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    Clinical Trial Results:
    Statins for prevention of disease progression and hospitalization in Liver Cirrhosis: A multi-center, randomized, double blind, placebo-controlled trial. The STATLiver Trial.

    Summary
    EudraCT number
    		 2019-001806-40
    Trial protocol
    		 DK  
    Global end of trial date
    04 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    STATLiver2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04072601
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hvidovre University Hospital
    Sponsor organisation address
    Gastro Unit, 360, Kettegaard alle 30, Hvidovre, Denmark, 2650
    Public contact
    Nina Kimer , Afsnit 360, Gastroenheden, 0045 38621968, thit.mynster.kronborg@regionh.dk
    Scientific contact
    Nina Kimer , Afsnit 360, Gastroenheden, 0045 38621968, thit.mynster.kronborg@regionh.dk
    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
    04 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Add on treatment with atorvastatin 10-20 mg to standard treatment improves survival in patients with cirrhosis of any etiology. The second primary endpoint was hospitalisation rate.
    Protection of trial subjects
    All trial subjects were offered standard treatment following national guidelines. All trial subjects were monitored regarding safety end side effects to treatment. All patient data were anonymized.
    Background therapy
    		 Standard treatment with diuretics, antihypertensive medication and symptomatic care in case of complications.
    Evidence for comparator
    		 Placebo
    Actual start date of recruitment
    11 Nov 2019
    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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    51
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between February 2020 and December 2021, 78 participants were enrolled in the trial. Recruitment was hindered by Covid19, and lack of funding resources.

    Pre-assignment
    Screening details
    		 Patients with cirrhosis attending outpatient clinics and medcial wards in the Hospitals Hvidovre, Aarhus and Herlev were screened for eligibility

    Period 1
    Period 1 title
    Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Randomisation lists were produced by an external partner at the regional Pharmacy in Capital Region of Denmark. Participants were allocated to study medication based on these randomisation lists. All trial participants, study personnel, investigators and monitors were blinded. Six months data assessment on both clinical (primary, secondary and safety) and exploratory outcomes were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atorvastatin Group
    Arm description
    		 Trial participants received 10 mg atorvastatin (1 capsule) in addition to standard treatment. If the trial medication was tolerated the dose was increased to 20 mg (two capsules)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    C10AA05
    Other name
    Lipistad
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg (one capsule), increased to 20 mg (two capsules) daily, administered orally and taken at night time. Medication was delivered to the patient at baseline and every 3 months. Excess capsules were returned be the trial participant at each study visit

    Arm title
    		 Placebo group
    Arm description
    		 Trial participants received placebo capsules similar in colour, size and shape to the atorvastatin capsules
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule similar in shape, size and color to atorvastatin capsules, containing flavorless and colorless filler, were administered at night time. Dosage was regulated to two capsules if the trial medication was tolerated. Capsules were administered at baseline and every 3 months. Excess capsules were returned at study visits

    Number of subjects in period 1
    		Atorvastatin Group Placebo group
    Started
    38
    40
    Completed
    28
    31
    Not completed
    10
    9
         Adverse event, serious fatal
    3
    2
         Physician decision
    3
    3
         Consent withdrawn by subject
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study
    Reporting group description
    		 -

    Reporting group values
    		 Study Total
    Number of subjects
    		 78 78
    Age categorical
    Inclusion criteria were age 18 to 80 years of age.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 31 31
        85 years and over
    		 0 0
        All study paticipants
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60.5 (37 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 45 45

    End points

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    End points reporting groups
    Reporting group title
    Atorvastatin Group
    Reporting group description
    		 Trial participants received 10 mg atorvastatin (1 capsule) in addition to standard treatment. If the trial medication was tolerated the dose was increased to 20 mg (two capsules)

    Reporting group title
    Placebo group
    Reporting group description
    		 Trial participants received placebo capsules similar in colour, size and shape to the atorvastatin capsules

    Primary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Primary
    End point timeframe
    180 days
    End point values
    		 Atorvastatin Group Placebo group
    Number of subjects analysed
    38
    40
    Units: number
    3
    2
    Statistical analysis title
    		 Comparison of mortality
    Statistical analysis description
    Comparison of mortality in the two groups
    Comparison groups
    Atorvastatin Group v Placebo group
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Admissions

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    End point title
    		 Admissions
    End point description
    Number of hospital admissions within 180 days
    End point type
    Primary
    End point timeframe
    180 days
    End point values
    		 Atorvastatin Group Placebo group
    Number of subjects analysed
    38
    40
    Units: Number
        All admissions
    23
    22
        Liver-related admissions
    17
    13
    Statistical analysis title
    		 Comparision of admissions
    Statistical analysis description
    Comparison of the number of admissions in the two groups
    Comparison groups
    Atorvastatin Group v Placebo group
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.97
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From 0 to 547 days
    Adverse event reporting additional description
    Adverse events during trial period. Min. follow-up was 180 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Atorvastatin group
    Reporting group description
    		 Group exposed to Atorvastatin intervention

    Reporting group title
    Placebo group
    Reporting group description
    		 Patients exposed to placebo intervention

    Serious adverse events
    		 Atorvastatin group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 38 (39.47%)
    17 / 40 (42.50%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    3
    2
    Injury, poisoning and procedural complications
    Trauma, poisoning and procedures
         subjects affected / exposed
    4 / 38 (10.53%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Cardiac related events
    Additional description: Events due to cardiac events
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cramps
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Cancers
    Additional description: Events related to complications of cancer disease (cancer diagnosis established after inclusion).
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Social circumstances
    Death
    Additional description: Death outside of hospital, unknown causes and circumstances
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Changed general condition
    Additional description: Exhaustion, in general need for help, also from communal providers
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GI-related
    Additional description: Gastrointestinal events as nausea, vomiting, abdominal pain, intestinal and gastric lesions
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 40 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cirrhosis decompensations
    Additional description: Events incuding hepatorenal syndrome, ascites, edema, spontaneous bacterial peritonitis, electrolyte disturbances, esophageal varices , hepatic encephalopathy and alcoholic hepatitis
         subjects affected / exposed
    8 / 38 (21.05%)
    10 / 40 (25.00%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal and urinary disorders
    Kidney related
    Additional description: Kidney related, hepatorenal syndrome excluded
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric and alcohol abuse related
    Additional description: Admissions due to alcohol intoxication and/or psychiatric problems
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 40 (10.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections
    Additional description: Infections, not including spontaneous bacterial peritonitis
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atorvastatin group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 38 (28.95%)
    15 / 40 (37.50%)
    Injury, poisoning and procedural complications
    Injuries
    Additional description: Injuries in musculoskeletal system and joints including the scalp
         subjects affected / exposed
    4 / 38 (10.53%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    General disorders and administration site conditions
    Oropharyngeal symptoms
    Additional description: Tongue disease, dysphagia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Tremor and vertigo
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Eye disorders
    Symptoms from eyes
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Symptoms from GI tract
    Additional description: Includes cholecystitis, abdominal pain, obstipation, ascites
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 40 (10.00%)
         occurrences all number
    3
    5
    Respiratory, thoracic and mediastinal disorders
    Respiratory symptoms
    Additional description: Symptoms of cough and/or dyspnoea, and/or Covid-19
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Alcohol problem
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 40 (2.50%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Calculus of kidney
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Product issues
    Side effects
    Additional description: Creatine kinase affection or subjective adverse effects
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 40 (2.50%)
         occurrences all number
    1
    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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