CompletedNot Applicable

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

Italy812 participantsStarted 2019-12-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Date of start of rivaroxaban treatment

Timeframe: 24 months

Date of stop of rivaroxaban treatment

Timeframe: 24 months

Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.

Timeframe: 24 months

Trial details

NCT IDNCT04174859

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.