Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

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

5798 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-13

Study Completion Date

2021-07-13

Brief Summary

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In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

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Detailed Description

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The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg \[twice daily\] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg \[twice daily\] plus low-dose ASA \[once daily\]) across the broad range of patient risk profiles encountered in routine clinical practice.

Conditions

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Atherosclerosis

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) from Europe, Asia, Latin America and Canada, who are treated with a combination of rivaroxaban and acetylsalicylic acid to prevent atherothrombotic events

Rivaroxaban (BAY59-7939, Xarelto)

Intervention Type DRUG

2.5 mg twice daily

Acetylsalicylic acid

Intervention Type DRUG

75 - 100 mg once daily according to local label

Interventions

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Rivaroxaban (BAY59-7939, Xarelto)

2.5 mg twice daily

Intervention Type DRUG

Acetylsalicylic acid

75 - 100 mg once daily according to local label

Intervention Type DRUG

Other Intervention Names

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Xarelto Aspirin

Eligibility Criteria

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Inclusion Criteria

* Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD).
* Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.

Exclusion Criteria

* Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
* Participation in an interventional trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple facilities

Multiple Locations, , Argentina

Site Status

Multiple facilities

Multiple Locations, , Brazil

Site Status

Multiple facilities

Multiple Locations, , Canada

Site Status

Multiple facilities

Multiple Locations, , Denmark

Site Status

Multiple facilities

Multiple Locations, , Germany

Site Status

Multiple facilities

Multiple Locations, , Israel

Site Status

Multiple facilities

Multiple Locations, , Lebanon

Site Status

Multiple facilities

Multiple Locations, , Luxembourg

Site Status

Multiple facilities

Multiple Locations, , Mexico

Site Status

Multiple facilities

Multiple Locations, , Norway

Site Status

Multiple facilities

Multiple Locations, , Russia

Site Status

Multiple facilities

Multiple Locations, , Slovenia

Site Status

Multiple facilities

Multiple Locations, , South Korea

Site Status

Multiple facilities

Multiple Locations, , Sweden

Site Status

Multiple facilities

Multiple Locations, , Switzerland

Site Status

Multiple facilities

Multiple Locations, , Thailand

Site Status

Multiple facilities

Multiple Locations, , United Arab Emirates

Site Status

Multiple facilities

Multiple Locations, , United Kingdom

Site Status

Countries

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Argentina Brazil Canada Denmark Germany Israel Lebanon Luxembourg Mexico Norway Russia Slovenia South Korea Sweden Switzerland Thailand United Arab Emirates United Kingdom