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

April 27, 2022 updated by: Bayer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5798

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Descriptive analysis of patient history of CAD
Time Frame: At baseline
At baseline
Descriptive analysis of patient history of PAD
Time Frame: At baseline
At baseline
Descriptive analysis of prior antithrombotic treatment
Time Frame: At baseline
At baseline
Descriptive analysis of concomitant antithrombotic treatment
Time Frame: Up to 30.5 months
Up to 30.5 months
Descriptive analysis of prior secondary prevention therapies
Time Frame: At baseline
At baseline
Descriptive analysis of concomitant secondary prevention therapies
Time Frame: Up to 30.5 months
Up to 30.5 months
Reason for start of rivaroxaban
Time Frame: At baseline
Reasons include past ischemic events, co-morbidities and medical history.
At baseline
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.
At baseline
Reason for discontinuation of rivaroxaban
Time Frame: Up to 30.5 months
Up to 30.5 months
Planned duration of treatment with rivaroxaban
Time Frame: At baseline
At baseline
Actual duration of treatment with rivaroxaban
Time Frame: Up to 30.5 months
Up to 30.5 months
Planned duration of treatment with acetylsalicylic acid
Time Frame: At baseline
At baseline
Actual duration of treatment with acetylsalicylic acid
Time Frame: Up to 30.5 months
Up to 30.5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of major adverse cardiac events
Time Frame: Up to 30.5 months
Composite measure of stroke, myocardial infarction and cardiovascular death
Up to 30.5 months
Occurrence of stroke
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of myocardial infarction
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of cardiovascular death
Time Frame: Up to 30.5 months
Up to 30.5 months
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.
Up to 30.5 months
Occurrence of acute/severe limb ischemia
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of chronic limb ischemia
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of major amputation
Time Frame: Up to 30.5 months
Up to 30.5 months
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.
Up to 30.5 months
Occurrence of thromboembolic events
Time Frame: Up to 30.5 months
Thromboembolic events include systemic embolism and venous thromboembolism.
Up to 30.5 months
Occurrence of haemorrhagic events
Time Frame: Up to 30.5 months
A haemorrhagic event is any event related to bleeding.
Up to 30.5 months
Occurrence of death from cardiovascular events
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of death from any cause
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of cardiac revascularization procedures
Time Frame: Up to 30.5 months
Includes percutaneous coronary intervention and coronary artery bypass grafting.
Up to 30.5 months
Occurrence of peripheral revascularization procedures
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of carotid revascularization procedures
Time Frame: Up to 30.5 months
Up to 30.5 months
Occurrence of hospitalizations
Time Frame: Up to 30.5 months
Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
Up to 30.5 months
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.
Up to 30.5 months
Total walking distance of PAD patients
Time Frame: Up to 30.5 months
Up to 30.5 months
Pain-free walking distance of PAD patients
Time Frame: Up to 30.5 months
Up to 30.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen, LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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