AtherosclerosisXATOANCT03746275
Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid
An observational study of Atherosclerosis, run by Bayer at 18 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Rivaroxaban (BAY59-7939, Xarelto) and Acetylsalicylic acid
- How many people
- 5,798 participants
- Where
- 18 sitesin 18 countries
- Study dates
- 13 Nov 2018to 13 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults in routine medical practice, multi-national
Who may be able to join
- 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.
Who cannot join
- Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- Participation in an interventional trial.
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
United Arab Emirates1 site
Multiple facilities
Multiple Locations
About this study
Official title: 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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Rivaroxaban (BAY59-7939, Xarelto), Acetylsalicylic acid
- Keywords
- Coronary artery disease (CAD), Peripheral artery disease (PAD), Major adverse limb events (MALE), Major adverse cardiac events (MACE), Atherosclerosis, Atherothrombosis, Thrombosis, Embolism, Thromboembolism
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Cardiovascular Diseases, Thrombosis, Embolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (BAY59-7939, Xarelto)Drug
Also called Xarelto
2.5 mg twice daily
Acetylsalicylic acidDrug
Also called Aspirin
75 - 100 mg once daily according to local label
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Rivaroxaban (BAY59-7939, Xarelto); Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of patient history of CAD
Measured: At baseline
Descriptive analysis of patient history of PAD
Measured: At baseline
Descriptive analysis of prior antithrombotic treatment
Measured: At baseline
Descriptive analysis of concomitant antithrombotic treatment
Measured: Up to 30.5 months
Descriptive analysis of prior secondary prevention therapies
Measured: At baseline
Descriptive analysis of concomitant secondary prevention therapies
Measured: Up to 30.5 months
Reason for start of rivaroxaban
Reasons include past ischemic events, co-morbidities and medical history.
Measured: 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.
Measured: At baseline
Reason for discontinuation of rivaroxaban
Measured: Up to 30.5 months
Planned duration of treatment with rivaroxaban
Measured: At baseline
Actual duration of treatment with rivaroxaban
Measured: Up to 30.5 months
Planned duration of treatment with acetylsalicylic acid
Measured: At baseline
Actual duration of treatment with acetylsalicylic acid
Measured: Up to 30.5 months
Secondary outcomes (20)
Occurrence of major adverse cardiac events
Composite measure of stroke, myocardial infarction and cardiovascular death
Measured: Up to 30.5 months
Occurrence of stroke
Measured: Up to 30.5 months
Occurrence of myocardial infarction
Measured: Up to 30.5 months
Occurrence of cardiovascular death
Measured: 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.
Measured: Up to 30.5 months
Occurrence of acute/severe limb ischemia
Measured: Up to 30.5 months
Occurrence of chronic limb ischemia
Measured: Up to 30.5 months
Occurrence of major amputation
Measured: Up to 30.5 months
Anti-thrombotic treatment pattern after major adverse limb event
Treatment pattern comprises drug name, dose and duration of treatment.
Measured: Up to 30.5 months
Occurrence of thromboembolic events
Thromboembolic events include systemic embolism and venous thromboembolism.
Measured: Up to 30.5 months
Occurrence of haemorrhagic events
A haemorrhagic event is any event related to bleeding.
Measured: Up to 30.5 months
Occurrence of death from cardiovascular events
Measured: Up to 30.5 months
Occurrence of death from any cause
Measured: Up to 30.5 months
Occurrence of cardiac revascularization procedures
Includes percutaneous coronary intervention and coronary artery bypass grafting.
Measured: Up to 30.5 months
Occurrence of peripheral revascularization procedures
Measured: Up to 30.5 months
Occurrence of carotid revascularization procedures
Measured: Up to 30.5 months
Occurrence of hospitalizations
Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
Measured: 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.
Measured: Up to 30.5 months
Total walking distance of PAD patients
Measured: Up to 30.5 months
Pain-free walking distance of PAD patients
Measured: Up to 30.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start13 Nov 2018
- Primary completion8 Jun 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746275
- Sponsor's protocol ID
- 20280
- Acronym
- XATOA
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2018
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cornejo-Avendano JR, Novoa C, Peon G, Rapallo C, Alcocer AR, Vita NA, Virgen-Carrillo LR, Barrera-Ramirez CF, Ramacciotti E. Clinical profile, management and outcomes of patients taking dual pathway inhibition for cardiovascular protection in clinical practice in Latin America. Data from the XATOA registry. Drugs Context. 2026 Jun 2;15:2026-1-4. doi: 10.7573/dic.2026-1-4. eCollection 2026.
PubMed 42266552Fox 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.
PubMed 32092505
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study
- ClinicalTrials.gov ID
- NCT03746275
- Acronym / sponsor ID
- XATOA / 20280
- Conditions
- Atherosclerosis
- Keywords
- Coronary artery disease (CAD), Peripheral artery disease (PAD), Major adverse limb events (MALE), Major adverse cardiac events (MACE), Atherosclerosis, Atherothrombosis, Thrombosis, Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,798 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD/PAD-patients | – | Drug: Rivaroxaban (BAY59-7939, Xarelto), Drug: Acetylsalicylic acidAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in routine medical practice, multi-national
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- Participation in an interventional trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (BAY59-7939, Xarelto)Also: Xarelto2.5 mg twice daily | Drug | CAD/PAD-patients |
| Acetylsalicylic acidAlso: Aspirin75 - 100 mg once daily according to local label | Drug | CAD/PAD-patients |
Primary outcome
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
Time frame: At baseline
Reasons include past ischemic events, co-morbidities and medical history.
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.
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
20 secondary outcomes
Occurrence of major adverse cardiac events
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
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
Time frame: Up to 30.5 months
Occurrence of thromboembolic events
Time frame: Up to 30.5 months
Occurrence of haemorrhagic events
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
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
Time frame: Up to 30.5 months
Duration of hospitalization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 42266552Cornejo-Avendano JR, Novoa C, Peon G, Rapallo C, Alcocer AR, Vita NA, Virgen-Carrillo LR, Barrera-Ramirez CF, Ramacciotti E. Clinical profile, management and outcomes of patients taking dual pathway inhibition for cardiovascular protection in clinical practice in Latin America. Data from the XATOA registry. Drugs Context. 2026 Jun 2;15:2026-1-4. doi: 10.7573/dic.2026-1-4. eCollection 2026.
- Derived from this study: PubMed 32092505Fox 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Bayer at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Argentina, Brazil, Canada, Denmark, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of patient history of CAD (time frame: At baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746275, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.