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

Bayer3,055 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,055

Conditions

Stroke

Interventions

Rivaroxaban (Xarelto, BAY 59-7939)DRUG

Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 practice Exclusion Criteria: * NA

Locations (1)

Unnamed facility

Hangzhou, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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