check_circleStudy Completed
non-valvular atrial fibrillation (NVAF)
Bayer Identifier:
20901
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
20 - N/ATrial summary
Enrollment Goal
493Trial Dates
May 2020 - January 2023Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Taiwan |
Primary Outcome
- Major bleeding eventsdate_rangeTime Frame:Up to 12 months
Secondary Outcome
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)date_rangeTime Frame:Up to 12 months
- Occurrence of All-cause mortalitydate_rangeTime Frame:Up to 12 months
- Occurrence of non-major bleeding eventsdate_rangeTime Frame:Up to 12 months
- Occurrence of symptomatic thromboembolic eventsdate_rangeTime Frame:Up to 12 months
- 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)date_rangeTime Frame:Up to 12 months
- Changes in creatinine clearance (CrCl) from baselinedate_rangeTime Frame:Up to 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A