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    Clinical Trial Results:
    Biomarkers and antithrombotic treatment in cervical artery dissection (TREAT-CAD)

    Summary
    EudraCT number
    		 2015-003200-23
    Trial protocol
    		 DE   DK  
    Global end of trial date
    21 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013DR3084
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02046460
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Basel
    Sponsor organisation address
    Petersgraben 4, Basel , Switzerland, 4031
    Public contact
    Stefan Engelter, MD, PI TREA-CAD, University Hospital Basel, stefan.engelter@usb.ch
    Scientific contact
    Stefan Engelter, MD, PI TREA-CAD, University Hospital Basel, stefan.engelter@usb.ch
    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
    22 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of acetylsalicylic acid (ASA) to anti-coagulant treatment (vitamin K antagonists) in patients with cervical artery dissection (CAD) with regard to outcome and complication measures
    Protection of trial subjects
    Implementation of data safety monitoring by a data safety monitoring board. Continuous monitoring for adverse and serious adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 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
    Denmark: 7
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Switzerland: 170
    Worldwide total number of subjects
    194
    EEA total number of subjects
    24
    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)
    188
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between Sept 11, 2013, and Dec 21, 2018, we enrolled 194 patients; 100 (52%) were randomly assigned to the aspirin group and 94 (48%) to the vitamin K antagonist group (78 received phenprocoumon, 12 acenocoumarol, and four warfarin).

    Pre-assignment
    Screening details
    		 Patients were screened according to the eligibility criteria for participation in the trial. At screening visit, written informed consent, patient history were obtained and physical examination including the assessment of the NIHSS score was performed.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    We did a randomised, open-label, multicentre, noninferiority trial with blinded assessment of outcome events.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aspirin
    Arm description
    		 Aspirin 300mg/d for 90d
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aspirin 300mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg/d

    Arm title
    		 Vitamin K Antagonists
    Arm description
    		 Phenprocoumon, Acenocoumarol or Warfarin with or without bridging with heparin or low-molecular-weight heparin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vitamin K Antagonists (Warfarin, Acenocoumarol, Phenprocoumon)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Variable dose with target INR 2-3, oral

    Number of subjects in period 1
    		Aspirin Vitamin K Antagonists
    Started
    100
    94
    Completed
    100
    94

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aspirin
    Reporting group description
    		 Aspirin 300mg/d for 90d

    Reporting group title
    Vitamin K Antagonists
    Reporting group description
    		 Phenprocoumon, Acenocoumarol or Warfarin with or without bridging with heparin or low-molecular-weight heparin.

    Reporting group values
    		 Aspirin Vitamin K Antagonists Total
    Number of subjects
    		 100 94 194
    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)
    		 46.6 ( 10.6 ) 45.5 ( 11.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 38 33 71
        Male
    		 62 61 123

    End points

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    End points reporting groups
    Reporting group title
    Aspirin
    Reporting group description
    		 Aspirin 300mg/d for 90d

    Reporting group title
    Vitamin K Antagonists
    Reporting group description
    		 Phenprocoumon, Acenocoumarol or Warfarin with or without bridging with heparin or low-molecular-weight heparin.

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol population

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    Composite of clinical (ischemic stroke, major extracranial hemorrhage, symptomatic intracranial hemorrhage, death) and MRI outcomes (new acute ischemic brain lesion, new hemorrhagic brain lesion)
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    		 Aspirin Vitamin K Antagonists Per protocol
    Number of subjects analysed
    100 [1]
    94 [2]
    173
    Units: Number
        Present
    22
    12
    33
        Absent
    78
    82
    140
    Notes
    [1] - Full analysis set
    [2] - Full analysis set
    Statistical analysis title
    		 Full analysis set
    Comparison groups
    Aspirin v Vitamin K Antagonists
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Overall there were 45 adverse events of which 7 were rated as serious.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2018
    Version 3.3

    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.
    Very rudimentary reporting of results - for full results please refer to the original publication of the trial results.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33765420
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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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