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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04174859|
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : July 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Non-valvular Atrial Fibrillation||Drug: Rivaroxaban (Xarelto, BAY59-7939)|
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation|
|Actual Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Start treatment with rivaroxaban at the discretion of physician.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Treatment dose is following the description of physicians.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174859
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 email@example.com|
|Multiple Locations, Italy|