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 (XATOC)

Bayer

Status: Completed

Conditions: Coronary Artery Disease; Peripheral Artery Disease

Treatments: Drug: Acetylsalicylic acid; Drug: Rivaroxaban (BAY59-7939, Xarelto)

Study type: Observational

Funder types: Industry

Identifiers

NCT04401761

21283

Details and patient eligibility

About

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.

Enrollment: 3,189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,189 participants in 1 patient group

CAD/PAD-patients

Description:

Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.

Treatment:

Drug: Rivaroxaban (BAY59-7939, Xarelto)

Drug: Acetylsalicylic acid