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 (RITMUS-AF)

• ClinicalTrials.gov Identifier: NCT04174859
• Recruitment Status: Recruiting
• First Posted: November 22, 2019
• Last Update Posted: February 21, 2021
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: November 21, 2019
• First Posted Date: November 22, 2019
• Last Update Posted Date: February 21, 2021
• Actual Study Start Date: December 10, 2019
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2019)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2019)

• 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
• Reason for dose change of rivaroxaban therapy [ Time Frame: 24 months ]
  • Change in Creatinine Clearance (CrCL)
  • Insufficient therapeutic effect
  • Adverse event
• 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
• Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score) [ Time Frame: 24 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• 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.
• Condition: Non-valvular Atrial Fibrillation

Intervention

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Treatment dose is following the description of physicians.

Study Groups/Cohorts

NVAF patients

Start treatment with rivaroxaban at the discretion of physician.

Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 21, 2019): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Bayer Clinical Trials Contact; (+)1-888-84 22937; clinical-trials-contact@bayer.com

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04174859
• Other Study ID Numbers: 20999
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC
• Investigators: Not Provided
• PRS Account: Bayer
• Verification Date: February 2021