check_circleStudy Completed

non-valvular atrial fibrillation (NVAF)

Bayer Identifier:

20901

ClinicalTrials.gov Identifier:

NCT04356989

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

All

Age

20 - N/A
  • - 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)
  • - 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

Trial summary

Enrollment Goal
493
Trial Dates
May 2020 - January 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Taiwan

Primary Outcome

  • Major bleeding events
    date_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 mortality
    date_rangeTime Frame:
    Up to 12 months
  • Occurrence of non-major bleeding events
    date_rangeTime Frame:
    Up to 12 months
  • Occurrence of symptomatic thromboembolic events
    date_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 baseline
    date_rangeTime Frame:
    Up to 12 months

Trial design

Xarelto® for the prevention of stroke and noncentral nervous systemic embolism in non-valvular atrial fibrillation with REnal impairment in Taiwanese population.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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