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)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

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 Type: Observational
• Enrollment (Actual): 3055

Contacts and Locations

Study Locations

• China
  • HangZhou, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Rivaroxaban (Xarelto, BAY 59-7939); Decision regarding dose and duration of treatment made at the discretion of the attending investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Symptomatic thromboembolic events	Collected as serious or non-serious adverse events	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	Up to 30 months
Treatment satisfaction questionnaire		Up to 30 months
Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories		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	Up to 30 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Scientific Affairs, LLC

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): February 21, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: rivaroxaban,; non-interventional,; atrial fibrillation,; stroke prevention,
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Stroke; Embolism; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 16819; XA1207CN (Other Identifier: Company internal)