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

Completed

• Conditions: Stroke
• Interventions: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

• Registration Number: NCT02784717
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-27
• Study Start: 2016-05-11
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Primary Completion: 2019-02-21
• Study Completion: 2019-09-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3055

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

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Exclusion Criteria

• NA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban (Xarelto, BAY 59-7939)	Rivaroxaban (Xarelto, BAY 59-7939)	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.

Primary Outcome Measures

Name	Time	Method
Number of Major bleeding events	Up to 30 months	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

Secondary Outcome Measures

Name	Time	Method
Number of Symptomatic thromboembolic events	Up to 30 months	Collected as serious or non-serious adverse events
Treatment satisfaction questionnaire	Up to 30 months
Number of Non-major bleeding	Up to 30 months	Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings
Number of each reason for any switch from or interruption of rivaroxaban treatment	Up to 30 months	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
Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories	Up to 30 months