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    Clinical Trial Results:
    Ticagrelor and absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization

    Summary
    EudraCT number
    		 2013-002675-17
    Trial protocol
    		 ES  
    Global end of trial date
    15 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2021
    First version publication date
    03 May 2021
    Other versions
    Summary report(s)
    		 final results
    trial design
    main findings

    Trial information

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    Trial identification
    Sponsor protocol code
    TIGER-BVS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IDIBAPS
    Sponsor organisation address
    Carrer De Villaroel 170, Barcellona, Spain, 08036
    Public contact
    Servicio de Cardología, Hospital Clínic de Barcelona, 0034 9322754002042, sabrugal@clinic.ub.es
    Scientific contact
    Servicio de Cardología, Hospital Clínic de Barcelona, 0034 9322754002042, sabrugal@clinic.ub.es
    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
    21 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effects of ticagrelor vs. clopidogrel on the adenosine-induced physiological vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after percutaneous recanalization.
    Protection of trial subjects
    Subjects were strictly followed up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Regulatory reason, Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 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)
    78
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 screening was with few failed screening patients

    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
    		 clopidogrell
    Arm description
    		 -
    Arm type
    		 clopidogrel

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ticagrelor
    Arm description
    		 -
    Arm type
    		 ticagrelor

    Investigational medicinal product name
    ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Oral use
    Dosage and administration details
    loading dose of 180 mg, followed by 90 mg bid

    Number of subjects in period 1
    		clopidogrell ticagrelor
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    clopidogrell
    Reporting group description
    		 -

    Reporting group title
    ticagrelor
    Reporting group description
    		 -

    Primary: coronary blood flow

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    End point title
    		 coronary blood flow
    End point description
    End point type
    Primary
    End point timeframe
    baseline
    End point values
    		 clopidogrell ticagrelor
    Number of subjects analysed
    50
    50
    Units: AUC
        arithmetic mean (standard deviation)
    19604 ( 11244 )
    32122 ( 24039 )
    Statistical analysis title
    		 main endpoint analysis
    Comparison groups
    clopidogrell v ticagrelor
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 AUC
    Point estimate
    10000
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1000
         upper limit
    		 20000
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.0
    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: events were less than 1%

    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
    For support, Contact us.
    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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