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

• ClinicalTrials.gov Identifier: NCT03746275
• Recruitment Status: Completed
• First Posted: November 19, 2018
• Last Update Posted: May 2, 2022
• Sponsor: Bayer
• Collaborator: Janssen, LP
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Atherosclerosis	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 Design

• Study Type: Observational
• Actual Enrollment: 5798 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study
• Actual Study Start Date: November 13, 2018
• Actual Primary Completion Date: June 8, 2021
• Actual Study Completion Date: July 13, 2021

Groups and Cohorts

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 Name: Xarelto; Drug: Acetylsalicylic acid; 75 - 100 mg once daily according to local label; Other Name: Aspirin

Outcome Measures

Primary Outcome Measures :

1. Descriptive analysis of patient history of CAD [ Time Frame: At baseline ]
2. Descriptive analysis of patient history of PAD [ Time Frame: At baseline ]
3. Descriptive analysis of prior antithrombotic treatment [ Time Frame: At baseline ]
4. Descriptive analysis of concomitant antithrombotic treatment [ Time Frame: Up to 30.5 months ]
5. Descriptive analysis of prior secondary prevention therapies [ Time Frame: At baseline ]
6. Descriptive analysis of concomitant secondary prevention therapies [ Time Frame: Up to 30.5 months ]
7. Reason for start of rivaroxaban [ Time Frame: At baseline ]
   Reasons include past ischemic events, co-morbidities and medical history.
8. Decision point for start of rivaroxaban [ Time Frame: At baseline ]
   Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events.
9. Reason for discontinuation of rivaroxaban [ Time Frame: Up to 30.5 months ]
10. Planned duration of treatment with rivaroxaban [ Time Frame: At baseline ]
11. Actual duration of treatment with rivaroxaban [ Time Frame: Up to 30.5 months ]
12. Planned duration of treatment with acetylsalicylic acid [ Time Frame: At baseline ]
13. Actual duration of treatment with acetylsalicylic acid [ Time Frame: Up to 30.5 months ]

Secondary Outcome Measures :

1. Occurrence of major adverse cardiac events [ Time Frame: Up to 30.5 months ]
   Composite measure of stroke, myocardial infarction and cardiovascular death
2. Occurrence of stroke [ Time Frame: Up to 30.5 months ]
3. Occurrence of myocardial infarction [ Time Frame: Up to 30.5 months ]
4. Occurrence of cardiovascular death [ Time Frame: Up to 30.5 months ]
5. Occurrence of major adverse limb events [ Time Frame: Up to 30.5 months ]
   Major adverse limb events comprise acute/severe limb ischemia including major amputation and chronic limb ischemia.
6. Occurrence of acute/severe limb ischemia [ Time Frame: Up to 30.5 months ]
7. Occurrence of chronic limb ischemia [ Time Frame: Up to 30.5 months ]
8. Occurrence of major amputation [ Time Frame: Up to 30.5 months ]
9. Anti-thrombotic treatment pattern after major adverse limb event [ Time Frame: Up to 30.5 months ]
   Treatment pattern comprises drug name, dose and duration of treatment.
10. Occurrence of thromboembolic events [ Time Frame: Up to 30.5 months ]
    Thromboembolic events include systemic embolism and venous thromboembolism.
11. Occurrence of haemorrhagic events [ Time Frame: Up to 30.5 months ]
    A haemorrhagic event is any event related to bleeding.
12. Occurrence of death from cardiovascular events [ Time Frame: Up to 30.5 months ]
13. Occurrence of death from any cause [ Time Frame: Up to 30.5 months ]
14. Occurrence of cardiac revascularization procedures [ Time Frame: Up to 30.5 months ]
    Includes percutaneous coronary intervention and coronary artery bypass grafting.
15. Occurrence of peripheral revascularization procedures [ Time Frame: Up to 30.5 months ]
16. Occurrence of carotid revascularization procedures [ Time Frame: Up to 30.5 months ]
17. Occurrence of hospitalizations [ Time Frame: Up to 30.5 months ]
    Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
18. Duration of hospitalization [ Time Frame: Up to 30.5 months ]
    Time in days of hospitalization due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
19. Total walking distance of PAD patients [ Time Frame: Up to 30.5 months ]
20. Pain-free walking distance of PAD patients [ Time Frame: Up to 30.5 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adults in routine medical practice, multi-national

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.

Contacts and Locations

Locations

Argentina

Multiple facilities

Multiple Locations, Argentina

Brazil

Multiple facilities

Multiple Locations, Brazil

Canada

Multiple facilities

Multiple Locations, Canada

Denmark

Multiple facilities

Multiple Locations, Denmark

Germany

Multiple facilities

Multiple Locations, Germany

Israel

Multiple facilities

Multiple Locations, Israel

Korea, Republic of

Multiple facilities

Multiple Locations, Korea, Republic of

Lebanon

Multiple facilities

Multiple Locations, Lebanon

Luxembourg

Multiple facilities

Multiple Locations, Luxembourg

Mexico

Multiple facilities

Multiple Locations, Mexico

Norway

Multiple facilities

Multiple Locations, Norway

Russian Federation

Multiple facilities

Multiple Locations, Russian Federation

Slovenia

Multiple facilities

Multiple Locations, Slovenia

Sweden

Multiple facilities

Multiple Locations, Sweden

Switzerland

Multiple facilities

Multiple Locations, Switzerland

Thailand

Multiple facilities

Multiple Locations, Thailand

United Arab Emirates

Multiple facilities

Multiple Locations, United Arab Emirates

United Kingdom

Multiple facilities

Multiple Locations, United Kingdom

Sponsors and Collaborators

Bayer

Janssen, LP

More Information

Additional Information:

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03746275
• Other Study ID Numbers: 20280
• First Posted: November 19, 2018
• Last Update Posted: May 2, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Coronary artery disease (CAD); Peripheral artery disease (PAD); Major adverse limb events (MALE); Major adverse cardiac events (MACE); Atherosclerosis; Atherothrombosis; Thrombosis; Embolism; Thromboembolism

Additional relevant MeSH terms:

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aspirin; Rivaroxaban; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Anticoagulants