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

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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Drug: Rivaroxaban (BAY59-7939, Xarelto); Drug: Acetylsalicylic acid

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.

• Study Type: Observational
• Enrollment (Actual): 5798

Contacts and Locations

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Multiple facilities
• Brazil
  • Multiple Locations, Brazil
    • Multiple facilities
• Canada
  • Multiple Locations, Canada
    • Multiple facilities
• Denmark
  • Multiple Locations, Denmark
    • Multiple facilities
• Germany
  • Multiple Locations, Germany
    • Multiple facilities
• Israel
  • Multiple Locations, Israel
    • Multiple facilities
• Korea, Republic of
  • Multiple Locations, Korea, Republic of
    • Multiple facilities
• Lebanon
  • Multiple Locations, Lebanon
    • Multiple facilities
• Luxembourg
  • Multiple Locations, Luxembourg
    • Multiple facilities
• Mexico
  • Multiple Locations, Mexico
    • Multiple facilities
• Norway
  • Multiple Locations, Norway
    • Multiple facilities
• Russian Federation
  • Multiple Locations, Russian Federation
    • Multiple facilities
• Slovenia
  • Multiple Locations, Slovenia
    • Multiple facilities
• Sweden
  • Multiple Locations, Sweden
    • Multiple facilities
• Switzerland
  • Multiple Locations, Switzerland
    • Multiple facilities
• Thailand
  • Multiple Locations, Thailand
    • Multiple facilities
• United Arab Emirates
  • Multiple Locations, United Arab Emirates
    • Multiple facilities
• United Kingdom
  • Multiple Locations, United Kingdom
    • Multiple facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults in routine medical practice, multi-national

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Rivaroxaban (BAY59-7939, Xarelto); 2.5 mg twice daily; Other Names: Xarelto; Drug: Acetylsalicylic acid; 75 - 100 mg once daily according to local label; 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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen, LP

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Atherosclerosis; Embolism; Thrombosis; Thromboembolism; Atherothrombosis; Coronary artery disease (CAD); Peripheral artery disease (PAD); Major adverse limb events (MALE); Major adverse cardiac events (MACE)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Rivaroxaban
• Other Study ID Numbers: 20280

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No