Rivaroxaban Evaluation in Real Life Settings

NCT02444221 | Completed DMC

• 1 other identifier: TRI08890
• Study Type: observational
• Target: 5,278
• Locations: 2 countries
• Sites: 2

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Atrial Fibrillation; Rivaroxaban; Stroke

Outcome Measures

Primary Outcomes (2)

• Rate of Stroke in Registry participants

  To assess the rate of stroke and systemic embolisation in registry participants

  2 years

• Rate of Systemic Embolisation in Registry participants

  To assess the rate of stroke and systemic embolisation in registry participants

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females aged 18 years and over

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thrombosis Research Institute: lead
• Bayer: collaborator

Study Sites (2)

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

Paris, France

Location

Thrombosis Research Institute

London, SW3 6LR, United Kingdom

Location

Related Publications (14)

• Waldo AL, Becker RC, Tapson VF, Colgan KJ; NABOR Steering Committee. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol. 2005 Nov 1;46(9):1729-36. doi: 10.1016/j.jacc.2005.06.077. Epub 2005 Oct 10.

  PMID: 16256877 BACKGROUND

• Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987 Sep;147(9):1561-4.

  PMID: 3632164 BACKGROUND

• Rockson SG, Albers GW. Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation. J Am Coll Cardiol. 2004 Mar 17;43(6):929-35. doi: 10.1016/j.jacc.2003.11.028.

  PMID: 15028346 BACKGROUND

• Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 BACKGROUND

• Bogousslavsky J, Van Melle G, Regli F, Kappenberger L. Pathogenesis of anterior circulation stroke in patients with nonvalvular atrial fibrillation: the Lausanne Stroke Registry. Neurology. 1990 Jul;40(7):1046-50. doi: 10.1212/wnl.40.7.1046.

  PMID: 2356005 BACKGROUND

• Camm AJ, Obel OA. Epidemiology and mechanism of atrial fibrillation and atrial flutter. Am J Cardiol. 1996 Oct 17;78(8A):3-11. doi: 10.1016/s0002-9149(96)00559-0. No abstract available.

  PMID: 8903269 BACKGROUND

• Go AS, Fang MC, Singer DE. Antithrombotic therapy for stroke prevention in atrial fibrillation. Prog Cardiovasc Dis. 2005 Sep-Oct;48(2):108-24. doi: 10.1016/j.pcad.2005.06.007.

  PMID: 16253651 BACKGROUND

• Emmerich J, LeHeuzey J-Y, Bath PMW, Connolly SJ. Indication for antithrombotic therapy for atrial fibrillation: reconciling the guidelines with clinical practice. European Heart Journal Supplements 2005;7(Supplement C):C28-C33

  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.

  PMID: 17569677 BACKGROUND

• European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.

  PMID: 20802247 BACKGROUND

• 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.

  PMID: 18574273 BACKGROUND

• 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.

  PMID: 16885201 BACKGROUND

• Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.

  PMID: 19762550 BACKGROUND

• 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.

  PMID: 31169831 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ajay Kakkar

  Thrombosis Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: July 1, 2015
• Primary Completion: May 30, 2019
• Study Completion: September 30, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (1)