check_circleStudy Completed

Coronary artery disease, Peripheral artery disease

Bayer Identifier:

21283

ClinicalTrials.gov Identifier:

NCT04401761

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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 summary

Enrollment Goal
3189
Trial Dates
May 2020 - September 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)+ASA
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Belgium
Completed
Many LocationsMany Locations, Switzerland
Completed
Many LocationsMany Locations, China
Completed
Many LocationsMany Locations, Colombia
Completed
Many LocationsMany Locations, Spain
Completed
Many LocationsMany Locations, Italy
Completed
Many LocationsMany Locations, Korea, Republic Of
Completed
Many LocationsMany Locations, Russian Federation
Completed
Many LocationsMany Locations, Slovenia
Completed
Many LocationsMany Locations, Taiwan
Withdrawn
Many LocationsMany Locations, Brazil
Withdrawn
Many LocationsMany Locations, Canada
Withdrawn
Many LocationsMany Locations, United Kingdom
Withdrawn
Many LocationsMany Locations, Saudi Arabia

Primary Outcome

  • 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).
    date_rangeTime Frame:
    Up to 34 months
  • Descriptive analysis of clinical characteristics of CAD participants
    date_rangeTime Frame:
    At baseline
  • Descriptive analysis of clinical characteristics of PAD participants
    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:
    Upto 34 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 34 months
  • Reason to start rivaroxaban
    Reasons include past ischemic events, co-morbidities and medical history.
    date_rangeTime Frame:
    At baseline
  • Decision point to start rivaroxaban
    Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
    date_rangeTime Frame:
    At baseline
  • Reasons for discontinuation of rivaroxaban
    date_rangeTime Frame:
    Up to 34 months
  • Planned duration of treatment with rivaroxaban
    date_rangeTime Frame:
    At baseline
  • Actual duration of treatment with rivaroxaban
    date_rangeTime Frame:
    Up to 34 months
  • Planned duration of treatment with Acetylsalicylic acid (ASA)
    date_rangeTime Frame:
    At baseline
  • Actual duration of treatment with ASA
    date_rangeTime Frame:
    Up to 34 months

Secondary Outcome

  • Number of participants with major adverse cardiovascular events (MACE)
    Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).
    date_rangeTime Frame:
    Up to 34 months
  • 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.
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with antithrombotic treatment after MALE
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with MACE or MALE
    Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with thromboembolic events
    Thromboembolic events include e.g. systemic embolism and venous thromboembolism.
    date_rangeTime Frame:
    Up to 34 months
  • 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.
    date_rangeTime Frame:
    Up to 34 months
  • Number of deaths due to cardiovascular events
    date_rangeTime Frame:
    Up to 34 months
  • Number of deaths due to any cause
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with cardiac revascularization procedures
    Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with peripheral revascularization procedures
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with lower limb revascularization procedures.
    date_rangeTime Frame:
    Up to 34 months
  • Number of participants with carotid revascularization procedures
    date_rangeTime Frame:
    Up to 34 months
  • Number of hospitalizations
    Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
    date_rangeTime Frame:
    Up to 34 months
  • Duration of hospitalizations
    Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
    date_rangeTime Frame:
    Up to 34 months
  • Total walking distance per individual for PAD participants
    date_rangeTime Frame:
    Up to 34 months
  • Pain free walking distance per individual for PAD participants
    date_rangeTime Frame:
    Up to 34 months
  • 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).
    date_rangeTime Frame:
    Up to 34 months

Trial design

Xarelto + Acetylsalicylic Acid: Treatment patterns and Outcomes across the disease Continuum in patients with CAD and/or PAD
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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