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

Stroke Clinical Trial

— XASSURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784717
• Other study ID #: 16819
• Secondary ID: XA1207CN
• Status: Completed
• Start date: May 11, 2016
• Est. completion date: September 24, 2019

Study information

• Verified date: August 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3055
• Est. completion date: September 24, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Stroke

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY 59-7939)
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Major bleeding events	Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with: a fall in haemoglobin of =2 g/dL, or; a transfusion of =2 units of packed red blood cells or whole blood, or; occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or; death	Up to 30 months
Secondary	Number of Symptomatic thromboembolic events	Collected as serious or non-serious adverse events	Up to 30 months
Secondary	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	Up to 30 months
Secondary	Treatment satisfaction questionnaire		Up to 30 months
Secondary	Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories		Up to 30 months
Secondary	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	Up to 30 months

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