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NOAH - AFNET 6

  • Research type

    Research Study

  • Full title

    Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes

  • IRAS ID

    194491

  • Contact name

    Andreas Götte, Professor

  • Contact email

    noah@af-net.eu

  • Sponsor organisation

    Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]

  • Eudract number

    2015-003997-33

  • ISRCTN Number

    ISRCTN17309850

  • Clinicaltrials.gov Identifier

    NCT02618577

  • Duration of Study in the UK

    7 years, 6 months, 0 days

  • Research summary

    Patients with Atrial Fibrillation (irregular rhythm and frequency in the hearts atrium) (AF) are known to have an increased risk of stroke. In order to prevent stroke, these patients are treated with anticoagulants (drugs preventing the clotting of blood). Recent advances made in implanted pacemakers and defibrillators have enabled detection of atrial high rate episodes (AHRE) (episodes of increased frequency in the atrium) that are believed to be precursors of AF. Patients with AHREs also have an increased risk of stroke. However, anticoagulants are not commonly used in these patients.
    The aim of this trial is to examine, if the new oral anticoagulant edoxaban reduces the risk of stroke in patients with AHREs.
    About 2400 patients in 15 European countries will be included in this trial. Patients must be at least 65 years of age, have an increased stroke risk (at least a score of 2 in the ChadVasc scoring system) and have an implanted pacemaker or defibrillator capable of recording AHREs .
    Patients included in the trial will be randomly assigned to either treatment with edoxaban or standard treatment (no treatment or treatment with acetylsalicylacid (“Aspirin”). The occurrence of stroke, cardiovascular death and systemic embolism will be compared between these groups. Neither patients, nor their doctors know which group the patient belongs to.
    The trial is designed as an event-driven trial, meaning, that the end of the trial is not determined by any fixed date or duration, but by the occurrence of certain events. In this case the trial will end, once 222 first occurrences of stroke, cardiovascular death or systemic embolism (blockage of blood vessels in the body) in patients have been counted, presumably by the end of 2019.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    16/EM/0172

  • Date of REC Opinion

    23 May 2016

  • REC opinion

    Further Information Favourable Opinion