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| ID | Type | Description | Link |
|---|---|---|---|
| XA1102 | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site | after approximately 2 years or 30 days after stop of therapy | |
| Number of patients with symptomatic recurrent venous thromboembolic events | after approximately 2 years or 30 days after stop of therapy | |
| All cause mortality | after approximately 2 years or 30 days after stop of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection | after approximately 2 years or 30 days after stop of therapy | |
| Number of patients with other symptomatic thromboembolic events | after approximately 2 years or 30 days after stop of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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In- and outpatients in sites participating in the study
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31249987 | Derived | Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, Bugge JP, Gebel M, Turpie AGG. Patient Management Strategies and Long-Term Outcomes in Isolated Distal Deep-Vein Thrombosis versus Proximal Deep-Vein Thrombosis: Findings from XALIA. TH Open. 2019 Mar 26;3(1):e85-e93. doi: 10.1055/s-0039-1683968. eCollection 2019 Jan. | |
| 26765643 |
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| Standard of care | Drug | Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months |
|
| Treatment satisfaction (patient reported outcomes) | after approximately 2 years or 30 days after stop of therapy |
| Many Locations |
| Belgium |
| Many Locations | Canada |
| Many Locations | Czechia |
| Many Locations | Denmark |
| Many Locations | France |
| Many Locations | Germany |
| Many Locations | Greece |
| Many Locations | Hungary |
| Many Locations | Israel |
| Many Locations | Italy |
| Many Locations | Moldova |
| Many Locations | Netherlands |
| Many Locations | Norway |
| Many Locations | Portugal |
| Many Locations | Slovenia |
| Many Locations | Spain |
| Many Locations | Sweden |
| Many Locations | Switzerland |
| Many Locations | Ukraine |
| Many Locations | United Kingdom |
| Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, van Eickels M, Gebel M, Zell E, Turpie AG. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016 Jan;3(1):e12-21. doi: 10.1016/S2352-3026(15)00257-4. Epub 2015 Dec 8. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013923 | Thromboembolism |
| D054556 | Venous Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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