check_circleStudy Completed

Atherosclerosis

Bayer Identifier:

20280

ClinicalTrials.gov Identifier:

NCT03746275

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to gain insights in treatment patterns and outcomes in patients with atherosclerosis prescribed to Xarelto in combination with acetylsalicylic acid

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

  • - 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 summary

Enrollment Goal
5798
Trial Dates
November 2018 - July 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)+ASA
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Multiple facilitiesMany locations, Germany
Completed
Multiple facilitiesMany locations, United Kingdom
Withdrawn
Multiple facilitiesMany locations, France
Withdrawn
Multiple facilitiesMany locations, Italy
Withdrawn
Multiple facilitiesMany locations, Spain
Completed
Multiple facilitiesMany locations, Canada
Withdrawn
Multiple facilitiesMany locations, Belgium
Withdrawn
Multiple facilitiesMany locations, Netherlands
Completed
Multiple facilitiesMany locations, Mexico
Completed
Multiple facilitiesMany locations, Sweden
Completed
Multiple facilitiesMany locations, Denmark
Completed
Multiple facilitiesMany locations, Norway
Completed
Multiple facilitiesMany locations, Israel
Completed
Multiple facilitiesMany locations, Argentina
Withdrawn
Multiple facilitiesMany locations, Colombia
Completed
Multiple facilitiesMany locations, Brazil
Completed
Multiple facilitiesMany locations, Russia
Withdrawn
Multiple facilitiesMany locations, Slovakia
Completed
Multiple facilitiesMany locations, Korea, Republic Of
Withdrawn
Multiple facilitiesMany locations, Taiwan
Completed
Multiple facilitiesMany locations, Thailand
Withdrawn
Multiple facilitiesMany locations, Saudi Arabia
Completed
Multiple facilitiesMany locations, Luxembourg
Completed
Multiple facilitiesMany locations, Switzerland
Completed
Multiple facilitiesMany locations, Lebanon
Completed
Multiple facilitiesMany locations, United Arab Emirates
Completed
Multiple facilitiesMany locations, Slovenia

Primary Outcome

  • Descriptive analysis of patient history of CAD
    date_rangeTime Frame:
    At baseline
  • Descriptive analysis of patient history of PAD
    date_rangeTime Frame:
    At baseline
  • Descriptive analysis of prior antithrombotic treatment
    date_rangeTime Frame:
    At baseline
  • Descriptive analysis of concomitant antithrombotic treatment
    date_rangeTime Frame:
    Up to 30.5 months
  • Descriptive analysis of prior secondary prevention therapies
    date_rangeTime Frame:
    At baseline
  • Descriptive analysis of concomitant secondary prevention therapies
    date_rangeTime Frame:
    Up to 30.5 months
  • Reason for start of rivaroxaban
    Reasons include past ischemic events, co-morbidities and medical history.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    At baseline
  • Reason for discontinuation of rivaroxaban
    date_rangeTime Frame:
    Up to 30.5 months
  • Planned duration of treatment with rivaroxaban
    date_rangeTime Frame:
    At baseline
  • Actual duration of treatment with rivaroxaban
    date_rangeTime Frame:
    Up to 30.5 months
  • Planned duration of treatment with acetylsalicylic acid
    date_rangeTime Frame:
    At baseline
  • Actual duration of treatment with acetylsalicylic acid
    date_rangeTime Frame:
    Up to 30.5 months

Secondary Outcome

  • Occurrence of major adverse cardiac events
    Composite measure of stroke, myocardial infarction and cardiovascular death
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of stroke
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of myocardial infarction
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of cardiovascular death
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of acute/severe limb ischemia
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of chronic limb ischemia
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of major amputation
    date_rangeTime Frame:
    Up to 30.5 months
  • Anti-thrombotic treatment pattern after major adverse limb event
    Treatment pattern comprises drug name, dose and duration of treatment.
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of thromboembolic events
    Thromboembolic events include systemic embolism and venous thromboembolism.
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of haemorrhagic events
    A haemorrhagic event is any event related to bleeding.
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of death from cardiovascular events
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of death from any cause
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of cardiac revascularization procedures
    Includes percutaneous coronary intervention and coronary artery bypass grafting.
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of peripheral revascularization procedures
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of carotid revascularization procedures
    date_rangeTime Frame:
    Up to 30.5 months
  • Occurrence of hospitalizations
    Hospitalizations due to stroke, cardiovascular reasons, major adverse limb events or bleeding complications.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 30.5 months
  • Total walking distance of PAD patients
    date_rangeTime Frame:
    Up to 30.5 months
  • Pain-free walking distance of PAD patients
    date_rangeTime Frame:
    Up to 30.5 months

Trial design

Xarelto + Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis. A non-interventional study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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