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.
Study Type
OBSERVATIONAL
Enrollment
5,798
2.5 mg twice daily
75 - 100 mg once daily according to local label
Multiple facilities
Multiple Locations, Argentina
Multiple facilities
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
...and 8 more locations
Descriptive analysis of patient history of CAD
Time frame: At baseline
Descriptive analysis of patient history of PAD
Time frame: At baseline
Descriptive analysis of prior antithrombotic treatment
Time frame: At baseline
Descriptive analysis of concomitant antithrombotic treatment
Time frame: Up to 30.5 months
Descriptive analysis of prior secondary prevention therapies
Time frame: At baseline
Descriptive analysis of concomitant secondary prevention therapies
Time frame: Up to 30.5 months
Reason for start of rivaroxaban
Reasons include past ischemic events, co-morbidities and medical history.
Time frame: 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.
Time frame: At baseline
Reason for discontinuation of rivaroxaban
Time frame: Up to 30.5 months
Planned duration of treatment with rivaroxaban
Time frame: At baseline
Actual duration of treatment with rivaroxaban
Time frame: Up to 30.5 months
Planned duration of treatment with acetylsalicylic acid
Time frame: At baseline
Actual duration of treatment with acetylsalicylic acid
Time frame: Up to 30.5 months
Occurrence of major adverse cardiac events
Composite measure of stroke, myocardial infarction and cardiovascular death
Time frame: Up to 30.5 months
Occurrence of stroke
Time frame: Up to 30.5 months
Occurrence of myocardial infarction
Time frame: Up to 30.5 months
Occurrence of cardiovascular death
Time frame: 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.
Time frame: Up to 30.5 months
Occurrence of acute/severe limb ischemia
Time frame: Up to 30.5 months
Occurrence of chronic limb ischemia
Time frame: Up to 30.5 months
Occurrence of major amputation
Time frame: Up to 30.5 months
Anti-thrombotic treatment pattern after major adverse limb event
Treatment pattern comprises drug name, dose and duration of treatment.
Time frame: Up to 30.5 months
Occurrence of thromboembolic events
Thromboembolic events include systemic embolism and venous thromboembolism.
Time frame: Up to 30.5 months
Occurrence of haemorrhagic events
A haemorrhagic event is any event related to bleeding.
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Time frame: Up to 30.5 months
Occurrence of death from cardiovascular events
Time frame: Up to 30.5 months
Occurrence of death from any cause
Time frame: Up to 30.5 months
Occurrence of cardiac revascularization procedures
Includes percutaneous coronary intervention and coronary artery bypass grafting.
Time frame: Up to 30.5 months
Occurrence of peripheral revascularization procedures
Time frame: Up to 30.5 months
Occurrence of carotid revascularization procedures
Time frame: Up to 30.5 months
Occurrence of hospitalizations
Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
Time frame: 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.
Time frame: Up to 30.5 months
Total walking distance of PAD patients
Time frame: Up to 30.5 months
Pain-free walking distance of PAD patients
Time frame: Up to 30.5 months