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

Non-valvular Atrial Fibrillation Clinical Trial

— RITMUS-AF  

Official title:

Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174859
• Other study ID #: 20999
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: December 12, 2022

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: December 12, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Treatment dose is following the description of physicians.

Locations

Country	Name	City	State
Italy	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Date of start of rivaroxaban treatment		24 months
Primary	Date of stop of rivaroxaban treatment		24 months
Primary	Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.		24 months
Secondary	Reasons for discontinuation of rivaroxaban therapy	therapy discontinuation due to adverse event (AE); therapy discontinuation for non AE related reason; physician decision; patient lost to follow up, no remote contact; patient decision (not related to AE); patient is in stable sinus rhythm; patient decided to terminate study participation but agreed to further use of data collected so far.; patient decided to terminate study participation and refused further use of collected data.; Patient died; Treatment switch	24 months
Secondary	Reason for dose change of rivaroxaban therapy	Change in Creatinine Clearance (CrCL); Insufficient therapeutic effect; Adverse event	24 months
Secondary	Reason for switch to other therapy	Ischemic event; Bleeding and site of bleeding; Adverse drug reaction; Drug interaction with other therapies; New treatment after switch	24 months
Secondary	Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)		24 months

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