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    Clinical Trial Results:
    Estrategias para mejorar la eficacia y seguridad del tratamiento con Simvastatina en la Fase Aguda del Ictus Isquémico: STARS trial. Improving Safety and Efficacy of Simvastatin Treatment for the Acute Phase of Ischemic Stroke: STARS trial.

    Summary
    EudraCT number
    		 2007-005868-26
    Trial protocol
    		 ES  
    Global end of trial date
    10 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2021
    First version publication date
    20 Oct 2021
    Other versions
    Summary report(s)
    		 Stroke2016 Montaner

    Trial information

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    Trial identification
    Sponsor protocol code
    stars07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01073007
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Joan Montaner, VHIR, +34 932746766, joan.montaner@vhir.org
    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
    10 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demostrar que en la fase aguda del ictus isquémico el tratamiento con Simvastatina administrado en las primeras 12h del inicio de los síntomas mejora la situación neurológica y funcional del paciente valorado a los 7 días y tercer mes del inicio del tratamiento. [To demonstrate that in the acute phase of ischemic stroke, Simvastatin given within 12 hours of stroke onset improves neurological and functional status evaluated at day seven (or at discharge if this occurs before day 7) and at three months respectively].
    Protection of trial subjects
    Neurological deterioration (increase of the NIHSS ≥4 points) and major neurological improvement (NIHSS score of 0 or decrease in the NIHSS score, ≥8) were assessed at 7 days.
    Background therapy
    		 Intravenous tPA.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2008
    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: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    20
    From 65 to 84 years
    84
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 104
    Number of subjects completed
    		 104

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Simvastatin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Simvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg once daily for 90 days

    Number of subjects in period 1
    		Placebo Simvastatin
    Started
    54
    50
    Completed
    50
    48
    Not completed
    4
    2
         Lost to follow-up
    4
    2

    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
    		 104 104
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 84 84
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 74 (62.5 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 56 56

    End points

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

    Reporting group title
    Simvastatin
    Reporting group description
    		 -

    Subject analysis set title
    Complete treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Rankin Scale score

    Primary: Rankin scale

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    End point title
    		 Rankin scale
    End point description
    End point type
    Primary
    End point timeframe
    At the end of the treatment
    End point values
    		 Placebo Simvastatin
    Number of subjects analysed
    50
    48
    Units: unit(s)
    number (not applicable)
        Under 2
    35
    33
    Statistical analysis title
    		 Rankin scale
    Comparison groups
    Placebo v Simvastatin
    Number of subjects included in analysis
    98
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    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: All the reported adverse events were considered as serious. Non-serious events were not reported in the final publication (no additional data available)
    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 104 (11.54%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angor
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Malignant edema
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neurological deterioration
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Symptomatic intracerebral hemorrhage
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Meningitis
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    CRA branch occlusion
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory infection
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchial aspiration procedure
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 104 (0.00%)

    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.
    Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27758944
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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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