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AzTrials

Coronary Artery DiseaseXATOCNCT04401761

A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs

An observational study of Coronary Artery Disease and Peripheral Artery Disease, run by Bayer at 10 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban (BAY59-7939, Xarelto) and Acetylsalicylic acid
How many people
3,189 participants
Where
10 sitesin 10 countries
Study dates
28 May 2020to 29 Sep 2023
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
  • Adult, Older adult

Study population: International population of adult CAD/PAD patients

Who may be able to join

  • Adult (≥18 years) patient (except Taiwan ≥ 20 years old).
  • Diagnosis of CAD or symptomatic PAD.
  • Treatment according to local marketing authorization, rivaroxaban 2.5 mg [BID] plus Acetylsalicylic acid (ASA) 75-100 mg [OD] started up to 4 weeks before or after the ICF is signed.
  • Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.

Who cannot join

  • Contra-indications according to the local marketing authorization.
  • Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
  • Participation in an interventional trial.
  • Enrolment in the XATOA study.

Trial locations and contacts

10 sites in 10 countries.

10 sites in 10 countries

Belgium1 site

  • Many Locations

    Multiple Locations

Other trials in Belgium

China1 site

  • Many Locations

    Multiple Locations

Other trials in China

Colombia1 site

  • Many Locations

    Multiple Locations

Other trials in Colombia

Italy1 site

  • Many Locations

    Multiple Locations

Other trials in Italy

Russia1 site

  • Many Locations

    Multiple Locations

Other trials in Russia

Slovenia1 site

  • Many Locations

    Multiple Locations

Other trials in Slovenia

South Korea1 site

  • Many Locations

    Multiple Locations

Other trials in South Korea

Spain1 site

  • Many Locations

    Multiple Locations

Other trials in Spain

Switzerland1 site

  • Many Locations

    Multiple Locations

Other trials in Switzerland

Taiwan1 site

  • Many Locations

    Multiple Locations

Other trials in Taiwan

About this study

Official title: Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD

The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.

Being tested
Rivaroxaban (BAY59-7939, Xarelto), Acetylsalicylic acid
Keywords
Thrombosis
Medical subject headings
Coronary Artery Disease, Peripheral Arterial Disease, Thrombosis

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 at the discretion of the investigator

Study groups in NCT04401761
Study groupRoleWhat they receive
CAD/PAD-patientsAdult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.
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.

  1. Health status by questionnaire EQ-5D-5L

    Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: Up to 34 months

  2. Descriptive analysis of clinical characteristics of CAD participants

    Measured: At baseline

  3. Descriptive analysis of clinical characteristics of PAD participants

    Measured: At baseline

  4. Descriptive analysis of prior antithrombotic treatment

    Measured: At baseline

  5. Descriptive analysis of concomitant antithrombotic treatment

    Measured: Upto 34 months

  6. Descriptive analysis of prior secondary prevention therapies

    Measured: At baseline

  7. Descriptive analysis of concomitant secondary prevention therapies

    Measured: Up to 34 months

  8. Reason to start rivaroxaban

    Reasons include past ischemic events, co-morbidities and medical history.

    Measured: At baseline

  9. Decision point to start rivaroxaban

    Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events

    Measured: At baseline

  10. Reasons for discontinuation of rivaroxaban

    Measured: Up to 34 months

  11. Planned duration of treatment with rivaroxaban

    Measured: At baseline

  12. Actual duration of treatment with rivaroxaban

    Measured: Up to 34 months

  13. Planned duration of treatment with Acetylsalicylic acid (ASA)

    Measured: At baseline

  14. Actual duration of treatment with ASA

    Measured: Up to 34 months

Secondary outcomes (17)

  1. Number of participants with major adverse cardiovascular events (MACE)

    Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).

    Measured: Up to 34 months

  2. Number of participants with major adverse limb events (MALE)

    Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment [pattern] after MALE.

    Measured: Up to 34 months

  3. Number of participants with antithrombotic treatment after MALE

    Measured: Up to 34 months

  4. Number of participants with MACE or MALE

    Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.

    Measured: Up to 34 months

  5. Number of participants with thromboembolic events

    Thromboembolic events include e.g. systemic embolism and venous thromboembolism.

    Measured: Up to 34 months

  6. Number of participants with haemorrhagic events and complications

    The major bleeding complications will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, modified ISTH criteria, and Thrombolysis in Myocardial Infarction (TIMI) criteria.

    Measured: Up to 34 months

  7. Number of deaths due to cardiovascular events

    Measured: Up to 34 months

  8. Number of deaths due to any cause

    Measured: Up to 34 months

  9. Number of participants with cardiac revascularization procedures

    Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)

    Measured: Up to 34 months

  10. Number of participants with peripheral revascularization procedures

    Measured: Up to 34 months

  11. Number of participants with lower limb revascularization procedures.

    Measured: Up to 34 months

  12. Number of participants with carotid revascularization procedures

    Measured: Up to 34 months

  13. Number of hospitalizations

    Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.

    Measured: Up to 34 months

  14. Duration of hospitalizations

    Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.

    Measured: Up to 34 months

  15. Total walking distance per individual for PAD participants

    Measured: Up to 34 months

  16. Pain free walking distance per individual for PAD participants

    Measured: Up to 34 months

  17. Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants

    The WIQ is a validated questionnaire that measures patient-reported walking limitations in distance, stair climbing and speed. Final score ranges from 0 (unable to walk) to 4 (no difficulty to walk).

    Measured: Up to 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start28 May 2020
  3. Primary completion30 Jun 2023
  4. Study completion29 Sep 2023

Resources

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
3,189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401761
Sponsor's protocol ID
21283
Acronym
XATOC
Status last verified
Oct 2023
First submitted
22 May 2020
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Peripheral Artery Disease, run by Bayer at 10 sites in 10 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 4 inclusion and 4 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Belgium, China, Colombia, Italy, Russia and 5 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?

Health status by questionnaire EQ-5D-5L (time frame: Up to 34 months). The study lists 14 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 NCT04401761.

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 25 Oct 2023.

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