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
XARETO
Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.
1 other identifier
observational
493
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2023
CompletedDecember 28, 2023
December 1, 2023
2.5 years
April 21, 2020
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major bleeding events
Up to 12 months
Secondary Outcomes (6)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Up to 12 months
Occurrence of All-cause mortality
Up to 12 months
Occurrence of non-major bleeding events
Up to 12 months
Occurrence of symptomatic thromboembolic events
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)
Up to 12 months
- +1 more secondary outcomes
Study Arms (1)
Rivaroxaban
Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).
Interventions
The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Many Locations
Multiple Locations, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 22, 2020
Study Start
May 13, 2020
Primary Completion
November 15, 2022
Study Completion
January 16, 2023
Last Updated
December 28, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.