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RIVER: Rivaroxaban Evaluation in Real Life Settings

Sponsor
Thrombosis Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02444221
Collaborator
Bayer (Industry)
5,278
Enrollment
2
Locations
63
Actual Duration (Months)
2639
Patients Per Site
41.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at least one additional investigator-determined risk factor for stroke in real-life practice.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This large global registry focuses on studying Atrial Fibrillation (AF) and evaluating characteristics, management and outcomes of patients treated with Rivaroxaban. The RIVER registry is observational, decisions on patient management are determined by the health care professional and the patient and not by the protocol. Patients are therefore treated according to normal local practice and the drug label/relevant product information of any drugs administered to them.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    5278 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Rivaroxaban Evaluation in Real Life Settings
    Actual Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    May 30, 2019
    Actual Study Completion Date :
    Sep 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Stroke in Registry participants [2 years]

      To assess the rate of stroke and systemic embolisation in registry participants

    2. Rate of Systemic Embolisation in Registry participants [2 years]

      To assess the rate of stroke and systemic embolisation in registry participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent

    • Age 18 years and over

    • New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional investigator-determined risk factor for stroke

    • Initial treatment with Rivaroxaban following AF diagnosis

    Exclusion Criteria:

    • No further follow-up envisaged or possible within enrolling hospital or with associated primary care physician.

    • Patients with transient AF secondary to a reversible cause.

    • Patients participating in an interventional study that dictates treatments, visit frequency or diagnostic procedures

    • Not treated with Rivaroxaban as first treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou Paris France
    2 Thrombosis Research Institute London United Kingdom SW3 6LR

    Sponsors and Collaborators

    • Thrombosis Research Institute
    • Bayer

    Investigators

    • Study Director: Ajay Kakkar, Thrombosis Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Thrombosis Research Institute
    ClinicalTrials.gov Identifier:
    NCT02444221
    Other Study ID Numbers:
    • TRI08890
    First Posted:
    May 14, 2015
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Thrombosis Research Institute
    Atrial Fibrillation
    Rivaroxaban
    Stroke
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 7, 2021