Trial Condition(s):

Non-valvular Atrial Fibrillation

Study aims to collect information in routine clinical practice in Italy about the number of patients suffering from irregularly heart beats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF) who stopped or changed rivaroxaban treatment (RITMUS-AF)

Bayer Identifier:

20999

ClinicalTrials.gov Identifier:

NCT04174859

EudraCT Number:

Not Available

Study Completed

Trial Purpose

While it is well known that stopping or changing medication with blood thinners in patients who suffer from non-valvular atrial fibrillation (NVAF) increases the risk of ischemic stroke (a condition which occurs when a vessel supplying blood to the brain is obstructed), bleeding or thromboembolism (a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel), limited data are available on the number of NVAF patients and the reasons why NVAF patients in Italy stop or change their treatment with blood thinners to prevent stroke or thromboembolism.
By following the NVAF patients in routine clinical practice in Italy who are treated with rivaroxaban to prevent stroke or systemic embolism researchers want to find out how many NVAF patients and for what reasons NVAF patients stopped or changed rivaroxaban treatment. Study data will be collected through patients' routine visits at their treating doctor over a period of 24 months for each patient.

Inclusion Criteria
- Age >= 18
- Patient with a diagnosis of NVAF
- New user to rivaroxaban, naïve or non naïve to treatment with oral anticoagulant
- Patient for whom the decision to initiate treatment with rivaroxaban was made as per physician's routine treatment practice for prevention of stroke and non-central nervous system (CNS) systemic embolism
- Signed an informed consent
Exclusion Criteria
- Patient with heart valve replacement
- Patient is participating in an investigational program with interventions outside of routine clinical practice

Trial Summary

Enrollment Goal
737
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, Italy

Status
Recruiting
 

Trial Design