Non-valvular Atrial FibrillationRITMUS-AFNCT04174859
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
An observational study of Non-valvular Atrial Fibrillation, run by Bayer at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 812 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2019to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NVAF patients who are treated with rivaroxaban to prevent stroke or non-CNS systemic embolism. Owing to the observational study design, patients will only be enrolled in the study if the decision to treat with rivaroxaban has been made by the treating physician in advance and independent of study inclusion. The decision to prescribe rivaroxaban is solely at the discretion of the investigator and made in accordance with his/her experience in accordance to SmPC.
Who may be able to join
- 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
Who cannot join
- Patient with heart valve replacement
- Patient is participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation
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.
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Atrial Fibrillation (AF), NVAF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Treatment dose is following the description of physicians.
| Study group | Role | What they receive |
|---|---|---|
| NVAF patients | Start treatment with rivaroxaban at the discretion of physician. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Date of start of rivaroxaban treatment
Measured: 24 months
Date of stop of rivaroxaban treatment
Measured: 24 months
Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.
Measured: 24 months
Secondary outcomes (4)
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
Measured: 24 months
Reason for dose change of rivaroxaban therapy
- Change in Creatinine Clearance (CrCL)
- Insufficient therapeutic effect
- Adverse event
Measured: 24 months
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
Measured: 24 months
Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start10 Dec 2019
- Primary completion30 Jun 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174859
- Sponsor's protocol ID
- 20999
- Acronym
- RITMUS-AF
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2019
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04174859
- Acronym / sponsor ID
- RITMUS-AF / 20999
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- Atrial Fibrillation (AF), NVAF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVAF patients | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Start treatment with rivaroxaban at the discretion of physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NVAF patients who are treated with rivaroxaban to prevent stroke or non-CNS systemic embolism. Owing to the observational study design, patients will only be enrolled in the study if the decision to treat with rivaroxaban has been made by the treating physician in advance and independent of study inclusion. The decision to prescribe rivaroxaban is solely at the discretion of the investigator and made in accordance with his/her experience in accordance to SmPC.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with heart valve replacement
- Patient is participating in an investigational program with interventions outside of routine clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Treatment dose is following the description of physicians. | Drug | NVAF patients |
Primary outcome
Date of start of rivaroxaban treatment
Time frame: 24 months
Date of stop of rivaroxaban treatment
Time frame: 24 months
Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.
Time frame: 24 months
4 secondary outcomes
Reasons for discontinuation of rivaroxaban therapy
Time frame: 24 months
Reason for dose change of rivaroxaban therapy
Time frame: 24 months
Reason for switch to other therapy
Time frame: 24 months
Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation, run by Bayer at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Date of start of rivaroxaban treatment (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.