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Completed

NCT Number: NCT03746275

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple facilities, Multiple Locations, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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 according to local label

Other names: Aspirin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen, LP

Registry information

Official study title

Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study

Acronym: XATOA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
May 2, 2022

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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