check_circleStudy Completed
Non-valvular atrial fibrillation
Bayer Identifier:
20999
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
812Trial Dates
December 2019 - December 2022Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Italy |
Primary Outcome
- Date of start of rivaroxaban treatmentdate_rangeTime Frame:24 months
- Date of stop of rivaroxaban treatmentdate_rangeTime Frame:24 months
- Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.date_rangeTime Frame:24 months
Secondary Outcome
- 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 switchdate_rangeTime Frame:24 months
- Reason for dose change of rivaroxaban therapy- Change in Creatinine Clearance (CrCL) - Insufficient therapeutic effect - Adverse eventdate_rangeTime Frame: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 switchdate_rangeTime Frame:24 months
- Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)date_rangeTime Frame:24 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A