Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)
NCT ID: NCT03455439
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
552 participants
OBSERVATIONAL
2018-03-16
2022-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rivaroxaban
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion
Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of nonvalvular Atrial Fibrilation (AF).
* Patients with a diagnosis of chronic Heart Failure, New York Heart Association (NYHA) class I-IV HF with preserved Ejection Fraction (HFpEF), HF with reduced EF (HFrEF) or HF with mid-range EF (HFmrEF).
* Patients receiving antithrombotic treatment because of AF, with rivaroxaban since at least 4 months before entering the study.
* Patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study.
Exclusion Criteria
* Patients who started rivaroxaban after the start of the inclusion period.
* Patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty).
* Patients with severe cognitive impairment.
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , Spain
Countries
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References
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Gomez Doblas JJ, Cepeda-Rodrigo JM, Agra Bermejo R, Blanco Labrador E, Blasco MT, Carrera Izquierdo M, Lekuona I, Recio Mayoral A, Rafols C, Manito N. Outcomes and factors associated with mortality in patients with atrial fibrillation and heart failure: FARAONIC study. Clin Cardiol. 2023 Nov;46(11):1390-1397. doi: 10.1002/clc.24106. Epub 2023 Aug 18.
Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Other Identifiers
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19584
Identifier Type: -
Identifier Source: org_study_id
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