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    Clinical Trial Results:
    Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation: a randomized controlled trial at the emergency department

    Summary
    EudraCT number
    		 2011-000695-34
    Trial protocol
    		 AT  
    Global end of trial date
    12 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2020
    First version publication date
    06 May 2020
    Other versions
    Summary report(s)
    		 Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation

    Trial information

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    Trial identification
    Sponsor protocol code
    Verna-Ibu-AF_1.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01447862
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Waehringer Guertel 18 - 20, Vienna, Austria, 1090
    Public contact
    Alexander Spiel, Medical University of Vienna, Department of Emergency Medicine, +43 1404003953, alexander.spiel@meduniwien.ac.at
    Scientific contact
    Alexander Spiel, Medical University of Vienna, Department of Emergency Medicine, +43 1404003953, alexander.spiel@meduniwien.ac.at
    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
    12 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.
    Protection of trial subjects
    According to data from the literature, vernakalant and ibutilide will lead to a cardioversion rate of approximately 50% in our study subjects. As we are aware of possible side effects of both ibutilide (especially ventricular arrhythmias/tachycardias, bundle branch blocks, atrioventricular blocks) and vernakalant (especially hypotension, bradycardia, dizziness, dysgeusia, sneezing, coughing) we will minimize the risk for side effects by appropriate exclusion criteria, by close monitoring (continuous saturation and ECG, blood pressure) of all participants and by providing all measures for adverse event management. Altogether, we assume a positive benefit/risk ratio.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2011
    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
    Austria: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    59
    From 65 to 84 years
    40
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 101 patients who have been admitted to the Emergency Department because of recent-onset atrial fibrillation (< 48h) have been recruited.

    Pre-assignment
    Screening details
    		 All patients, presenting to the emergency departement with symptoms of atrial fibrillation since no longer than 48 hours have been screened for potential enrollment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibutilide
    Arm description
    		 Ibutilide has been used as an active comparator to Vernakalant
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Corvert
    Investigational medicinal product code
    Other name
    Ibutilide
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will be given 1mg of ibutilide in 100ml normal saline intravenously over 10min. If atrial fibrillation continues after another 10 minutes of observation, patients will receive a second infusion of 1mg ibutilide, again over 10min. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.

    Arm title
    		 Vernakalant
    Arm description
    		 Vernakalant has been used as the drug to be investigated, compared to ibutilide.
    Arm type
    		 Drug to be investigated

    Investigational medicinal product name
    Brinavess
    Investigational medicinal product code
    Other name
    Vernakalant
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Initially, patients will be given 3mg/kg Vernakalant in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of Vernakalant (2mg/kg), again over 10 minutes. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.

    Number of subjects in period 1
    		Ibutilide Vernakalant
    Started
    51
    49
    Completed
    50
    49
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 100 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        18-99
    		 100 100
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.5 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 32
        Male
    		 68 68
    Subject analysis sets

    Subject analysis set title
    Vernakalant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received Vernakalant

    Subject analysis set title
    Ibutilide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects receiving Ibutilide

    Subject analysis sets values
    		 Vernakalant Ibutilide
    Number of subjects
    49
    51
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        18-99
    49
    51
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.2 ( 14.32 )
    56.7 ( 15.77 )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Ibutilide
    Reporting group description
    		 Ibutilide has been used as an active comparator to Vernakalant

    Reporting group title
    Vernakalant
    Reporting group description
    		 Vernakalant has been used as the drug to be investigated, compared to ibutilide.

    Subject analysis set title
    Vernakalant
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients received Vernakalant

    Subject analysis set title
    Ibutilide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects receiving Ibutilide

    Primary: Time in minutes conversion to sinus rhythm

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    End point title
    		 Time in minutes conversion to sinus rhythm
    End point description
    End point type
    Primary
    End point timeframe
    1 to 240 minutes
    End point values
    		 Ibutilide Vernakalant
    Number of subjects analysed
    51
    49
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    26 (9 to 55)
    10 (6 to 17)
    Statistical analysis title
    		 Primary endpoint statistic
    Comparison groups
    Ibutilide v Vernakalant
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time during hospital stay
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Ibutilide
    Reporting group description
    		 Patients treated with ibutilide

    Reporting group title
    Vernakalant
    Reporting group description
    		 Patients treated with vernakalant

    Serious adverse events
    		 Ibutilide Vernakalant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ibutilide Vernakalant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 51 (35.29%)
    13 / 49 (26.53%)
    General disorders and administration site conditions
    Arrhythmia
         subjects affected / exposed
    16 / 51 (31.37%)
    7 / 49 (14.29%)
         occurrences all number
    24
    7
    Sensational abnormalities
         subjects affected / exposed
    2 / 51 (3.92%)
    7 / 49 (14.29%)
         occurrences all number
    2
    14

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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