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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding events | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Taiwan |
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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| 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 |
| Changes in creatinine clearance (CrCl) from baseline | Up to 12 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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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