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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.
The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg [twice daily] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg [twice daily] plus low-dose ASA [once daily]) across the broad range of patient risk profiles encountered in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/PAD-patients | Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (BAY59-7939, Xarelto) | Drug | 2.5 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of patient history of CAD | At baseline | |
| Descriptive analysis of patient history of PAD | At baseline | |
| Descriptive analysis of prior antithrombotic treatment | At baseline | |
| Descriptive analysis of concomitant antithrombotic treatment | Up to 30.5 months | |
| Descriptive analysis of prior secondary prevention therapies | At baseline | |
| Descriptive analysis of concomitant secondary prevention therapies | Up to 30.5 months | |
| Reason for start of rivaroxaban | Reasons include past ischemic events, co-morbidities and medical history. | At baseline |
| Decision point for start of rivaroxaban | Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events. | At baseline |
| Reason for discontinuation of rivaroxaban | Up to 30.5 months | |
| Planned duration of treatment with rivaroxaban |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major adverse cardiac events | Composite measure of stroke, myocardial infarction and cardiovascular death | Up to 30.5 months |
| Occurrence of stroke | Up to 30.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults in routine medical practice, multi-national
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple facilities | Multiple Locations | Argentina | ||||
| Multiple facilities |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42266552 | Derived | Cornejo-Avendano JR, Novoa C, Peon G, Rapallo C, Alcocer AR, Vita NA, Virgen-Carrillo LR, Barrera-Ramirez CF, Ramacciotti E. Clinical profile, management and outcomes of patients taking dual pathway inhibition for cardiovascular protection in clinical practice in Latin America. Data from the XATOA registry. Drugs Context. 2026 Jun 2;15:2026-1-4. doi: 10.7573/dic.2026-1-4. eCollection 2026. | |
| 32092505 |
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| Acetylsalicylic acid | Drug | 75 - 100 mg once daily according to local label |
|
|
| At baseline |
| Actual duration of treatment with rivaroxaban | Up to 30.5 months |
| Planned duration of treatment with acetylsalicylic acid | At baseline |
| Actual duration of treatment with acetylsalicylic acid | Up to 30.5 months |
| Occurrence of myocardial infarction | Up to 30.5 months |
| Occurrence of cardiovascular death | Up to 30.5 months |
| Occurrence of major adverse limb events | Major adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia. | Up to 30.5 months |
| Occurrence of acute/severe limb ischemia | Up to 30.5 months |
| Occurrence of chronic limb ischemia | Up to 30.5 months |
| Occurrence of major amputation | Up to 30.5 months |
| Anti-thrombotic treatment pattern after major adverse limb event | Treatment pattern comprises drug name, dose and duration of treatment. | Up to 30.5 months |
| Occurrence of thromboembolic events | Thromboembolic events include systemic embolism and venous thromboembolism. | Up to 30.5 months |
| Occurrence of haemorrhagic events | A haemorrhagic event is any event related to bleeding. | Up to 30.5 months |
| Occurrence of death from cardiovascular events | Up to 30.5 months |
| Occurrence of death from any cause | Up to 30.5 months |
| Occurrence of cardiac revascularization procedures | Includes percutaneous coronary intervention and coronary artery bypass grafting. | Up to 30.5 months |
| Occurrence of peripheral revascularization procedures | Up to 30.5 months |
| Occurrence of carotid revascularization procedures | Up to 30.5 months |
| Occurrence of hospitalizations | Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications. | Up to 30.5 months |
| Duration of hospitalization | Time in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications. | Up to 30.5 months |
| Total walking distance of PAD patients | Up to 30.5 months |
| Pain-free walking distance of PAD patients | Up to 30.5 months |
| Multiple Locations |
| Brazil |
| Multiple facilities | Multiple Locations | Canada |
| Multiple facilities | Multiple Locations | Denmark |
| Multiple facilities | Multiple Locations | Germany |
| Multiple facilities | Multiple Locations | Israel |
| Multiple facilities | Multiple Locations | Lebanon |
| Multiple facilities | Multiple Locations | Luxembourg |
| Multiple facilities | Multiple Locations | Mexico |
| Multiple facilities | Multiple Locations | Norway |
| Multiple facilities | Multiple Locations | Russia |
| Multiple facilities | Multiple Locations | Slovenia |
| Multiple facilities | Multiple Locations | South Korea |
| Multiple facilities | Multiple Locations | Sweden |
| Multiple facilities | Multiple Locations | Switzerland |
| Multiple facilities | Multiple Locations | Thailand |
| Multiple facilities | Multiple Locations | United Arab Emirates |
| Multiple facilities | Multiple Locations | United Kingdom |
| Derived |
| Fox KAA, Anand SS, Aboyans V, Cowie MR, Debus ES, Zeymer U, Monje D, Vogtlander K, Lawatscheck R, Gay A. Xarelto plus Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA): Rationale and design of a prospective registry study to assess rivaroxaban 2.5 mg twice daily plus aspirin for prevention of atherothrombotic events in coronary artery disease, peripheral artery disease, or both. Am Heart J. 2020 Apr;222:166-173. doi: 10.1016/j.ahj.2020.01.015. Epub 2020 Jan 28. |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D004617 | Embolism |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D016491 | Peripheral Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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