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RIVER Registry – RIVaroxaban Evaluation in Real life setting

  • Research type

    Research Study

  • Full title

    Prospective, multicentre, international Registry of male and female patients newly diagnosed with Atrial Fibrillation and treated with Rivaroxaban

  • IRAS ID

    172341

  • Contact name

    John Camm

  • Contact email

    jcamm@sgul.ac.uk

  • Sponsor organisation

    Thrombosis Research Institute

  • Clinicaltrials.gov Identifier

    ClinicalTrials.gov Identifier, Pending; EudraCT, 2015-000680-14

  • Duration of Study in the UK

    3 years, 7 months, 28 days

  • Research summary

    Atrial fibrillation (AF) is the most common type of irregular heart rhythm. An irregular heart rhythm is also known as an arrhythmia.

    It is estimated that 1 in 4 individuals aged 40 years will develop AF. In 2007, 6.3 million people in the US, Japan, Germany, Italy, Spain, France, and UK were living with diagnosed AF. Owing to the aging population, this number is expected to double within 30 years.

    Non-valvular atrial fibrillation (AF) is responsible for 50% of cardioembolic strokes:
    • 25% lifetime risk of AF for those aged >40 years
    • 5 x increase in risk of stroke with non-valvular AF
    • 50% 1-year mortality rate in AF-related stroke

    Stroke is responsible for 10% of deaths worldwide:
    • 15 million strokes
    • 5.7 million deaths
    • 4th highest economic burden

    Uncertainty persists about how AF is managed in the real world and how these treatment patterns affect patient and population outcomes. This is a problem in relation to treatment guidelines, in specific patient populations and across various care settings.

    The registry will enhance understanding of the burden of thromboembolic stroke and identify opportunities for the incorporation of innovations designed to improve safety, outcomes and utiliSation of healthcare resources.

    This is a non-interventional, multi-centre, prospective Registry. The registry’s design and methodology will provide representative, real-world insights, and will clarify AF treatments and outcomes for patients, clinicians and healthcare providers as they evolve over time.

    Patients with newly diagnosed non-valvular AF of any cause with at least one Investigator-determined risk factor for stroke will be enrolled.

    It is anticipated that the total registry duration will be approximately 3.5 years allowing approximately 18 months for recruitment and 2 year follow up of the last patient enrolled.

    In the UK we will be looking to select primary care and secondary sites to take part in the registry.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    15/SC/0283

  • Date of REC Opinion

    1 May 2015

  • REC opinion

    Unfavourable Opinion