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| ID | Type | Description | Link |
|---|---|---|---|
| XAR-PE-DVT | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Rivaroxavban administration group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Treatment parameters following the summary of product characteristics and the physician's decision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability | Up to 2 years | |
| Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs | Up to 2 years | |
| Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period |
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Inclusion Criteria:
- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
Exclusion Criteria:
- Patients who are contraindicated based on the product label and have already received Xarelto treatment.
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Female and male patients who start rivaroxaban for VTE (pulmonary embolism, deep vein thrombosis) anticoagulation therapy
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37245989 | Derived | Fukuda I, Hirayama A, Kawasugi K, Kobayashi T, Maeda H, Nakamura M, Yamada N, Tajima T, Tachiiri M, Okayama Y, Sunaya T, Hirano K, Hayasaki T. Safety Profile and Effectiveness of Rivaroxaban for Patients With Venous Thromboembolism in Japan - Results From Post-Marketing Surveillance (XASSENT). Circ J. 2023 Aug 25;87(9):1175-1184. doi: 10.1253/circj.CJ-23-0104. Epub 2023 May 27. |
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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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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| 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 |
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| at 1 year |
| Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes | Up to 2 years |
| D013927 |
| Thrombosis |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |