Clinical trial NCT04356989: Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function
Official title: Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Keywords: Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2020-04-22
Enrollment: 493
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of Taiwanese NVAF patients with documented CrCl of 15-50 mL/min, requiring rivaroxaban for the prevention of stroke or non-central nervous system (CNS) systemic embolism (SE). Patients must also meet all the eligibility for the study.

Brief summary: In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 20 years of age
* Diagnosis of non-valvular atrial fibrillation (NVAF)
* Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
* Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)

Exclusion Criteria:

* Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics
* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Planned treatment with other anticoagulants
* Expected renal-replacement therapy within the next 3 months

Primary outcomes:
measure: Major bleeding events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 12 months
measure: Occurrence of All-cause mortality
timeFrame: Up to 12 months
measure: Occurrence of non-major bleeding events
timeFrame: Up to 12 months
measure: Occurrence of symptomatic thromboembolic events
timeFrame: Up to 12 months
measure: Day(s) of rivaroxaban treatment: start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy (in case of treatment discontinuation, switch, or interruption, the reason will be recorded)
timeFrame: Up to 12 months
measure: Changes in creatinine clearance (CrCl) from baseline
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
References: