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    Clinical Trial Results:
    Effect of ACE-Inhibition on Microvascular Function in Women with Assessed Microvascular Dysfunction and No Obstructive Coronary Artery Disease.

    Summary
    EudraCT number
    		 2014-004490-17
    Trial protocol
    		 DK  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2021
    First version publication date
    13 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    72
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02525081
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg University Hospital
    Sponsor organisation address
    ​Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    https://clinicaltrials.gov, Bispebjerg University Hospital, Eva.Irene.Bossano.Prescott@regionh.dk
    Scientific contact
    https://clinicaltrials.gov, Bispebjerg University Hospital, Eva.Irene.Bossano.Prescott@regionh.dk
    Sponsor organisation name
    Bispebjerg University Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen NV, Denmark, 2400
    Public contact
    Professor Eva Prescott, Department of Cardiology, Bispebjerg University Hospital, 0045 22572614, Eva.Irene.Bossano.Prescott@regionh.dk
    Scientific contact
    Professor Eva Prescott, Department of Cardiology, Bispebjerg University Hospital, 0045 22572614, Eva.Irene.Bossano.Prescott@regionh.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
    20 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to explore effects of long term treatment with ACE-inhibitor on the microvasculature assessed by coronary flow reserve by transthoracic echocardiography in normotensive patients with microvascular dysfunction (CFR<2.2) and Angina Pectoris but no coronary artery disease
    Protection of trial subjects
    Patients who where bother by potential side effects and did not want to continue in the study were able to withdraw from the study. If patients could not complete main examination (stress echocardiography with adenosine infusion) due to discomfort we stopped the infusion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    Denmark: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    42
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from July 2015 to December 2015

    Pre-assignment
    Screening details
    		 A total of 201 patients from the iPOWER cohort met inclusion and exclusion criteria. Further, 138 patients were excluded as per protocol. We included 63 patients. A total of 55 patients completed the study (ACE inhibitor group, 28, and placebo, 27).

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ramipril
    Arm description
    		 Interventional
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ramipril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Between 2.5 to 10 mg per day (up titrated according to systolic blood pressure )

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Between 2.5 to 10 mg per day (up titrated according to blood pressure)

    Number of subjects in period 1
    		Ramipril Placebo
    Started
    32
    31
    Completed
    28
    27
    Not completed
    4
    4
         Consent withdrawn by subject
    2
    4
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ramipril
    Reporting group description
    		 Interventional

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Ramipril Placebo Total
    Number of subjects
    		 32 31 63
    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)
    		 58.6 ± 11.6 57.3 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    		 32 31 63
        Male
    		 0 0 0
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 124.1 ± 11 127.4 ± 11 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 70.2 ± 7.7 67.2 ± 7.8 -
    Heart rate
    Units: beats/min
        arithmetic mean (standard deviation)
    		 65.9 ± 11.3 66.2 ± 10.1 -
    Subject analysis sets

    Subject analysis set title
    Baseline characteristic
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    unpaired t-test has been performed to evaluate division of baseline characteristic between groups

    Subject analysis sets values
    		 Baseline characteristic
    Number of subjects
    63
    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)
    57.9 ± 11.9
    Gender categorical
    Units: Subjects
        Female
    63
        Male
    0
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    125.7 ± 11
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    68.7 ± 7.9
    Heart rate
    Units: beats/min
        arithmetic mean (standard deviation)
    68.7 ± 7.9

    End points

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    End points reporting groups
    Reporting group title
    Ramipril
    Reporting group description
    		 Interventional

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Baseline characteristic
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    unpaired t-test has been performed to evaluate division of baseline characteristic between groups

    Primary: Change in coronary flow velocity reserve

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    End point title
    		 Change in coronary flow velocity reserve
    End point description
    Coronary flow velocity reserve is measured by dipyridamole induced stress transthoracic Doppler echocardiography, which assess coronary microvascular function
    End point type
    Primary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    32
    31
    Units: ratio
        arithmetic mean (confidence interval 95%)
    0.34 (0.11 to 0.56)
    0.26 (0.03 to 0.48)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [1] - No difference detected between interventional groups

    Secondary: Change in GLS at rest

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    End point title
    		 Change in GLS at rest
    End point description
    GLS: Global longitudinal strain
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    30
    31
    Units: percentage
        arithmetic mean (confidence interval 95%)
    -0.24 (-1.07 to 0.59)
    -0.03 (-0.85 to 0.79)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.71
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in GLS at hyperemia

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    End point title
    		 Change in GLS at hyperemia
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    26
    28
    Units: percentage
        arithmetic mean (confidence interval 95%)
    -0.17 (-1.06 to 0.72)
    -0.03 (-0.91 to 0.86)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Placebo v Ramipril
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [2] - No difference detected between interventional groups

    Secondary: Change in the GLS reserve

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    End point title
    		 Change in the GLS reserve
    End point description
    GLS: GLobal longtudinal strain
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    26
    28
    Units: percentage
        arithmetic mean (confidence interval 95%)
    -0.03 (-1.04 to 0.99)
    -0.07 (-1.07 to 0.93)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.94 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [3] - No difference detected between interventional groups

    Secondary: Change in left ventricular ejection fraction

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    End point title
    		 Change in left ventricular ejection fraction
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    32
    31
    Units: percentage
        arithmetic mean (confidence interval 95%)
    0.56 (-1.47 to 2.59)
    0.93 (-1.14 to 3)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.79 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [4] - No difference detected between interventional groups

    Secondary: Change in left ventricular mass index

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    End point title
    		 Change in left ventricular mass index
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    32
    31
    Units: g/m2
        arithmetic mean (confidence interval 95%)
    0.76 (-5.01 to 6.53)
    0.76 (-5.11 to 6.64)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Placebo v Ramipril
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [5] - No difference detected between interventional groups

    Secondary: Change in left atrial volume index

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    End point title
    		 Change in left atrial volume index
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    32
    31
    Units: mL/m2
        arithmetic mean (confidence interval 95%)
    1.49 (-0.8 to 3.79)
    1.44 (-0.89 to 3.78)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [6] - No difference detected between interventional groups

    Secondary: Change in deceleration time

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    End point title
    		 Change in deceleration time
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    28
    29
    Units: ms
        arithmetic mean (confidence interval 95%)
    -18.19 (-31.83 to -4.55)
    -9.53 (-22.97 to 3.9)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31 [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [7] - No difference detected between interventional groups

    Secondary: Change in E/A ratio

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    End point title
    		 Change in E/A ratio
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    28
    29
    Units: ratio
        arithmetic mean (confidence interval 95%)
    -0.04 (-0.1 to 0.02)
    -0.01 (-0.07 to 0.05)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.47 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [8] - No difference detected between interventional groups

    Secondary: Change in e'

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    End point title
    		 Change in e'
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    28
    29
    Units: cm/s
        arithmetic mean (confidence interval 95%)
    -0.09 (-0.63 to 0.46)
    0.14 (-0.41 to 0.7)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56 [9]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [9] - No difference detected between interventional groups

    Secondary: Change in E/e'

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    End point title
    		 Change in E/e'
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    28
    27
    Units: ratio
        arithmetic mean (confidence interval 95%)
    -0.22 (-0.75 to 0.32)
    -0.15 (-0.68 to 0.38)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Change in flow mediated dilation

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    End point title
    		 Change in flow mediated dilation
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    24
    24
    Units: percentage
        arithmetic mean (confidence interval 95%)
    0.4 (-1.81 to 2.61)
    0.77 (-1.5 to 3.03)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Placebo v Ramipril
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05 [10]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [10] - No difference detected between interventional groups

    Secondary: Change in nitroglycerine mediated dilation

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    End point title
    		 Change in nitroglycerine mediated dilation
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    23
    23
    Units: percentage
        arithmetic mean (confidence interval 95%)
    -2.21 (-5.94 to 1.52)
    -2.21 (-6.01 to 1.59)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Change in resting arterial diameter

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    End point title
    		 Change in resting arterial diameter
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    24
    24
    Units: mm
        arithmetic mean (confidence interval 95%)
    -0.2 (-0.35 to -0.06)
    -0.07 (-0.23 to 0.08)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2 [11]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [11] - No difference detected between interventional groups

    Secondary: Change in arterial diameter at peak hyperaemia

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    End point title
    		 Change in arterial diameter at peak hyperaemia
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    24
    24
    Units: mm
        arithmetic mean (confidence interval 95%)
    -0.2 (-0.36 to -0.03)
    -0.06 (-0.24 to 0.11)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.24 [12]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [12] - No difference detected between interventional groups

    Secondary: Change in shear rate area under the curve to peak

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    End point title
    		 Change in shear rate area under the curve to peak
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    24
    23
    Units: s-1/s
        arithmetic mean (confidence interval 95%)
    5049 (-58 to 10157)
    235 (-5100 to 5569)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Ramipril v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14 [13]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [13] - No difference detected between interventional groups

    Secondary: Change in physical limitation

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    End point title
    		 Change in physical limitation
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    31
    28
    Units: score
        arithmetic mean (confidence interval 95%)
    -0.36 (-5.99 to 5.28)
    3.74 (-1.85 to 9.33)
    Statistical analysis title
    		 Unstructured linear mixed model
    Statistical analysis description
    An unstructured linear mixed model (PROC MIXED in SAS) was used to perform baseline-adjusted analysis
    Comparison groups
    Placebo v Ramipril
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31 [14]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [14] - No difference detected between interventional groups

    Secondary: Change in angina stability

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    End point title
    		 Change in angina stability
    End point description
    End point type
    Secondary
    End point timeframe
    4-6 months
    End point values
    		 Ramipril Placebo
    Number of subjects analysed
    28
    27
    Units: score
        arithmetic mean (confidence interval 95%)
    15.39 (5.20 to 25.58)
    27.33 (17.37 to 37.29)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    29th of July 2015 to the 28th of April 2016.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No dictionary
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: A standard dictionary was not used for collection of adverse events and therefore the reporting does not fit into this reporting system. Overall, the proportion of participants experiencing an event categorized as either an adverse event, adverse reaction (common side effects) or serious adverse event was not significantly different between treatment groups: 20% vs. 18% (p = 0.74), 22% vs. 28% (p = 0.33) and 5% vs. 5% (p = 0.80), respectively.

    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
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