Clinical trial NCT02444221: Rivaroxaban Evaluation in Real Life Settings
Official title: Rivaroxaban Evaluation in Real Life Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Keywords: Atrial Fibrillation
Rivaroxaban
Stroke
Lead sponsor: Thrombosis Research Institute
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-05-14
Enrollment: 5278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females aged 18 years and over

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.

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

Primary outcomes:
measure: Rate of Stroke in Registry participants
timeFrame: 2 years
measure: Rate of Systemic Embolisation in Registry participants
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
city: London
country: United Kingdom
facility: Thrombosis Research Institute
Study officials:
affiliation: Thrombosis Research Institute
name: Ajay Kakkar
role: STUDY_DIRECTOR
References:
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citation: 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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citation: Singer DE, Albers GW, Dalen JE, Fang MC, Go AS, Halperin JL, Lip GYH, Manning WJ. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):546S-592S. doi: 10.1378/chest.08-0678.
citation: 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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citation: 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.