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    Clinical Trial Results:
    REstart or STop Antithrombotics Randomised Trial (RESTART)

    Summary
    EudraCT number
    2012-003190-26
    Trial protocol
    GB  
    Global end of trial date
    10 Feb 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Sep 2021
    First version publication date
    19 Sep 2021
    Other versions
    Summary report(s)
    RESTART Lancet Main Results
    RESTART Lancet Imaging results
    Results of final extended follow-up of RESTART

    Trial information

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    Trial identification
    Sponsor protocol code
    RESTART13
    Additional study identifiers
    ISRCTN number
    ISRCTN71907627
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Academic and Clinical Central Office for Research and Development (ACCORD)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Head of Research Governance , Academic and Clinical Central Office for Research and Development (ACCORD), +44 0131 242 3330, enquiries@accord.scot
    Scientific contact
    Professor Rustam Al-Shahi Salman, University of Edinburgh, +44 0131 242 7014, rustam.al-shahi@ed.ac.uk
    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
    31 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Research question: For adults surviving spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, does a policy of starting antiplatelet drugs result in a beneficial net reduction of all serious vascular events compared with a policy of avoiding antiplatelet drugs? Primary objective of the pilot phase: To estimate the relative and absolute effects of antiplatelet drugs on the risk of recurrent symptomatic ICH associated with a policy of starting antiplatelet drugs after the acute phase of spontaneous ICH. This entry on EudraCT relates to the main results of the trial, published in 2019. This entry also includes the final results after 2-year extended follow-up, published in 2021, as a summary attachment.
    Protection of trial subjects
    RESTART was conducted in accordance with all relevant data protection, ethical and regulatory requirements to ensure the privacy and security of patient information and to ensure the rights, safety and well-being of the patients and the quality of the research data. We sought support and advice from members of the patient reference group for the Research to Understand Stroke due to Haemorrhage (RUSH) programme for ongoing review of our study materials and on trial progress. We also included a member of this group as part of our Independent Steering Group. We sought to minimise risk and the burden to the patient without compromising the scientific rigour of the trial. Risk was minimised by excluding patients in whom the risks were likely to be the greatest e.g. patients on anticoagulation. Annual follow-up questionnaires were kept to a minumum to avoid burden and a central helpline was available to support participants, families, general practitioners (GPs) and research staff.
    Background therapy
    Any background therapy was determined for participants by the clinical teams at each of our 104 hospital sites.
    Evidence for comparator
    The intervention in RESTART was standard care and antiplatelet therapy (any of aspirin, clopidogrel, or dipyridamole); the comparator was standard care without antiplatelet therapy. The Antithrombotic Trialists’ Collaboration meta-analysis of randomised controlled trials found that aspirin use for the secondary prevention of occlusive vascular disease reduces risk of major vascular events, even though it might increase the risk of intracranial haemorrhage (a composite of intracerebral, subarachnoid, or subdural haemorrhages). However, these trials excluded patients with intracerebral haemorrhage, the commonest subtype of intracranial haemorrhage with the worst outcome. We searched the Cochrane Stroke Group Register, the Cochrane Central Register of Controlled Trials, Ovid MEDLINE (from 1948), Ovid Embase (from 1980), online registries of clinical trials, and bibliographies of relevant publications on Jan 28, 2019, for randomised controlled trials of starting versus avoiding antiplatelet therapy after intracerebral haemorrhage, from database inception until Jan 28, 2019, without language restrictions. We found no completed randomised controlled trials. A meta-analysis of observational studies found no difference in the risk of haemorrhagic events and a lower risk of occlusive vascular events associated with antiplatelet therapy resumption after any type of intracranial haemorrhage.
    Actual start date of recruitment
    04 Mar 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy, Scientific research
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 537
    Worldwide total number of subjects
    537
    EEA total number of subjects
    0
    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)
    86
    From 65 to 84 years
    376
    85 years and over
    75

    Subject disposition

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    Recruitment
    Recruitment details
    Between May 22, 2013, and May 31, 2018, 562 patients were consented and 537 enrolled in 104 of 122 UK hospitals. 25 patients were not enrolled; 6 were ineligible; 7 had deterioration of health condition; in 11 cases the patients, clinician, carer or family member were not uncertain about antiplatelet use and 1 consented after recruitment ended.

    Pre-assignment
    Screening details
    RESTART did not require sites to collect information about patients screened for eligibility, however we analysed screening logs at sites that kept them and published the results in Trials 2017;18:162 (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1909-4).

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Staff following up the participants at the trial coordinating centre were masked to treatment allocation. Outcome event adjudicators were masked to participant identity, treatment allocation, and drug use.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Start Antiplatelet
    Arm description
    The intervention of starting antiplatelet therapy was restricted to the use of one or more of oral aspirin, dipyridamole, or clopidogrel, begun within 24 h of randomisation with doses determined at the discretion of the consultant responsible for the participant.
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    As instructed by clinician

    Investigational medicinal product name
    Dipyridamole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    As directed by clinician

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    As prescribed by randomising clinician

    Arm title
    Avoid Antiplatelet
    Arm description
    The comparator was a policy of avoiding antiplatelet therapy. Participants were permitted to start or discontinue antiplatelet or anticoagulant therapy if clinically indicated by events during follow-up, regardless of treatment allocation.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Start Antiplatelet Avoid Antiplatelet
    Started
    268
    269
    Completed
    268
    268
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Start Antiplatelet
    Reporting group description
    The intervention of starting antiplatelet therapy was restricted to the use of one or more of oral aspirin, dipyridamole, or clopidogrel, begun within 24 h of randomisation with doses determined at the discretion of the consultant responsible for the participant.

    Reporting group title
    Avoid Antiplatelet
    Reporting group description
    The comparator was a policy of avoiding antiplatelet therapy. Participants were permitted to start or discontinue antiplatelet or anticoagulant therapy if clinically indicated by events during follow-up, regardless of treatment allocation.

    Reporting group values
    Start Antiplatelet Avoid Antiplatelet Total
    Number of subjects
    268 269 537
    Age categorical
    At baseline, participants in the two treatment groups were on average 76 years old
    Units: Subjects
        <70 years
    73 73 146
        ≥ 70 years
    195 196 391
    Age continuous
    Age Overall (median)
    Units: years
        median (inter-quartile range (Q1-Q3))
    77.0 (69.0 to 82.0) 76.0 (69.0 to 82.0) -
    Gender categorical
    As in many other randomised trials of intracerebral haemorrhage, most participants were male, which might be because of their propensity to be invited or consent rather than differences in incidence or outcome of intracerebral haemorrhage compared with women.
    Units: Subjects
        Female
    95 82 177
        Male
    173 187 360
    Ethnicity
    Units: Subjects
        White
    251 242 493
        Asian
    12 18 30
        Black
    4 5 9
        Other
    1 4 5
    Probability of good 6-month outcome
    Predicted probability of being alive and independent at 6 months. See Counsell C, Dennis M, McDowall M, Warlow C. Predicting outcome after acute and subacute stroke: development and validation of new prognostic models. Stroke 2002; 33(4):1041-1047
    Units: Subjects
        <0.15
    48 51 99
        >=0.15
    220 218 438
    Location of intracerebral haemorrhage
    Units: Subjects
        Non-Lobar
    102 103 205
        Lobar
    166 166 332
    Time since ICH symptom onset to randomisation Groups
    Units: Subjects
        0-6 days
    10 11 21
        7-30 days
    59 59 118
        >30 days
    199 199 398
    Context of enrolment - Location
    Units: Subjects
        Clinic
    181 173 354
        Hospital
    87 96 183
    Context of enrolment - Consent giver
    Units: Subjects
        Proxy
    56 56 112
        Patient
    212 213 425
    History of intracranial or extracranial haemorrhage
    Units: Subjects
        Yes
    22 25 47
        No
    246 244 490
    Indication for antithrombotic therapy before intracerebral haemorrhage
    Full category name; > At least one occlusive vascular disease ----With atrial fibrillation ----Without atrial fibrillation >No occlusive vascular diseases ----With atrial fibrillation ----Without atrial fibrillation
    Units: Subjects
        Occlusive vascular disease (with AF)
    42 50 92
        Occlusive vascular disease (without AF)
    194 189 383
        No occlusive vascular disease (with AF)
    19 23 42
        No occlusive vascular disease (without AF)
    13 7 20
    Time since ICH symptom onset to randomisation in days (Overall)
    Units: day
        median (inter-quartile range (Q1-Q3))
    80.0 (29.5 to 148.5) 71.0 (29.0 to 144.0) -

    End points

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    End points reporting groups
    Reporting group title
    Start Antiplatelet
    Reporting group description
    The intervention of starting antiplatelet therapy was restricted to the use of one or more of oral aspirin, dipyridamole, or clopidogrel, begun within 24 h of randomisation with doses determined at the discretion of the consultant responsible for the participant.

    Reporting group title
    Avoid Antiplatelet
    Reporting group description
    The comparator was a policy of avoiding antiplatelet therapy. Participants were permitted to start or discontinue antiplatelet or anticoagulant therapy if clinically indicated by events during follow-up, regardless of treatment allocation.

    Primary: Recurrent symptomatic spontaneous intracerebral haemorrhage

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    End point title
    Recurrent symptomatic spontaneous intracerebral haemorrhage
    End point description
    End point type
    Primary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    12
    23
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Comparison groups
    Start Antiplatelet v Avoid Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.06
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.25
         upper limit
    1.03
    Notes
    [1] - Adjusted for minimisation variables: Qualifying ICH location of lobar versus non-lobar; Time since ICH symptom onset of 0-6 days versus 7-30 days versus over 30 days; Antiplatelet drug(s) that the patient’s clinician would start if allocated to aspirin alone versus any other regimen; Participant’s age at randomisation of less than 70 years versus 70 years or older; Predicted probability of a good six month outcome of less than 0.15 versus 0.15 or greater.

    Secondary: All major haemorrhagic events (all types of symptomatic spontaneous or traumatic intracranial haemorrhage, or symptomatic major extracranial haemorrhage)

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    End point title
    All major haemorrhagic events (all types of symptomatic spontaneous or traumatic intracranial haemorrhage, or symptomatic major extracranial haemorrhage)
    End point description
    End point type
    Secondary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    18
    25
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Comparison groups
    Start Antiplatelet v Avoid Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    P-value
    = 0.27
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.39
         upper limit
    1.3
    Notes
    [2] - Adjusted for minimisation variables: Qualifying ICH location of lobar versus non-lobar; Time since ICH symptom onset of 0-6 days versus 7-30 days versus over 30 days; Antiplatelet drug(s) that the patient’s clinician would start if allocated to aspirin alone versus any other regimen; Participant’s age at randomisation of less than 70 years versus 70 years or older; Predicted probability of a good six month outcome of less than 0.15 versus 0.15 or greater.

    Secondary: All major occlusive vascular events (ischaemic stroke; myocardial infarction; mesenteric ischaemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; or carotid, coronary, or peripheral arterial revascularisation procedures)

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    End point title
    All major occlusive vascular events (ischaemic stroke; myocardial infarction; mesenteric ischaemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; or carotid, coronary, or peripheral arterial revascularisation procedures)
    End point description
    End point type
    Secondary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    39
    38
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Comparison groups
    Avoid Antiplatelet v Start Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    = 0.92
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    1.6
    Notes
    [3] - Adjusted for minimisation variables: Qualifying ICH location of lobar versus non-lobar; Time since ICH symptom onset of 0-6 days versus 7-30 days versus over 30 days; Antiplatelet drug(s) that the patient’s clinician would start if allocated to aspirin alone versus any other regimen; Participant’s age at randomisation of less than 70 years versus 70 years or older; Predicted probability of a good six month outcome of less than 0.15 versus 0.15 or greater.

    Secondary: All major haemorrhagic or occlusive vascular events

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    End point title
    All major haemorrhagic or occlusive vascular events
    End point description
    End point type
    Secondary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    54
    61
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Comparison groups
    Start Antiplatelet v Avoid Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.43
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    1.24
    Notes
    [4] - Adjusted for minimisation variables: Qualifying ICH location of lobar versus non-lobar; Time since ICH symptom onset of 0-6 days versus 7-30 days versus over 30 days; Antiplatelet drug(s) that the patient’s clinician would start if allocated to aspirin alone versus any other regimen; Participant’s age at randomisation of less than 70 years versus 70 years or older; Predicted probability of a good six month outcome of less than 0.15 versus 0.15 or greater.

    Secondary: Major occlusive vascular events

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    End point title
    Major occlusive vascular events
    End point description
    End point type
    Secondary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    45
    52
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Comparison groups
    Start Antiplatelet v Avoid Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.39
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.56
         upper limit
    1.25

    Secondary: Major vascular events (as defined by the Antithrombotic Trialists’ Collaboration)

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    End point title
    Major vascular events (as defined by the Antithrombotic Trialists’ Collaboration)
    End point description
    End point type
    Secondary
    End point timeframe
    First event after randomisation and before death or most recent follow up.
    End point values
    Start Antiplatelet Avoid Antiplatelet
    Number of subjects analysed
    268
    268
    Units: Events
    45
    65
    Statistical analysis title
    Adjusted Cox proportional hazards regression
    Statistical analysis description
    Adjusted for minimisation variables: Qualifying ICH location of lobar versus non-lobar; Time since ICH symptom onset of 0-6 days versus 7-30 days versus over 30 days; Antiplatelet drug(s) that the patient’s clinician would start if allocated to aspirin alone versus any other regimen; Participant’s age at randomisation of less than 70 years versus 70 years or older; Predicted probability of a good six month outcome of less than 0.15 versus 0.15 or greater.
    Comparison groups
    Start Antiplatelet v Avoid Antiplatelet
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.025
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    0.95

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events in the RESTART trial were collected for all participants from the period between randomisation and the end of the trial (unless they withdrew).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Start Antiplatelet
    Reporting group description
    The intervention of starting antiplatelet therapy was restricted to the use of one or more of oral aspirin, dipyridamole, or clopidogrel, begun within 24 h of randomisation with doses determined at the discretion of the consultant responsible for the participant.

    Reporting group title
    Avoid Antiplatelet
    Reporting group description
    The comparator was a policy of avoiding antiplatelet therapy. Participants were permitted to start or discontinue antiplatelet or anticoagulant therapy if clinically indicated by events during follow-up, regardless of treatment allocation.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Section 12.5 of the protocol states, "...safety assessments in RESTART are focussed on detecting: primary and secondary outcomes (all of which relate to the safety of antiplatelet drugs in this patient group) and any SAEs and SUSARs... PIs need not report to the TCC or sponsor any non-fatal AEs that are neither primary/secondary trial outcomes nor SAEs nor SUSARs, and which are expected complications of ICH."
    Serious adverse events
    Start Antiplatelet Avoid Antiplatelet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 268 (1.87%)
    5 / 269 (1.86%)
         number of deaths (all causes)
    54
    50
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Colitis
    Additional description: admitted following flexisigmoidoscopy with severe colitis and pain
         subjects affected / exposed
    0 / 268 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Strangulated hernia repair
    Additional description: admitted for repair of strangulated paraumbilical hernia
         subjects affected / exposed
    1 / 268 (0.37%)
    0 / 269 (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 failure congestive
    Additional description: Patient admitted with with shortness of breath - suspected mild pulmonary oedema and small pleural effusions. Diagnosed with congested cardiac failure .
         subjects affected / exposed
    1 / 268 (0.37%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
    Additional description: syncopal episode after bowel prep for colonoscopy for change in bowel habit. Needed Mg replacement
         subjects affected / exposed
    1 / 268 (0.37%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
    Additional description: Admitted with vomiting, meleana and haematuria. Investigations highly suggestive of metastic prostate carcinoma.
         subjects affected / exposed
    0 / 268 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Postictal paralysis
    Additional description: Admitted with right arm shaking,slurred speech was being treated as ischaemic stroke initially and started on Aspirin 300mg,MR scan later ruled out ischaemic stroke and is now thought to be Todds Paresis
         subjects affected / exposed
    0 / 268 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hydrocholecystis
    Additional description: cholecystis
         subjects affected / exposed
    0 / 268 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pelvic fracture
    Additional description: fractured pubic rami
         subjects affected / exposed
    0 / 268 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    Additional description: Fractured L neck of femur following fall . Patient has had L dynamic hip screw
         subjects affected / exposed
    1 / 268 (0.37%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Start Antiplatelet Avoid Antiplatelet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 268 (0.00%)
    0 / 269 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2013
    AM01 Updated documents; - Protocol v2.0 - Participant Consent form v2.0 - GPIL Letter v2.0 - Participant Annual Questionnaire v2.0 - Participant Prompt v2.0 - Participant Information Sheet v2.0 - Participant Legal Representative Consent form v2.0 - Regained Capacity Participant Information Sheet v2.0 - RIL Participant Information Sheet v2.0
    22 Apr 2013
    AM04 New sites
    03 Jul 2013
    AM07 New sites Changes PI
    11 Jul 2013
    AM05 New sites
    23 Jul 2013
    AM06 Updated documents; - GP event form v2.1 - GPIL Letter v4.0 - Participant Annual Questionnaire v4.0 - Participant consent form V3.0 - GP follow up letter and questionnaire V3.0 - Patient Information Leaflet V3.0 - Participant annual questionnaire V4.0 - PLR consent form V3.0 - Protocol V4.0 - RIL V3.0 - Recovered PIL
    31 Jan 2014
    AM10 New sites Changes PI
    11 Mar 2014
    AM11 New sites Changes PI
    23 Apr 2014
    AM13 Updated documents; - GP follow-up letter and questionnaire V4 - Participant annual questionnaire V5 - Protocol V5
    18 Jul 2014
    AM15 New sites Changes PI
    06 Dec 2014
    AM09 New sites Changes PI
    14 Jan 2015
    AM16 Changes PI
    16 Apr 2015
    AM18 Updated documents; - RESTART consultant invitation letter to patient V1.2 - RESTART GP invitation letter to patient V1.2 - Protocol V6
    19 Jun 2015
    AM19 Changes PI
    23 Oct 2015
    AM20 Changes PI
    28 Jan 2016
    AM23 Changes PI
    05 Feb 2016
    AM21 Updated documents; - Participant consent form V4.0 - Participant consent form [Participant Consent Form] V4.0 - Participant consent form [Personal Legal Representative] V4.0 - Participant information sheet [PIS ] V4.0 - Participant information sheet [Relative IF] V4.0 - Participant information sheet [Recovered] V4.0
    27 Jun 2016
    AM25 Changes PI
    07 Oct 2016
    AM26 Changes of PI
    11 Jan 2017
    AM27 Changes of PI's
    05 Apr 2017
    AM28 (REC reference AM29) New site Change of PI
    28 Jun 2017
    AM29 (REC reference AM30) Change of PI
    05 Sep 2017
    AM30 (REC reference AM32) Change of PI
    13 Oct 2017
    AM31 (REC reference AM31) Updated documents - Summary of Characteristics booklet v1.0 - Protocol Version v8.0
    24 Apr 2019
    AM34 Change to SmPCs for Dipyridamole and Clopidogrel

    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.
    The main limitation of the trial was that it did not achieve its intended sample size.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29282142
    http://www.ncbi.nlm.nih.gov/pubmed/31129065
    http://www.ncbi.nlm.nih.gov/pubmed/28381307
    http://www.ncbi.nlm.nih.gov/pubmed/28253897
    http://www.ncbi.nlm.nih.gov/pubmed/28245843
    http://www.ncbi.nlm.nih.gov/pubmed/30909946
    http://www.ncbi.nlm.nih.gov/pubmed/31128924
    http://www.ncbi.nlm.nih.gov/pubmed/29506580
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