Rivaroxaban Evaluation in Real Life Settings

Completed

• Conditions: Stroke; Atrial Fibrillation

• Registration Number: NCT02444221
• Lead Sponsor: Thrombosis Research Institute

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.

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 Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2015-07-01
• Primary Completion: 2019-05-30
• Study Completion: 2020-09-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5278

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Stroke in Registry participants	2 years	To assess the rate of stroke and systemic embolisation in registry participants
Rate of Systemic Embolisation in Registry participants	2 years	To assess the rate of stroke and systemic embolisation in registry participants

Trial Locations

Locations (2)

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

Thrombosis Research Institute; 🇬🇧 London, United Kingdom