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    Clinical Trial Results:
    Anglo-Scandinavian Cardiac Outcomes Trial; Post Trial Follow-Up Study

    Summary
    EudraCT number
    2010-023875-24
    Trial protocol
    GB  
    Global end of trial date
    30 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Nov 2019
    First version publication date
    08 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRO1777
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01499511
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Judith A Mackay, Imperial College London, +44 2075941395, judith.mackay@imperial.nhs.uk
    Scientific contact
    Judith A Mackay, Imperial College London, +44 2075941395, judith.mackay@imperial.nhs.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 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research objective is to see whether there are long-term differences between the study treatments used in the original ASCOT study (atenolol-based vs perindopril-based treatment on blood pressure lowering, and atorvastatin versus placebo treatment on cholesterol lowering) in terms of cardiovascular disease (heart attacks, strokes and death from cardiovascular disease). Followup study without treatment
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Jan 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Scientific research
    Long term follow-up duration
    16 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1718
    Worldwide total number of subjects
    1718
    EEA total number of subjects
    1718
    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)
    173
    From 65 to 84 years
    1417
    85 years and over
    128

    Subject disposition

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    Recruitment
    Recruitment details
    ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and 2005.

    Pre-assignment
    Screening details
    It is follow up group from the ASCOT study, after 5.5 years treatment.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ASCOT participants amlodipine
    Arm description
    It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.
    Arm type
    no intervention

    Investigational medicinal product name
    No product
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    no intervention

    Arm title
    ASCOT Participants Atenolol
    Arm description
    It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Started
    885
    833
    Completed
    884
    833
    Not completed
    1
    0
         death
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASCOT participants amlodipine
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.

    Reporting group title
    ASCOT Participants Atenolol
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.

    Reporting group values
    ASCOT participants amlodipine ASCOT Participants Atenolol Total
    Number of subjects
    885 833 1718
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    85 88 173
        From 65-84 years
    731 686 1417
        more than 85 years
    69 59 128
    Age continuous
    Units: years
        median (full range (min-max))
    75 (53.97 to 92.54) 74.51 (52.36 to 91.03) -
    Gender categorical
    Units: Subjects
        Female
    739 720 1459
        Male
    146 113 259

    End points

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    End points reporting groups
    Reporting group title
    ASCOT participants amlodipine
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.

    Reporting group title
    ASCOT Participants Atenolol
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.

    Primary: Morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial_non fatal myocardial infarction

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    End point title
    Morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial_non fatal myocardial infarction
    End point description
    End point type
    Primary
    End point timeframe
    16 years
    End point values
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Number of subjects analysed
    877
    828
    Units: Participants
    35
    37
    Statistical analysis title
    non fatal myocardial infarction
    Comparison groups
    ASCOT participants amlodipine v ASCOT Participants Atenolol
    Number of subjects included in analysis
    1705
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.624
    Method
    ANOVA
    Parameter type
    Cox proportional hazard
    Confidence interval

    Primary: Morbidity After 16 Years in Patients Recruited Into the Anglo-Scandinavian Outcomes trial_non Fatal Stroke/TIA (Transient Ischaemic Attack)

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    End point title
    Morbidity After 16 Years in Patients Recruited Into the Anglo-Scandinavian Outcomes trial_non Fatal Stroke/TIA (Transient Ischaemic Attack)
    End point description
    End point type
    Primary
    End point timeframe
    16 years
    End point values
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Number of subjects analysed
    877
    823
    Units: Participants
    29
    52
    Statistical analysis title
    non Fatal Stroke/TIA (Transient Ischaemic Attack)
    Comparison groups
    ASCOT participants amlodipine v ASCOT Participants Atenolol
    Number of subjects included in analysis
    1700
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004
    Method
    ANOVA
    Confidence interval

    Secondary: Number of participants who have developed diabetes since the end of the ASCOT trial

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    End point title
    Number of participants who have developed diabetes since the end of the ASCOT trial
    End point description
    End point type
    Secondary
    End point timeframe
    16 years
    End point values
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Number of subjects analysed
    871
    825
    Units: Participants
    322
    325
    Statistical analysis title
    Diabetes
    Comparison groups
    ASCOT participants amlodipine v ASCOT Participants Atenolol
    Number of subjects included in analysis
    1696
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.304
    Method
    ANOVA
    Confidence interval

    Secondary: Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial

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    End point title
    Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial
    End point description
    End point type
    Secondary
    End point timeframe
    16 years
    End point values
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Number of subjects analysed
    872
    822
    Units: Participants
    39
    33
    Statistical analysis title
    Coronary/Peripheral Re-vascularisation Procedures
    Comparison groups
    ASCOT participants amlodipine v ASCOT Participants Atenolol
    Number of subjects included in analysis
    1694
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.641
    Method
    ANOVA
    Confidence interval

    Secondary: Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial

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    End point title
    Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial
    End point description
    End point type
    Secondary
    End point timeframe
    16 years
    End point values
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Number of subjects analysed
    874
    826
    Units: Participants
    10
    9
    Statistical analysis title
    Required Renal Replacement Therapy
    Comparison groups
    ASCOT participants amlodipine v ASCOT Participants Atenolol
    Number of subjects included in analysis
    1700
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.915
    Method
    ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 years follow up
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    ASCOT participants amlodipine
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with amlodipine for 5.5 years. No treatment only follow up.

    Reporting group title
    ASCOT Participants Atenolol
    Reporting group description
    It is follow up group from the ASCOT study, after treatment with atenolol for 5.5 years. No treatment only follow up.

    Serious adverse events
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 885 (0.23%)
    0 / 833 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Injuries
    Additional description: Cycling accident
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (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
    ASCOT participants amlodipine ASCOT Participants Atenolol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 885 (0.45%)
    1 / 833 (0.12%)
    Cardiac disorders
    High blood pressure
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Collapse
         subjects affected / exposed
    0 / 885 (0.00%)
    1 / 833 (0.12%)
         occurrences all number
    0
    0
    Alcohol dependence withdrawal
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Stomach cramp
         subjects affected / exposed
    1 / 885 (0.11%)
    0 / 833 (0.00%)
         occurrences all number
    1
    0

    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.
    None reported
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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