Non-valvular Atrial Fibrillation (NVAF)XARETONCT04356989
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
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Bayer at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF)
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 493 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 May 2020to 16 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.
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.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE). Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding events
Measured: Up to 12 months
Secondary outcomes (6)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 12 months
Occurrence of All-cause mortality
Measured: Up to 12 months
Occurrence of non-major bleeding events
Measured: Up to 12 months
Occurrence of symptomatic thromboembolic events
Measured: 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)
Measured: Up to 12 months
Changes in creatinine clearance (CrCl) from baseline
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start13 May 2020
- Primary completion15 Nov 2022
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356989
- Sponsor's protocol ID
- 20901
- Acronym
- XARETO
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.
- ClinicalTrials.gov ID
- NCT04356989
- Acronym / sponsor ID
- XARETO / 20901
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 13 May 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)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. | Drug | Rivaroxaban |
Primary outcome
Major bleeding events
Time frame: Up to 12 months
6 secondary outcomes
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 12 months
Occurrence of All-cause mortality
Time frame: Up to 12 months
Occurrence of non-major bleeding events
Time frame: Up to 12 months
Occurrence of symptomatic thromboembolic events
Time 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)
Time frame: Up to 12 months
Changes in creatinine clearance (CrCl) from baseline
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Bayer at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding events (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.