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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-28

Study Completion Date

2023-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAD/PAD-patients

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

Rivaroxaban (BAY59-7939, Xarelto)

Intervention Type DRUG

2.5 mg twice daily

Acetylsalicylic acid

Intervention Type DRUG

75 - 100 mg once daily at the discretion of the investigator

Interventions

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Rivaroxaban (BAY59-7939, Xarelto)

2.5 mg twice daily

Intervention Type DRUG

Acetylsalicylic acid

75 - 100 mg once daily at the discretion of the investigator

Intervention Type DRUG

Other Intervention Names

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Xarelto Aspirin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No