An observational study in Stroke, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Bayer · Observational
This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.
3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 3,055 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban within approved indication to prevent stroke or non-CNS systemic embolism has been made.
Exclusion Criteria:
Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made.
Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
Number of Major bleeding events
Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with: 1. a fall in haemoglobin of ≥2 g/dL, or 2. a transfusion of ≥2 units of packed red blood cells or whole blood, or 3. occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or 4. death
Time frame: Up to 30 months
Number of Symptomatic thromboembolic events
Collected as serious or non-serious adverse events
Time frame: Up to 30 months
Number of Non-major bleeding
Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings
Time frame: Up to 30 months
Treatment satisfaction questionnaire
Time frame: Up to 30 months
Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories
Time frame: Up to 30 months
Number of each reason for any switch from or interruption of rivaroxaban treatment
If the patients switch from or interruption of rivaroxaban treatment, patients or physicians will be asked by several questions about the reasons of the switch and interruption, and collected in CRF. The reasons will be described by frequency distributions. Reason choice as below: 1. Patient choice 2. Insufficient therapeutic effect 3. Adverse event 4. Surgery 5. Dentistry 6. Renal function change
Time frame: Up to 30 months
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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