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

NCT ID: NCT04174859

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

812 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-12-12

Brief Summary

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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

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Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NVAF patients

Start treatment with rivaroxaban at the discretion of physician.

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Treatment dose is following the description of physicians.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Treatment dose is following the description of physicians.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Multiple Locations, , Italy

Site Status

Countries

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Italy

Related Links

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https://clinicaltrials.bayer.com/

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Other Identifiers

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20999

Identifier Type: -

Identifier Source: org_study_id

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