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OpenTrials
Completed

NCT Number: NCT02444221

Rivaroxaban Evaluation in Real Life Settings

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of Stroke in Registry participants

    Time frame: 2 years

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

  2. Rate of Systemic Embolisation in Registry participants

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Thrombosis Research Institute

Other

Collaborators

  • Bayer

Registry information

Acronym: RIVER

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 14, 2015
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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