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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) (FARAONIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455439
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with Atrial Fibrilation and HF treated with rivaroxaban.

Condition or disease Intervention/treatment
Heart Failure Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Design
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Study Type : Observational
Actual Enrollment : 652 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : July 17, 2021
Actual Study Completion Date : January 5, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Groups and Cohorts
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Group/Cohort Intervention/treatment
Rivaroxaban
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion
 Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by the treating physician


Outcome Measures
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Primary Outcome Measures :
  1. Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation [ Time Frame: Up to 24 months or early termination ]

Secondary Outcome Measures :
  1. Date of death [ Time Frame: Up to 24 months or early termination ]
  2. Date of all hospitalizations or admissions to emergency service [ Time Frame: Up to 24 months or early termination ]
    due to a HF exacerbation or all cause


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion that attend the Cardiology Units or Internal Medicine Units at Spanish hospitals and private clinics.
Criteria

Inclusion Criteria:

  • Adult males and females aged 18 years or older.
  • 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 participating in a research program which involves some intervention beyond clinical practice.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455439


Locations
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Spain
Many Locations
Multiple Locations, Spain
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03455439    
Other Study ID Numbers: 19584
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Disease Progression
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Disease Attributes
 Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants