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    Clinical Trial Results:
    Eficacia de la colchicina administrada en el primer brote de pericarditis para evitar la aparición de recidivas.

    Summary
    EudraCT number
    		 2009-011258-16
    Trial protocol
    		 ES  
    Global end of trial date
    31 Dec 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    COLCHICINE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    Jaime Sagristà/Antonia Sambola, VHIR, asambola@vhebron.net
    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
    31 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study if administration of colchicine in the first episode of acute idiopathic pericarditis (AIP) is efficient to prevent recurrent episodes Estudiar si la colchicina administrada en el primer brote de una pericarditis aguda idiopática es eficaz para prevenir la aparición de recidivas.
    Protection of trial subjects
    Each visit was performed through a structured interview (questionnaire) where the occurrence of symptoms or signs of a possible new episode of pericarditis were recorded. During follow-up, testing of each visit included basic vital signs and a general physical examination. All patients received a proton pump inhibitor as gastroduodenal prophylaxis
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2004
    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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    110
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from February 2004 to May 2010 in 3 Spanish tertiary hospitals

    Pre-assignment
    Screening details
    		 The inclusion criteria were: a) AIP evident at the time of inclusion, and b) agreement to participate in the study with provision of informed consent.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Colchicine
    Arm description
    		 Conventional anti-inflammnatory tretament (Aspirin and/or Ibuprofen) plus colchicine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Colchicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Colchicine orally 1 mg/12 h for patients who weighed more than 70 kg, or 0.5 mg/12h in patients with a weight <70kg, for 3 months

    Investigational medicinal product name
    Aspirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Aspirine 1g every 6 or 8 hours, for 2 to 10 days with tapering over 3 to 4 weeks

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen orally 600 mg every 8hours, for 2 to 10 days with tapering over 3 to 4 weeks

    Investigational medicinal product name
    Indomethacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Indomethacin orally 50mg every 8hours for 2 to 10 days with tapering over 3 to 4 weeks

    Arm title
    		 Conventional treatment
    Arm description
    		 Conventional tertament of aspirin and NSAIDs
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aspirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Aspirine 1g every 6 or 8 hours, for 2 to 10 days with tapering over 3 to 4 weeks

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen orally 600 mg every 8hours, for 2 to 10 days with tapering over 3 to 4 weeks

    Investigational medicinal product name
    Indomethacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Indomethacin orally 50mg every 8hours for 2 to 10 days with tapering over 3 to 4 weeks

    Number of subjects in period 1
    		Colchicine Conventional treatment
    Started
    59
    51
    Completed
    57
    45
    Not completed
    2
    6
         Adverse event, serious fatal
    1
    2
         Lost to follow-up
    1
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Colchicine
    Reporting group description
    		 Conventional anti-inflammnatory tretament (Aspirin and/or Ibuprofen) plus colchicine

    Reporting group title
    Conventional treatment
    Reporting group description
    		 Conventional tertament of aspirin and NSAIDs

    Primary: Appearance of recurrent episodes

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    End point title
    		 Appearance of recurrent episodes
    End point description
    End point type
    Primary
    End point timeframe
    24 months of follow-up
    End point values
    		 Colchicine Conventional treatment
    Number of subjects analysed
    57
    45
    Units: percent
        number (not applicable)
    13.5
    7.8
    Statistical analysis title
    		 Recurrent pericarditis
    Comparison groups
    Colchicine v Conventional treatment
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.34
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Time to first recurrence

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    End point title
    		 Time to first recurrence
    End point description
    End point type
    Secondary
    End point timeframe
    24 months of follow-up
    End point values
    		 Colchicine Conventional treatment
    Number of subjects analysed
    59
    51
    Units: month
        arithmetic mean (standard deviation)
    9.6 ( 9.0 )
    8.3 ( 10.5 )
    Statistical analysis title
    		 Time to first recurrence
    Comparison groups
    Colchicine v Conventional treatment
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Episode duration

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    End point title
    		 Episode duration
    End point description
    End point type
    Secondary
    End point timeframe
    24 months of follow-up
    End point values
    		 Colchicine Conventional treatment
    Number of subjects analysed
    59
    51
    Units: day
        arithmetic mean (standard deviation)
    6.3 ( 2.9 )
    9.1 ( 3.4 )
    Statistical analysis title
    		 Episode duration
    Comparison groups
    Colchicine v Conventional treatment
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Colchicine
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Colchicine Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Colchicine Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 59 (13.56%)
    4 / 51 (7.84%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 59 (13.56%)
    0 / 51 (0.00%)
         occurrences all number
    8
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 59 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    4

    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.
    We only included patients with acute idiopathic/viral pericarditis. Patients with postcardiac injury pericarditis or pericarditis secondary to connective tissue disease were not included. Higher doses of colchicine were used than in previous trials

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30683494
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