Clinical trial NCT01750788: Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia
Official title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Stroke
Embolism
Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-12-17
Enrollment: 2297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism

Brief summary: This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.

Primary outcomes:
measure: Adjudicated major bleeding events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: All cause mortality
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary outcomes:
measure: Adjudicated symptomatic thromboembolic events
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Healthcare resource
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Adverse events rates in the different AF risk factor categories
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
measure: Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study
timeFrame: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Other outcomes:
Locations:
city: Many Locations
country: Hong Kong
city: Many Locations
country: India
city: Many Locations
country: Indonesia
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Malaysia
city: Many Locations
country: Pakistan
city: Many Locations
country: Philippines
city: Many Locations
country: Singapore
city: Many Locations
country: Taiwan
city: Many Locations
country: Thailand
city: Many Locations
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.