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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Treatment dose is following the description of physicians.

Primary outcomes

  1. Date of start of rivaroxaban treatment

    Time frame: 24 months

  2. Date of stop of rivaroxaban treatment

    Time frame: 24 months

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

    Time frame: 24 months

Secondary outcomes

  1. Reasons for discontinuation of rivaroxaban therapy

    Time frame: 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

  2. Reason for dose change of rivaroxaban therapy

    Time frame: 24 months

    • Change in Creatinine Clearance (CrCL)
    • Insufficient therapeutic effect
    • Adverse event

  3. Reason for switch to other therapy

    Time frame: 24 months

    • Ischemic event
    • Bleeding and site of bleeding
    • Adverse drug reaction
    • Drug interaction with other therapies
    • New treatment after switch

  4. Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: RITMUS-AF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2019
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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