Coronary Artery Disease, Peripheral Artery Disease
Conditions
Keywords
Thrombosis
Brief 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 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.
Interventions
2.5 mg twice daily
DRUGAcetylsalicylic acid
75 - 100 mg once daily at the discretion of the investigator
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health status by questionnaire EQ-5D-5L | 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). |
| Descriptive analysis of clinical characteristics of CAD participants | At baseline | — |
| Descriptive analysis of clinical characteristics of PAD participants | At baseline | — |
| Descriptive analysis of prior antithrombotic treatment | At baseline | — |
| Descriptive analysis of concomitant antithrombotic treatment | Upto 34 months | — |
| Descriptive analysis of prior secondary prevention therapies | At baseline | — |
| Descriptive analysis of concomitant secondary prevention therapies | Up to 34 months | — |
| Reason to start rivaroxaban | At baseline | Reasons include past ischemic events, co-morbidities and medical history. |
| Decision point to start rivaroxaban | At baseline | Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events |
| Reasons for discontinuation of rivaroxaban | Up to 34 months | — |
| Planned duration of treatment with rivaroxaban | At baseline | — |
| Actual duration of treatment with rivaroxaban | Up to 34 months | — |
| Planned duration of treatment with Acetylsalicylic acid (ASA) | At baseline | — |
| Actual duration of treatment with ASA | Up to 34 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalizations | Up to 34 months | Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications. |
| Pain free walking distance per individual for PAD participants | Up to 34 months | — |
| Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants | 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). |
| Total walking distance per individual for PAD participants | Up to 34 months | — |
| Number of participants with major adverse cardiovascular events (MACE) | Up to 34 months | Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components). |
| Number of participants with major adverse limb events (MALE) | Up to 34 months | Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment \[pattern\] after MALE. |
| Number of participants with antithrombotic treatment after MALE | Up to 34 months | — |
| Number of participants with MACE or MALE | Up to 34 months | Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology. |
| Number of participants with thromboembolic events | Up to 34 months | Thromboembolic events include e.g. systemic embolism and venous thromboembolism. |
| Number of participants with haemorrhagic events and complications | 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. |
| Number of deaths due to cardiovascular events | Up to 34 months | — |
| Number of deaths due to any cause | Up to 34 months | — |
| Number of participants with cardiac revascularization procedures | Up to 34 months | Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) |
| Number of participants with peripheral revascularization procedures | Up to 34 months | — |
| Number of participants with lower limb revascularization procedures. | Up to 34 months | — |
| Number of participants with carotid revascularization procedures | Up to 34 months | — |
| Number of hospitalizations | Up to 34 months | Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications. |
Countries
Belgium, China, Colombia, Italy, Russia, Slovenia, South Korea, Spain, Switzerland, Taiwan
Outcome results
None listed