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    Clinical Trial Results:
    Assessment of Active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) plasma kinetics in Patients at acute stage of Ischemic Stroke: Prospective, Multicentre, Open, Non-randomised, Biomarker Study

    Summary
    EudraCT number
    		 2017-002760-41
    Trial protocol
    		 ES  
    Global end of trial date
    05 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2019
    First version publication date
    13 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL2-RTCCAR-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier (I.R.I.S)
    Sponsor organisation address
    50 rue Carnot, Suresnes Cedex, France, 92284
    Public contact
    Dr Benoît Tyl, Center for Therapeutic Innovation (CTI), Institut de Recherches Internationales Servier , +33 155724366, clinicaltrials@servier.com
    Scientific contact
    Dr Benoît Tyl, Center for Therapeutic Innovation (CTI), Institut de Recherches Internationales Servier, +33 155724366, clinicaltrials@servier.com
    Sponsor organisation name
    Laboratorios Servier S.L
    Sponsor organisation address
    Avenida de los Madroños, 33, Madrid, Spain,
    Public contact
    Mrs Itziar Fernandez Gonzalez, Dpto. de Investigacion y Desarrollo, , Laboratorios Servier S.L, +34 917489014, itziar.fernadezgonzalez@servier.com
    Scientific contact
    Mrs Itziar Fernandez Gonzalez, Dpto. de Investigacion y Desarrollo, , Laboratorios Servier S.L, +34 917489014, itziar.fernandezgonzalez@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
    05 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary exploratory objective of this trial was to assess the systemic plasma kinetics of the active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) during the acute stage of ischemic stroke in patients eligible for recombinant tissue Plasminogen Activator (rtPA) thrombolysis alone or rtPA thrombolysis followed by endovascular thrombectomy (EVT).
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arrange access to appropriate care for the patient.
    Background therapy
    		 No Investigational Medicinal Product (IMP) was provided to the patients. The patients received the standard-of-care treatment, including rtPA thrombolysis or rtPA thrombolysis and endovasular thrombectomy if indicated according to current clinical guidelines.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2017
    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
    Spain: 35
    Country: Number of subjects enrolled
    France: 2
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    7
    From 65 to 84 years
    17
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients ≥ 18 years old within 4.5 hours after ischemic stroke symptoms onset, with imaging evidence of cerebral artery occlusion in anterior circulation, and eligible for pharmacological thrombolysis alone or followed by EVT according to current clinical guidelines.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A (rtPA)
    Arm description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA (i.e. thrombolysis) alone according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.
    Arm type
    		 rtPA alone

    Investigational medicinal product name
    rtPA as background treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended dose of alteplase was 0.9 mg/kg over 60 minutes as indicated in the approved SmPC

    Arm title
    		 group B (rtPA+EVT)
    Arm description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA + EVT (i.e. thrombolysis + endovascular thrombectomy) according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.
    Arm type
    		 rtPA + Endovascular thrombectomy

    Investigational medicinal product name
    rtPA as background treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended dose of alteplase was 0.9 mg/kg over 60 minutes as indicated in the approved SmPC

    Number of subjects in period 1
    		Group A (rtPA) group B (rtPA+EVT)
    Started
    20
    17
    Completed
    19
    17
    Not completed
    1
    0
         Adverse event, serious fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A (rtPA)
    Reporting group description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA (i.e. thrombolysis) alone according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.

    Reporting group title
    group B (rtPA+EVT)
    Reporting group description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA + EVT (i.e. thrombolysis + endovascular thrombectomy) according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.

    Reporting group values
    		 Group A (rtPA) group B (rtPA+EVT) Total
    Number of subjects
    		 20 17 37
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 4 7
        From 65-84 years
    		 8 9 17
        85 years and over
    		 9 4 13
    Gender categorical
    Units: Subjects
        Female
    		 7 10 17
        Male
    		 13 7 20
    Subject analysis sets

    Subject analysis set title
    Included Set (IS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All enrolled patients included in the study

    Subject analysis set title
    Biomarker Set (BMKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients included in the study with a rtPA full dose administered

    Subject analysis sets values
    		 Included Set (IS) Biomarker Set (BMKS)
    Number of subjects
    37
    36
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    7
    6
        From 65-84 years
    17
    17
        85 years and over
    13
    13
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    17
    17
        Male
    20
    19

    End points

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    End points reporting groups
    Reporting group title
    Group A (rtPA)
    Reporting group description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA (i.e. thrombolysis) alone according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.

    Reporting group title
    group B (rtPA+EVT)
    Reporting group description
    		 No IMP is used in this study. Adult patients at acute stage of ischemic stroke eligible for rtPA + EVT (i.e. thrombolysis + endovascular thrombectomy) according to current clinical guidelines and investigator, and having documented cerebral artery occlusion in anterior circulation.

    Subject analysis set title
    Included Set (IS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All enrolled patients included in the study

    Subject analysis set title
    Biomarker Set (BMKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients included in the study with a rtPA full dose administered

    Primary: systemic TAFIa plasma level assessment

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    End point title
    		 systemic TAFIa plasma level assessment [1]
    End point description
    The primary endpoint was the systemic TAFIa plasma level
    End point type
    Primary
    End point timeframe
    Groups A and B : intravenous blood samples at baseline and at intervals over 24h since rtPA thrombolysis start Group B only : one arterial blood sample through the EVT catheter immediately before first pass.
    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: Within group comparisons versus baseline were specified but were not relevant due to the small sample size and the large inter-individual variability in TAFIa activity. A between group comparison on the change between baseline and T1h was specified in the statistical analysis plan but was not relevant for the same reasons.
    End point values
    		 Group A (rtPA) group B (rtPA+EVT)
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: U/L
        number (not applicable)
    Notes
    [2] - it was not possible to interpret inferential statistics due to a few number of biomarkers data
    [3] - It was not possible to interpret inferential statistics due to a few number of biomarkers data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    -from the signature of the informed consent up to the participant’s last study visit for all adverse events. -irrespective of the time of onset after the end of the study in case of serious adverse events related to ­the research.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Group rtPA
    Reporting group description
    		 Adult patients at acute stage of ischemic stroke eligible for rtPA (i.e. thrombolysis) alone according to current clinical guidelines, and having documented cerebral artery occlusion in anterior circulation.

    Reporting group title
    Group rtPA + EVT
    Reporting group description
    		 Adult patients at acute stage of ischemic stroke eligible for rtPA + EVT (i.e. thrombolysis + endovascular thrombectomy) according to current clinical guidelines, and having documented cerebral artery occlusion in anterior circulation.

    Serious adverse events
    		 Group rtPA Group rtPA + EVT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 17 (23.53%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonic epilepsy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group rtPA Group rtPA + EVT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    3 / 17 (17.65%)
    Investigations
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Aspiration
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0

    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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