NCT03746275

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

Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,798 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban (BAY59-7939, Xarelto)	2.5 mg twice daily
DRUG	Acetylsalicylic acid	75 - 100 mg once daily according to local label

Timeline

• Start date: 2018-11-13
• Primary completion: 2021-06-08
• Completion: 2021-07-13
• First posted: 2018-11-19
• Last updated: 2022-05-02

Locations

18 sites across 18 countries: Argentina, Brazil, Canada, Denmark, Germany, Israel, Lebanon, Luxembourg, Mexico, Norway, Russia, Slovenia, South Korea, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom