Trial Condition(s):
Stroke
Xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in China: A non-interventional study (XASSURE)
Bayer Identifier:
16819
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
- Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator’s routine treatment practiceExclusion Criteria
-NA
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site HangZhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Xarelto® on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in China: A non-interventional study
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of Major bleeding eventsMajor 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. deathTimeframe: Up to 30 months
Secondary Outcome
- Number of Symptomatic thromboembolic eventsCollected as serious or non-serious adverse eventsTimeframe: Up to 30 months
- Number of Non-major bleedingCollected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedingsTimeframe: Up to 30 months
- Treatment satisfaction questionnaireTimeframe: Up to 30 months
- Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categoriesTimeframe: Up to 30 months
- Number of each reason for any switch from or interruption of rivaroxaban treatmentIf 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 changeTimeframe: Up to 30 months
Additional Information
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