Rivaroxaban Evaluation in Real Life Settings (RIVER)

May 4, 2021 updated by: Thrombosis Research Institute
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
  • United Kingdom
      • London, United Kingdom, SW3 6LR
        • Thrombosis Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Males and females aged 18 years and over

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Stroke in Registry participants
Time Frame: 2 years
To assess the rate of stroke and systemic embolisation in registry participants
2 years
Rate of Systemic Embolisation in Registry participants
Time Frame: 2 years
To assess the rate of stroke and systemic embolisation in registry participants
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrombosis Research Institute

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRI08890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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