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    Clinical Trial Results:
    A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrome patients undergoing coronary stenting

    Summary
    EudraCT number
    2013-001636-22
    Trial protocol
    DE   HU   AT   PL  
    Global end of trial date
    15 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Jul 2018
    First version publication date
    27 Jul 2018
    Other versions
    Summary report(s)
    Clinical Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    TROPICALACS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01959451
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Hospital of the University of Munich, Grosshadern
    Sponsor organisation address
    Marchioninistr.15, Munich, Germany,
    Public contact
    I. Med. Klinik und Poliklinik, Hospital of the University of Munich, Grosshadern, +49 89440072371,
    Scientific contact
    I. Med. Klinik und Poliklinik, Hospital of the University of Munich, Grosshadern, +49 89440072371,
    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
    08 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A Platelet function testing guided approach with a short-term (1 week) post hospital discharge prasugrel maintenance dose treatment and a switch-over to clopidogrel treatment in adequate responders to the drug is non-inferior to the currently recommended long-term (12 month) treatment with prasugrel in ACS patients undergoing PCI.
    Protection of trial subjects
    Every subject participating in the trial was insured against any trial-related illness/injuries pursuant to the legal requirements which may occur during the trial. Name of Insurer: HDI-Gerling Industrieversicherung AG Insurance Number: 39 130537 03026 Address: Niederlassung Düsseldorf Am Schönenkamp 45, D-40599 Düsseldorf Phone: +49 (0)211/7482-5419 Fax: +49 (0)211/7482-465 This insurance covered trial related injuries to health up to a maximum of 500.000 Euro per subject.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 72
    Country: Number of subjects enrolled
    Germany: 1440
    Country: Number of subjects enrolled
    Hungary: 878
    Country: Number of subjects enrolled
    Poland: 220
    Worldwide total number of subjects
    2610
    EEA total number of subjects
    2610
    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)
    1821
    From 65 to 84 years
    789
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    see document attached

    Pre-assignment
    Screening details
    Patients with an ACS (positive for troponin) after successful percutaneous coronary intervention with an indication for standard treatment of 12 month with prasugrel.

    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
    Guided de-escalation
    Arm description
    Guided de-escalation of DAPT
    Arm type
    Experimental

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    p.o.

    Arm title
    Control
    Arm description
    control group
    Arm type
    Placebo

    Investigational medicinal product name
    Prasugrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    p.o.

    Number of subjects in period 1
    Guided de-escalation Control
    Started
    1304
    1306
    Completed
    1304
    1306

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Guided de-escalation
    Reporting group description
    Guided de-escalation of DAPT

    Reporting group title
    Control
    Reporting group description
    control group

    Primary: primary endpoint

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    End point title
    primary endpoint
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    Guided de-escalation Control
    Number of subjects analysed
    1304
    1306
    Units: numbers
    95
    118
    Statistical analysis title
    kaplan meier
    Statistical analysis description
    ´Kaplan meier
    Comparison groups
    Guided de-escalation v Control
    Number of subjects included in analysis
    2610
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.05
    Method
    Fisher exact
    Confidence interval
    Notes
    [1] - non-inferiority

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    within 24 hours
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16-20.1
    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: please see document attached

    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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