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

Bayer3,189 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,189

Conditions

Coronary Artery Disease Peripheral Artery Disease

Interventions

Rivaroxaban (BAY59-7939, Xarelto)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Many Locations

Multiple Locations, Belgium

Many Locations

Multiple Locations, China

Many Locations

Multiple Locations, Colombia

Many Locations

Multiple Locations, Italy

Many Locations

Multiple Locations, Russia

Many Locations

Multiple Locations, Slovenia

Many Locations

Multiple Locations, South Korea

Many Locations

Multiple Locations, Spain

Many Locations

Multiple Locations, Switzerland

Many Locations

Multiple Locations, Taiwan

Outcomes

Primary Outcomes

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).

Time frame: Up to 34 months

Descriptive analysis of clinical characteristics of CAD participants

Time frame: At baseline

Descriptive analysis of clinical characteristics of PAD participants

Time frame: At baseline

Descriptive analysis of prior antithrombotic treatment

Time frame: At baseline

Descriptive analysis of concomitant antithrombotic treatment

Time frame: Upto 34 months

Descriptive analysis of prior secondary prevention therapies

Time frame: At baseline

Descriptive analysis of concomitant secondary prevention therapies

Time frame: Up to 34 months

Reason to start rivaroxaban

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

Time 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

Time frame: At baseline

Reasons for discontinuation of rivaroxaban

Time frame: Up to 34 months

Planned duration of treatment with rivaroxaban

Time frame: At baseline

Actual duration of treatment with rivaroxaban

Time frame: Up to 34 months

Planned duration of treatment with Acetylsalicylic acid (ASA)

Time frame: At baseline

Actual duration of treatment with ASA

Time frame: Up to 34 months

Secondary Outcomes

Number of participants with major adverse cardiovascular events (MACE)

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

Time 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.

Time frame: Up to 34 months

Number of participants with antithrombotic treatment after MALE

Time 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.

Time frame: Up to 34 months

Number of participants with thromboembolic events

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

Time 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.

Time frame: Up to 34 months

Number of deaths due to cardiovascular events

Time frame: Up to 34 months

Number of deaths due to any cause

Time frame: Up to 34 months

Number of participants with cardiac revascularization procedures

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).

Time frame: Up to 34 months