Clinical trial NCT04174859: 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
Official title: Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: Atrial Fibrillation (AF)
NVAF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2019-11-22
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NVAF patients who are treated with rivaroxaban to prevent stroke or non-CNS systemic embolism. Owing to the observational study design, patients will only be enrolled in the study if the decision to treat with rivaroxaban has been made by the treating physician in advance and independent of study inclusion. The decision to prescribe rivaroxaban is solely at the discretion of the investigator and made in accordance with his/her experience in accordance to SmPC.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Date of start of rivaroxaban treatment
timeFrame: 24 months
measure: Date of stop of rivaroxaban treatment
timeFrame: 24 months
measure: Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.
timeFrame: 24 months
Secondary outcomes:
measure: Reasons for discontinuation of rivaroxaban therapy
timeFrame: 24 months
measure: Reason for dose change of rivaroxaban therapy
timeFrame: 24 months
measure: Reason for switch to other therapy
timeFrame: 24 months
measure: Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)
timeFrame: 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Italy
facility: Many locations
Study officials:
References: