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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions.
The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period.
The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Rivaroxaban treatment-naïve patients, at least 18 years of age and presenting with NVAF will be considered eligible for participation in this study only after the decision to treat with rivaroxaban has been made by the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto,Bay 59-7939) | Drug | 15 mg and 20 mg (OD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major bleeding events | Major bleeding events include:
| Up to 18 months |
| Incidence of treatment-emergent AEs | Up to 18 months | |
| Incidence of treatment-emergent SAEs | Up to 18 months | |
| Incidence of all-cause death | Deaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection). | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic thromboembolic events | The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded. The thromboembolic events include:
| Up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients ≥18 years of age with a diagnosis of NVAF will be enrolled only after the decision for treatment with rivaroxaban has been made by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunshine Hospital | Secunderabad | National Capital Territory of Delhi | 500003 | India |
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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| Non-major bleeding events | The date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected. | Up to 18 months |
| AE rates in the different NVAF risk factor categories | Rates of AEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke(CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED). | Up to 18 months |
| SAE rates in the different NVAF risk factor categories | Rates of SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke (CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED). | Up to 18 months |
| Treatment persistence with rivaroxaban | Treatment persistence with rivaroxaban therapy will be defined as the absence of a gap of >60 days between two doses of rivaroxaban, without any switch to alternative anticoagulant. Reasons for any switch from or interruption of rivaroxaban therapy during the observation period will be collected and summarized. | Up to 18 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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