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    Summary
    EudraCT Number:2016-002353-38
    Sponsor's Protocol Code Number:OHIRC20150866
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-11-16
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002353-38
    A.3Full title of the trial
    The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter
    Ablation for Atrial Fibrillation Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OCEAN
    A.3.2Name or abbreviated title of the trial where available
    OCEAN
    A.4.1Sponsor's protocol code numberOHIRC20150866
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02168829
    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 SponsorOttawa Heart institute Research Corporation
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiotronik Inc Canada
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportBayer Inc
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportCanadian institute for heath research
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    D.2.1.1.1Trade name Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.1Product nameXarelto
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 No
    D.2.1.1.1Trade name acetylsalicylic acid
    D.2.1.1.2Name of the Marketing Authorisation holderany
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.1Product nameacetylsalicylic acid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    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
    Risk of stroke by atrial fibrillation
    E.1.1.1Medical condition in easily understood language
    Increased risk for stroke by atrial fibrillation a heart arrhythmia
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This phase 4 trial investigates whether a strategy of ongoing, long-term
    oral anticoagulation is superior to a strategy of antiplatelet therapy
    (ASA) alone in reducing the incidence of cerebral embolic events in
    moderate risk patients post-successful catheter ablation for atrial
    fibrillation.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are the evaluation of
    - efficacy of rivaroxaban and ASA, respectively, in the reduction of the
    incidence of stroke, systemic embolism or silent cerebral infarction
    - safety of long-term oral anticoagulation after catheter ablation for
    atrial fibrillation
    - cost effectiveness of long-term oral anticoagulation after catheter
    ablation for atrial fibrillation
    - relationship of the atrial fibrillation burden to stroke risk
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be at least one year post-successful catheter ablation(s)
    for atrial fibrillation without evidence of any clinically apparent
    arrhythmia recurrence defined as all of the following:
    No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent)
    from 2-6 months after the last ablation,
    AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after
    6 months after the last ablation AND no AF/AT/AFL on at least 24 hour
    Holter and ECG 2 months before enrolment in the study. The Holter/ECG
    within 2 months of enrolment may also serve as the Holter performed 6
    months or later after the last ablation - see section 2.3.1 for details.
    2. Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients
    in whom female sex or vascular disease are their sole risk factor may not
    be enrolled.
    3. Patient must be >18 years of age.
    4. Patient must have non-valvular AF.
    E.4Principal exclusion criteria
    1. Patient does not meet all of the above listed inclusion criteria.
    2. Patient is unable or unwilling to provide informed consent.
    3. Patient is included in another randomized clinical trial or a clinical trial
    requiring an insurance.
    4. Patient has been on an investigational drug within 30 days of
    enrolment.
    5. Patient has been on strong CYP3A inducers (such as rifampicin,
    phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors
    (such as ketoconazole or protease inhibitors) within 4 days of
    enrolment.
    6. Patient has creatinine clearance < 30 mL/min.
    7. Patient has bleeding contra-indication to oral anticoagulation (such as
    bleeding diathesis, hemorrhagic disorder, significant gastrointestinal
    bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding
    history, fibrinolysis within 48 hours of enrollment).
    8. Patient has other contraindication to oral anticoagulation or treatment
    with antiplatelet agent (such as allergy).
    9. Patient has a contraindication to magnetic resonance imaging (MRI)
    or is unlikely to tolerate due to severe claustrophobia.
    10. Patients with a contraindication to implantation of an implantable
    loop recorder if the patient opts for loop recorder as part of the
    study(such as limited immunocompetence or a wound healing
    disorder).
    11. Patient has valvular atrial fibrillation [reference AHA guidelines].
    12. Patient has a non-arrhythmic condition necessitating long-term oral
    anticoagulation.
    13. Patient had a severe, disabling stroke within one year prior to
    enrollment or any stroke within 14 days of enrollment.
    14. Patient with special risk factors for stroke unrelated to AF,
    specifically known thrombophilia/ hypercoagulability, uncontrolled
    hypertension (systolic blood pressure >180 mmHg and/or diastolic
    blood pressure >100 mmHg within 4 days of enrollment), untreated
    familial hyperlipidemia, known vascular anomaly (intracranial
    aneurysm/ arteriovenous malformation or chronic vascular dissection),
    or known severe carotid disease.
    15. Pregnancy or breastfeeding.
    16. Women of childbearing age who refuse to use a highly effective and
    medically acceptable form of contraception throughout the study.
    17. Patients who are > 85 years of age.
    18. Patients who are critically ill or who have a life expectancy <3 years.
    19. Patients for whom the investigator believes that the trial is not in
    the interest of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is a composite of stroke, systemic embolism, and
    covert embolic stroke as defined by assessment of cerebral magnetic
    resonance imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for the primary endpoint at follow up visits at
    6, 12, 24 and 36 months with an MRI being performed at Baseline and 36
    months for detection of covert stroke.
    E.5.2Secondary end point(s)
    1. Clinical, overt stroke
    2. Incidence of one or more covert MRI stroke(s) > 15 mm3. Composite
    of all major and minor bleeding
    4. Major bleeding only
    5. Minor bleeding only
    6. Intracranial hemorrhage
    7. Transient ischemic attack
    8. All-cause mortality
    9. Net clinical benefit based on reduction in stroke/TIA rate compared to
    major bleeding events
    10. Occurrence of non-primary endpoint MRI changes from baseline to
    final scan
    11. Neuropsychological testing
    12. Quality of life assessment
    13. Cost utilization and cost effectiveness analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for endpoints at follow up visits at 6, 12, 24
    and 36 months with an MRI being performed at baseline and 36 months
    for detection of covert stroke.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Israel
    Belgium
    Germany
    E.8.7Trial has a data monitoring committee Yes
    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 MRI of last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 1002
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 282
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 675
    F.4.2.2In the whole clinical trial 1284
    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 Decision2018-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-26
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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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