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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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While it is well known that stopping or changing medication with blood thinners in patients who suffer from non-valvular atrial fibrillation (NVAF) increases the risk of ischemic stroke (a condition which occurs when a vessel supplying blood to the brain is obstructed), bleeding or thromboembolism (a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel), limited data are available on the number of NVAF patients and the reasons why NVAF patients in Italy stop or change their treatment with blood thinners to prevent stroke or thromboembolism.
By following the NVAF patients in routine clinical practice in Italy who are treated with rivaroxaban to prevent stroke or systemic embolism researchers want to find out how many NVAF patients and for what reasons NVAF patients stopped or changed rivaroxaban treatment. Study data will be collected through patients' routine visits at their treating doctor over a period of 24 months for each patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVAF patients | Start treatment with rivaroxaban at the discretion of physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Treatment dose is following the description of physicians. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Date of start of rivaroxaban treatment | 24 months | |
| Date of stop of rivaroxaban treatment | 24 months | |
| Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for discontinuation of rivaroxaban therapy |
|
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Inclusion Criteria:
Exclusion Criteria:
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NVAF patients who are treated with rivaroxaban to prevent stroke or non-CNS systemic embolism. Owing to the observational study design, patients will only be enrolled in the study if the decision to treat with rivaroxaban has been made by the treating physician in advance and independent of study inclusion. The decision to prescribe rivaroxaban is solely at the discretion of the investigator and made in accordance with his/her experience in accordance to SmPC.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Italy |
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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| 24 months |
| Reason for dose change of rivaroxaban therapy |
| 24 months |
| Reason for switch to other therapy |
| 24 months |
| Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score) | 24 months |
| 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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