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    Clinical Trial Results:
    Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.

    Summary
    EudraCT number
    2011-000783-98
    Trial protocol
    IT  
    Global end of trial date
    13 Aug 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL2-16257-095
    Additional study identifiers
    ISRCTN number
    ISRCTN90566768
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France, 92284
    Public contact
    Innovation Therapeutic Pole, Institut de Recherches Internationales Servier, +33 155724366, clinicaltrials@servier.com
    Scientific contact
    Innovation Therapeutic Pole, Institut de Recherches Internationales Servier, +33 155724366, clinicaltrials@servier.com
    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
    13 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of Ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia
    Protection of trial subjects
    The study treatment could be prematurely discontinued if it was not tolerated, no longer appropriate or considered as contra-indicated. For the sake of safety, only patients presenting with a positive exercise at moderate or high workload were selected in the study, thus patients with low-effort inducible ischemia were not included.
    Background therapy
    Previous cardiovascular medication were maintained except previous anti-angina treatments. Short acting nitrates were authorized during the study.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    27 Mar 2012
    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
    Italy: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    5
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was carried out under the supervision of Prof. P.G. Camici in a unique centre at Istituto Scientifico Universitario San Raffaele, Milan, Italy

    Pre-assignment
    Screening details
    Study population was male and female patients with proven Coronary Artery Disease, Left Ventricular Ejection Fraction ≥ 40%, sinus rhythm, resting heart rate ≥ 70 bpm and exercise-inducible myocardial ischaemia at moderate to high workload and subsequent stunning. 26 patients were screened; 25 patients pre-selected and 15 patients were included.

    Pre-assignment period milestones
    Number of subjects started
    26 [1]
    Number of subjects completed
    15

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    non compliance to selection criteria: 11
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 11 patients showed non-compliance to selection criteria
    Period 1
    Period 1 title
    Ivabradine (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    ivabradine
    Arm description
    ivabradine 7.5 mg
    Arm type
    test drug

    Investigational medicinal product name
    ivabradine 7.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet twice daily during meals

    Number of subjects in period 1
    ivabradine
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ivabradine
    Reporting group description
    -

    Reporting group values
    Ivabradine Total
    Number of subjects
    15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    5 5
        From 65-84 years
    10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.8 ± 7.4 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    15 15

    End points

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    End points reporting groups
    Reporting group title
    ivabradine
    Reporting group description
    ivabradine 7.5 mg

    Subject analysis set title
    Included Set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All included patients

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All included patients having received at least one study drug intake and having a strain value at baseline and at W2 visit, at each time point (at rest, at peak and at 3 minutes of recovery) for at least one segment showing exercise-inducible myocardial stunning at baseline.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All included patients having received at least one study drug intake.

    Primary: Post-ischaemic myocardial stunning

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    End point title
    Post-ischaemic myocardial stunning [1]
    End point description
    By using bi-dimensional echocardiography at rest and at peak of exercise and during the recovery phase, a strain value (%) was measured for 16 segments of the LV myocardial wall. The segments showing post-ischaemic myocardial stunning at baseline were assessed for efficacy results.
    End point type
    Primary
    End point timeframe
    The primary endpoint was the post-ischaemic myocardial stunning evaluating changes (%) in regional myocardial wall motion from rest to peak exercise and to recovery time points (3 min, 10 min, 20 min). Change from baseline to W2 was provided.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only descriptive analyses were done
    End point values
    Full Analysis Set
    Number of subjects analysed
    15
    Units: strain relative change from rest
    arithmetic mean (standard deviation)
        change from baseline at peak
    23.1 ± 16.3
        change from baseline at 3 min recovery
    20.1 ± 12.3
        change from baseline at 10 min recovery
    10.3 ± 13.9
        change from baseline at 20 min recovery
    2.2 ± 10.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All over the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    ivabradine
    Reporting group description
    -

    Serious adverse events
    ivabradine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    ivabradine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    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: Low number of patients receiving the study drug and short duration of the treatment period.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2012
    To extend the enrolment period by one year from October 2012 to October 2013. ­To update information on concomitant treatments and the list of adverse events for which specific information was requested and already collected, if any.
    11 Jul 2013
    ­To extent the enrolment period by ten months from October 2013 to August 2014 To clarify a study procedure regarding the blood sampling results to be checked by the investigator before the inclusion of the patient

    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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