Rivaroxaban Evaluation in Real Life Settings

NCT ID: NCT02444221

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2020-09-30

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.

Conditions

Atrial Fibrillation; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Thrombosis Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajay Kakkar

Role: STUDY_DIRECTOR

Thrombosis Research Institute

Locations

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

Paris, , France

Thrombosis Research Institute

London, , United Kingdom

Countries

France; United Kingdom

References

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Reference Type: BACKGROUND

Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.

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Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S; Task Force on Practice Guidelines, American College of Cardiology/American Heart Association; Committee for Practice Guidelines, European Society of Cardiology; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J. 2006 Aug;27(16):1979-2030. doi: 10.1093/eurheartj/ehl176. No abstract available.

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Beyer-Westendorf J, Camm AJ, Fox KAA, Le Heuzey JY, Haas S, Turpie AGG, Virdone S, Kakkar AK; RIVER Registry Investigators. International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER). Thromb J. 2019 Apr 25;17:7. doi: 10.1186/s12959-019-0195-7. eCollection 2019.

Reference Type: DERIVED

PMID: 31169831 (View on PubMed)

Other Identifiers

TRI08890

Identifier Type: -

Identifier Source: org_study_id