Trial Condition(s):

Heart Failure

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)

Bayer Identifier:

19584

ClinicalTrials.gov Identifier:

NCT03455439

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
552
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Spain

Status
Completed
 

Trial Design