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Completed

NCT Number: NCT04401761

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Embolism and Thrombosis Heart Diseases Myocardial Ischemia Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Belgium

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Rivaroxaban (BAY59-7939, Xarelto)

Drug

2.5 mg twice daily

Other names: Xarelto

acetylsalicylic acid

Drug

75 - 100 mg once daily at the discretion of the investigator

Other names: Aspirin

Primary outcomes

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

    Time frame: Up to 34 months

    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).

  2. Descriptive analysis of clinical characteristics of CAD participants

    Time frame: At baseline

  3. Descriptive analysis of clinical characteristics of PAD participants

    Time frame: At baseline

  4. Descriptive analysis of prior antithrombotic treatment

    Time frame: At baseline

  5. Descriptive analysis of concomitant antithrombotic treatment

    Time frame: Upto 34 months

  6. Descriptive analysis of prior secondary prevention therapies

    Time frame: At baseline

  7. Descriptive analysis of concomitant secondary prevention therapies

    Time frame: Up to 34 months

  8. Reason to start rivaroxaban

    Time frame: At baseline

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

  9. Decision point to start rivaroxaban

    Time frame: At baseline

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

  10. Reasons for discontinuation of rivaroxaban

    Time frame: Up to 34 months

  11. Planned duration of treatment with rivaroxaban

    Time frame: At baseline

  12. Actual duration of treatment with rivaroxaban

    Time frame: Up to 34 months

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

    Time frame: At baseline

  14. Actual duration of treatment with ASA

    Time frame: Up to 34 months

Secondary outcomes

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

    Time frame: Up to 34 months

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

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

    Time frame: Up to 34 months

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

  3. Number of participants with antithrombotic treatment after MALE

    Time frame: Up to 34 months

  4. Number of participants with MACE or MALE

    Time frame: Up to 34 months

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

  5. Number of participants with thromboembolic events

    Time frame: Up to 34 months

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

  6. Number of participants with haemorrhagic events and complications

    Time frame: Up to 34 months

    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.

  7. Number of deaths due to cardiovascular events

    Time frame: Up to 34 months

  8. Number of deaths due to any cause

    Time frame: Up to 34 months

  9. Number of participants with cardiac revascularization procedures

    Time frame: Up to 34 months

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

  10. Number of participants with peripheral revascularization procedures

    Time frame: Up to 34 months

  11. Number of participants with lower limb revascularization procedures.

    Time frame: Up to 34 months

  12. Number of participants with carotid revascularization procedures

    Time frame: Up to 34 months

  13. Number of hospitalizations

    Time frame: Up to 34 months

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

  14. Duration of hospitalizations

    Time frame: Up to 34 months

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

  15. Total walking distance per individual for PAD participants

    Time frame: Up to 34 months

  16. Pain free walking distance per individual for PAD participants

    Time frame: Up to 34 months

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

    Time frame: Up to 34 months

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: XATOC

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 26, 2020
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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