Atrial FibrillationXaMINANCT03284762
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Bayer at 2 sites in 2 countries.
Trial summary
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 1,216 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Sep 2017to 20 Nov 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation
Who may be able to join
- Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
- Diagnosis of NVAF
- Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
- Treatment naïve regarding stroke prevention for atrial fibrillation
- Signed informed consent
Who cannot join
- Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
- Patients participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.
Read the detailed description
The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve NVAF patients in Korea and Taiwan | Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation 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, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with:
- A fall in hemoglobin of ≥2 g/dL, or
- A transfusion of ≥2 units of packed red blood cells or whole blood, or
- Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or
- Death.
Measured: Up to one year
Secondary outcomes (6)
AEs
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Measured: Up to one year
SAEs
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Measured: Up to one year
All-cause mortality
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Measured: Up to one year
Non-major bleeding events
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Measured: Up to one year
Symptomatic thromboembolic events
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Measured: Up to one year
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
Start date and stop date will be collected to receive information on drug persistence
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start11 Sep 2017
- Primary completion9 Aug 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- 1,216 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
- NCT03284762
- Sponsor's protocol ID
- 18981
- Acronym
- XaMINA
- Status last verified
- Nov 2020
- First submitted
- 14 Sep 2017
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Publications
Liu PY, Choi EK, Kim TS, Kuo JY, Lee JM, On YK, Park SW, Park HW, Shin DG, Wang L, Yen HW, Lee MH; XaMINA Investigators. XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naive Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia. Adv Ther. 2022 Jul;39(7):3316-3333. doi: 10.1007/s12325-022-02102-8. Epub 2022 May 26.
PubMed 35616848
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03284762
- Acronym / sponsor ID
- XaMINA / 18981
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 15 Sep 2017 (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.
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.
Detailed description
The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve NVAF patients in Korea and Taiwan | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation
Key inclusion criteria (5 listed)
- Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan)
- Diagnosis of NVAF
- Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
- Treatment naïve regarding stroke prevention for atrial fibrillation
- Signed informed consent
Key exclusion criteria (2 listed)
- Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC)
- Patients participating in an investigational program with interventions outside of routine clinical practice
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)Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function | Drug | Treatment-naïve NVAF patients in Korea and Taiwan |
Primary outcome
Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
Time frame: Up to one year
Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with: * A fall in hemoglobin of ≥2 g/dL, or * A transfusion of ≥2 units of packed red blood cells or whole blood, or * Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or * Death.
6 secondary outcomes
AEs
Time frame: Up to one year
SAEs
Time frame: Up to one year
All-cause mortality
Time frame: Up to one year
Non-major bleeding events
Time frame: Up to one year
Symptomatic thromboembolic events
Time frame: Up to one year
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
Time frame: Up to one year
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 24 Nov 2020.
- Derived from this study: PubMed 35616848Liu PY, Choi EK, Kim TS, Kuo JY, Lee JM, On YK, Park SW, Park HW, Shin DG, Wang L, Yen HW, Lee MH; XaMINA Investigators. XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naive Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia. Adv Ther. 2022 Jul;39(7):3316-3333. doi: 10.1007/s12325-022-02102-8. Epub 2022 May 26.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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Atrial Fibrillation (AF)
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bayer at 2 sites in 2 countries.
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 5 inclusion and 2 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, 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, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs) (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284762, which also lists 1 linked publication.
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 24 Nov 2020.