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

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT04174859
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2019-12-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NVAF patients	Rivaroxaban (Xarelto, BAY59-7939)	Start treatment with rivaroxaban at the discretion of physician.

Primary Outcome Measures

Name	Time	Method
Date of start of rivaroxaban treatment	24 months
Date of stop of rivaroxaban treatment	24 months
Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.	24 months

Secondary Outcome Measures

Name	Time	Method
Reason for switch to other therapy	24 months	* Ischemic event; * Bleeding and site of bleeding; * Adverse drug reaction; * Drug interaction with other therapies; * New treatment after switch
Reasons for discontinuation of rivaroxaban therapy	24 months	* 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
Reason for dose change of rivaroxaban therapy	24 months	* Change in Creatinine Clearance (CrCL); * Insufficient therapeutic effect; * Adverse event
Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)	24 months

Trial Locations

Locations (1)

Many locations; 🇮🇹 Multiple Locations, Italy