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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Clinical Trial Results:
    EFFEKTEN AF EZETIMIBE SOM TILLÆG TIL OPTIMAL STATINBEHANDLING PÅ PLAQUE-KOMPOSITIONEN HOS PATIENTER MED AKUT MYOKARDIEINFARKT - VURDERET MED OPTICAL COHERENCE TOMOGRAPHY OG INTRAVASKULÆR ULTRALYD (OCTIVUS)

    Summary
    EudraCT number
    2010-022604-45
    Trial protocol
    DK  
    Global end of trial date
    20 Jun 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    25 Jun 2021
    First version publication date
    05 Jun 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Validation of the reported data has been requested.
    Summary report(s)
    OCTIVUS Thesis

    Trial information

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    Trial identification
    Sponsor protocol code
    46908990
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01385631
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Sdr. Boulevard 29, Odense C, Denmark, 5000
    Public contact
    Same as organisation, Dr. Henrik Steen Hansen Odense University Hospital, Department of Cardiology, 45 21955161, Henrik.Steen.Hansen@rsyd.dk
    Scientific contact
    Same as organisation, Dr. Henrik Steen Hansen Odense University Hospital, Department of Cardiology, 45 21955161, Henrik.Steen.Hansen@rsyd.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
    23 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether Ezetimibe 10 mg per day in addition to Atorvastin 80 mg per day results in further plaque regression and to assess changes in plaque composition.
    Protection of trial subjects
    Patients were followed with clinical evaluation and safety blood samples after 1, 3, and 6 months to assess possible adverse events and compliance.
    Background therapy
    Atorvastatin 80 mg per day
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Jun 2011
    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
    Denmark: 87
    Worldwide total number of subjects
    87
    EEA total number of subjects
    87
    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)
    64
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Eligible for recruitment were patients with first time ST segment myocardial infarction (STEMI) not previously treated with cholesterol lowering drugs. Patients were required to be >18 and <81 years and able to provide written consent. For further details see the attached thesis (pdf).

    Pre-assignment
    Screening details
    Main inclusion criteria was first time STEMI, and main exclusion criterias were ongoing lipid lowering therapy, age >80, concommittant disease and use of another drug eluting stent than the one designated by the study protocol (Resolute Integrity, St. Jude Medical).

    Pre-assignment period milestones
    Number of subjects started
    87
    Number of subjects completed
    87

    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, Monitor, Data analyst, Assessor
    Blinding implementation details
    Assignment to treatment arms was randomized by the hospital pharmacy and study medication was derived as blinded capsules. Patient data were achieved with randomized study-ID numbers associated with the patient-ID in a key-file not accessible to the investigator. The analyst was blinded for patient ID and baseline-follow-up sequence during assessment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention arm
    Arm description
    Patients assigned to the intervention arm were treated with atorvastatin 80 mg AND ezetimibe 10 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    ezetimibe
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg per day

    Investigational medicinal product name
    Aorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg per day

    Arm title
    Placebo
    Arm description
    Patients treated with atorvastin 80 mg AND placebo
    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
    N/A

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg per day

    Number of subjects in period 1
    Intervention arm Placebo
    Started
    43
    44
    Completed
    40
    42
    Not completed
    3
    2
         Diagnosed with cancer
    1
    -
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Intervention arm
    Reporting group description
    Patients assigned to the intervention arm were treated with atorvastatin 80 mg AND ezetimibe 10 mg.

    Reporting group title
    Placebo
    Reporting group description
    Patients treated with atorvastin 80 mg AND placebo

    Primary: Change in necrotic core

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    End point title
    Change in necrotic core
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    Intervention arm Placebo
    Number of subjects analysed
    39 [1]
    38 [2]
    Units: cubic millimeters
        median (inter-quartile range (Q1-Q3))
    -0.2 (-2.2 to 2.3)
    -0.3 (-2.7 to 2.6)
    Notes
    [1] - Change in most disesed 10 mm segment
    [2] - Change in 10 mm most diseased segment
    Statistical analysis title
    Change from baseline
    Comparison groups
    Intervention arm v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Annual safety report
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    SAE and AE
    Reporting group description
    -

    Serious adverse events
    SAE and AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 22 (77.27%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    coronary dissection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
    Additional description: Admission with suspicion of angina pectoris
         subjects affected / exposed
    8 / 22 (36.36%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Repeated revascularization
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    ICD implantation
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    c. pulm
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tonsil cancer
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 22 (4.55%)
         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
    SAE and AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 22 (22.73%)
    Vascular disorders
    Claudicatio
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Social circumstances
    compliance problem
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    1
    Hepatobiliary disorders
    Transaminases increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    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
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