Rivaroxaban Evaluation in Real Life Settings

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02444221

Acronym

RIVER

Enrollment

5278

Registered

2015-05-14

Start date

2015-07-01

Completion date

2020-09-30

Last updated

2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

Atrial Fibrillation, Rivaroxaban, Stroke

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France, United Kingdom

Outcome results