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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables" | Up to one year |
| SAEs | All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables" |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Different facilities | Multiple Locations | South Korea | ||||
| Different facilities |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35616848 | Derived | 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. |
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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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|
| 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" | 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" | 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" | 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 | Up to one year |
| Multiple Locations |
| Taiwan |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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