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    Summary
    EudraCT Number:2013-000055-41
    Sponsor's Protocol Code Number:CV185220
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-000055-41
    A.3Full title of the trial
    Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
    A.3.2Name or abbreviated title of the trial where available
    AEGEAN
    A.4.1Sponsor's protocol code numberCV185220
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEu Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeBMS-562247-01
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeBMS-562247-01
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with diagnosed non-valvular atrial fibrillation or atrial flutter
    with at least one risk factor for stroke and indicated for oral
    anticoagulant.
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation or rapid atrial rythm with risk of stroke.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for SPAF at 24 weeks.
    E.2.2Secondary objectives of the trial
    - To identify predictive risk factors linked to non-adherence in patients treated with apixaban.
    - To compare implementation phase adherence to apixaban treatment with secondary SOC versus (1) primary SOC and (2) continued additional educational program.
    - To compare implementation phase adherence to apixaban treatment at 12 weeks vs 24 weeks within groups.
    - To evaluate impact of educational programme on safety profile of apixaban.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Written Informed Consent.
    - Patients with diagnosed non-valvular atrial fibrillation or atrial flutter
    (documented by 12-lead ECG or a Holter recording) and eligible for OAC
    therapy.
    - Presence of at least one of the following risk factors for stroke:
    prior stroke or transient ischaemic attack (TIA)
    age ≥75 years
    hypertension
    diabetes mellitus
    symptomatic heart failure (NYHA Class ≥ II)
    - Must be able to self-administer treatment.
    - Either VKA treated or VKA naive.
    VKA-treat patients must have received the VKA treatment for ≥3 months.
    VKA-naïve patients must not have received VKA treatment for more than
    30 days within the last 12 months.
    Patients who are not described by either of the above criteria (for
    example, a patient treated with VKA for 40 days within the last 12
    months) are not eligible for the study.
    - Patients previously treated with ASA for stroke prevention are allowed
    (and will switch to apixaban).
    - Patients with screening Mini-mental state examination score (MMSE)
    more than 24 (out of 30).
    - Patient Re-enrollment: This study does not permit the re-enrollment of
    a patient that has discontinued the study as a pre-treatment failure.
    - Men and women ≥ 18 years of age.
    - Women of childbearing potential (WOCBP) must use method(s) of
    contraception based on the tables in Appendix 3.
    - WOCBP must have a negative urine pregnancy test (minimum
    sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
    the start of study medication.
    - Women must not be breastfeeding.
    - Men who are sexually active with WOCBP must use any contraceptive
    method with a failure rate of less than 1% per year.
    - Women who are not of childbearing potential (ie, who are
    postmenopausal or surgically sterile; see Section 3.3.3 for the definition
    of WOCBP) and azoospermic men do not require contraception.
    E.4Principal exclusion criteria
    1) Target Disease Exceptions
    a) Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
    b) Clinically significant (moderate or severe) mitral stenosis
    c) Cardiac valvular disease requiring surgery
    2) Medical History and Concurrent Diseases
    a) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments).
    b) Patient with serious bleeding in the last 6 months or with a lesion or condition at high risk
    of bleeding such as:
    • Active peptic ulcer disease, current or recent gastrointestinal ulceration
    •Known or suspected oesophageal varices
    •Recent ischemic stroke (within 7 days)
    •Recent brain or spinal injury or intracranial haemorrhage
    •Recent brain, spinal or ophthalmic surgery
    •Arteriovenous malformations,
    •Vascular aneurysms
    •Major intraspinal or intracerebral vascular abnormalities
    •Documented hemorrhagic tendencies or blood dyscrasias
    •Presence of malignant neoplasms at high risk of bleeding
    c) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, and/or diastolic BP > 100 mm Hg)
    d) Active infective endocarditis
    e) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
    f) Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical.
    g) Severe co-morbid condition with life expectancy ≤ 1 year
    3) Physical and Laboratory Test Findings
    a) Severe renal insufficiency (creatinine clearance must be calculated -
    Cockroft-Gault - in all patients; any patient with a calculated creatinine
    clearance <15 ml/min is excluded) or patients undergoing dialysis.
    b) ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 2 times upper limit of normal or a total bilirubin > 1.5 times upper limit of normal (unless an alternative causative factor [e.g., Gilbert’s syndrome] is identified)
    c) Haemoglobin < 9 g/dL
    d) Platelet count < 100,000/mm3
    4) Allergies and Adverse Drug Reaction
    a) Allergy or adverse reaction to apixaban or any of the excipients
    5) Sex and Reproductive Status
    a) Women who are pregnant or breast feeding
    b) Women of child bearing potential (WOCBP, see Section 3.3.3 for definition) who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy.
    c) Sexually active fertile men not willing to use effective birth control if their partners are WOCBP
    6) Prohibited Treatments and/or Therapies
    a) See Section 3.4.1 of the protocol (Prohibited and/or Restricted
    Treatments) for therapies which are prohibited at study entry
    b) Patients previously included or currently enrolled in clinical trials of
    apixaban
    c) Required treatment with ASA > 165 mg/day
    d) Simultaneous treatment with a thienopyridine (e.g., clopidogrel,
    ticlopidine; see Section 3.4.2.1, Acetylsalicylic acid [ASA] and
    Thienopyridines) or prasugrel or ticagrelor
    e) Patients receiving rivaroxaban, dabigatran, or apixaban
    f) Planned major surgery or/and invasive procedure
    g) Planned atrial fibrillation or flutter ablation procedure
    h) Planned cardioversion
    7) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated
    b) Subjects who are compulsorily detained for treatment of either a
    psychiatric or physical (eg, infectious disease) illness
    c) Use of an unapproved, investigational drug or device within the past
    30 days or prior participation into an apixaban clinical study
    d) Inability to comply with protocol visit and activity requirements
    e) Patients unable to self-administer study medication
    f) Patients who are hospitalized or scheduled to be hospitalized or for
    whom treatment is administered by a third person (eg, nurse, relatives).
    g) Patients in long term residential care.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the percentage of days with a correct execution of the apixaban dosing regimen during 24 weeks. This endpoint will be compared between the two study groups: Standard Of Care (SOC) information or additional education.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 weeks
    E.5.2Secondary end point(s)
    - Within each study group, percentage of days with a correct execution of the apixaban dosing regimen during the 12 to 24 weeks period compared with during the first 12 weeks.
    - Adherence to apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group.
    - Risk factors indicative of non-adherence at 24 and 48 weeks.
    - Serious adverse events and other AEs, including major bleeding (ISTH)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 24 and 48 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Treatment adherence.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care vs. additional education programme
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA335
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit Last Subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1112
    F.4.2.2In the whole clinical trial 1112
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-20
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