Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (BAY59-7939, Xarelto)
* Drug: Acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD). Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made. Exclusion Criteria: Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD. Participation in an interventional trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAD/PAD-patients<br>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 | Drug: Rivaroxaban (BAY59-7939, Xarelto)<br>* 2.5 mg twice daily<br>* Other names: Xarelto;Drug: Acetylsalicylic acid<br>* 75 - 100 mg once daily according to local label<br>* Other names: Aspirin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease (CAD), Peripheral artery disease (PAD), Major adverse limb events (MALE), Major adverse cardiac events (MACE), Atherosclerosis, Atherothrombosis, Thrombosis, Embolism, Thromboembolism