Clinical trial NCT03284762: Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation
Official title: Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2017-09-15
Enrollment: 1216
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation

Brief summary: The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.

Detailed description: The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Eligibility criteria: Inclusion Criteria:

* Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
* Diagnosis of NVAF
* Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
* Treatment naïve regarding stroke prevention for atrial fibrillation
* Signed informed consent

Exclusion Criteria:

* Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
* Patients participating in an investigational program with interventions outside of routine clinical practice

Primary outcomes:
measure: Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
timeFrame: Up to one year
Secondary outcomes:
measure: AEs
timeFrame: Up to one year
measure: SAEs
timeFrame: Up to one year
measure: All-cause mortality
timeFrame: Up to one year
measure: Non-major bleeding events
timeFrame: Up to one year
measure: Symptomatic thromboembolic events
timeFrame: Up to one year
measure: Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
timeFrame: Up to one year
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Different facilities
city: Multiple Locations
country: Taiwan
facility: Different facilities
Study officials:
References:
citation: Liu PY, Choi EK, Kim TS, Kuo JY, Lee JM, On YK, Park SW, Park HW, Shin DG, Wang L, Yen HW, Lee MH; XaMINA Investigators. XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naive Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia. Adv Ther. 2022 Jul;39(7):3316-3333. doi: 10.1007/s12325-022-02102-8. Epub 2022 May 26.