for 2 Ticagrelor and 3 placebo patients were imputed using the 6-months value. Mean 12 months AAA diameter increase from baseline was 2.3 mm in the Ticagrelor treatment group and 2.2 mm in the placebo group, not affected by imputation.
    End point type
    Secondary
    End point timeframe
    Mean 12 months AAA diameter increase from baseline (6 month values carried forward) determined by ultrasound (US)
    End point values
    		 Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    69 [4]
    70 [5]
    Units: mm
        arithmetic mean (confidence interval 95%)
    2.29 (1.68 to 2.90)
    2.17 (1.65 to 2.70)
    Notes
    [4] - 69 Ticagrelor patients were included, of which 2 patients were imputed using the 6-months value.
    [5] - 70 Placebo patients were included, of which 3 patients were imputed using the 6-months value.
    No statistical analyses for this end point

    Secondary: Difference in thrombus volume determined by MRI at 12 months vs at baseline

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    End point title
    		 Difference in thrombus volume determined by MRI at 12 months vs at baseline
    End point description
    67 Ticagrelor patients and 69 placebo patients were included in the ITT analysis, of which data for 2 Ticagrelor and 3 placebo patients were imputed using the 6-months value.
    End point type
    Secondary
    End point timeframe
    Mean 12 months thrombus volume increase from baseline (6 month values carried forward) determined by MRI
    End point values
    		 Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    67 [6]
    69 [7]
    Units: cm3
        geometric mean (confidence interval 95%)
    1.130 (1.075 to 1.187)
    1.109 (1.066 to 1.155)
    Notes
    [6] - 67 Ticagrelor patients were included, of which 2 patients were imputed using the 6-months value.
    [7] - 69 Placebo patients were included, of which 3 patients were imputed using the 6-months value.
    No statistical analyses for this end point

    Secondary: Difference in need for surgery (≥ 55 mm) after 12 months

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    End point title
    		 Difference in need for surgery (≥ 55 mm) after 12 months
    End point description
    Need for surgery defined as aortic diameter 55 mm or larger, or reported need for surgery at 6 or 12 months ultrasound, or withdrawal from study due to need for surgery is presented for the ITT and PPA populations at 12 months.
    End point type
    Secondary
    End point timeframe
    Difference in need for surgery (≥ 55 mm) after 12 months
    End point values
    		 Ticagrelor (PPA) Placebo (PPA) Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    55
    63
    69
    70
    Units: Number of subjects
    2
    0
    4
    0
    No statistical analyses for this end point

    Secondary: Difference in aneurysm rupture after 12 months

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    End point title
    		 Difference in aneurysm rupture after 12 months
    End point description
    Aneurysm rupture was recorded in the US CRF. In case an aneurysm rupture was detected as an AE it was added to the CRF-reported events. Patients that withdrew from follow-up without having an event were counted as no event. There were no aneurysm ruptures recorded in the study.
    End point type
    Secondary
    End point timeframe
    Difference in aneurysm rupture after 12 months
    End point values
    		 Ticagrelor (PPA) Placebo (PPA) Ticagrelor (ITT) Placebo (ITT)
    Number of subjects analysed
    55
    63
    69
    70
    Units: Number of subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were recorded from the enrolment visit (visit 1) and SAEs/AEs were recorded from the baseline visit (visit 2) until the last visit (12 months after the baseline visit).
    Adverse event reporting additional description
    SAEs were continuously recorded in the eCRF from visit 1 and SAE+AE were recorded from visit 2. All included patients were informed to contact the site if they experienced any more than normal bleeding and/or any liver impairment during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD-10
    Dictionary version
    2016
    Reporting groups
    Reporting group title
    Ticagrelor
    Reporting group description
    		 Ticagrelor 90 mg tablet twice daily for 12 months

    Reporting group title
    Placebo
    Reporting group description
    		 Ticagrelor placebo tablet twice daily

    Serious adverse events
    		 Ticagrelor Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 72 (6.94%)
    7 / 72 (9.72%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fracture of clavicle
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture of other parts of lower leg
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Acute vascular disorders of intestine
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest, unspecified
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Atrial fibrillation and atrial flutter, unspecified
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia, unspecified
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Other and unspecified medical devices associated with adverse incidents
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Haemorrhage, not elsewhere classified
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain, not elsewhere classified
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope and collapse
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock, unspecified
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Other specified disorders of male genital organs
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Paraesthesia of skin
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depressive episode, unspecified
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Retention of urine
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ticagrelor Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 72 (79.17%)
    38 / 72 (52.78%)
    General disorders and administration site conditions
    Haemorrhage, not elsewhere classified
         subjects affected / exposed
    22 / 72 (30.56%)
    8 / 72 (11.11%)
         occurrences all number
    33
    11
    Dyspnoea
         subjects affected / exposed
    19 / 72 (26.39%)
    4 / 72 (5.56%)
         occurrences all number
    19
    4
    Respiratory, thoracic and mediastinal disorders
    Acute nasopharyngitis
         subjects affected / exposed
    4 / 72 (5.56%)
    2 / 72 (2.78%)
         occurrences all number
    4
    3

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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.
    None reported
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